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Human DNA alone does not produce a positive result on the RT-PCR test for SARS-CoV-2 – Health Feedback

Posted: August 31, 2020 at 8:09 pm

CLAIM

WHO coronavirus PCR test primer sequence is found in all human DNA; this means that the WHO test kits should find a positive result in all humans

DETAILS

Fails to grasp significance of observation: In order for the PCR amplification process to begin, it is essential for both primers to flank the same target sequence. Having only a single primer that binds to a sequence does not lead to amplification and produces a negative test result.Flawed reasoning: If the SARS-CoV-2 RT-PCR test detected human DNA, then all tests would return a positive result. This is clearly contradicted by the fact that only about 9% of all tests administered in the U.S. have been positive.

KEY TAKE AWAY

The reverse-transcription PCR (RT-PCR) test is the method of choice for detecting SARS-CoV-2 in samples and is highly specific for the virus. For a PCR test to successfully amplify nucleic acids (DNA or RNA) in a sample, it is necessary for a pair of primers, which are short sequences of single-stranded nucleic acids that recognize and bind to a specific region of the genome, to flank the same target sequence. If only one primer in the pair is able to do so, amplification does not take place and the test would produce a negative result. Therefore, an RT-PCR test for SARS-CoV-2 which uses a primer that matches a human gene sequence would produce a negative result if only human DNA alone were present.

REVIEW A blog post claiming that the SARS-CoV-2 nucleic acid test would give positive results for every test because it also identifies human DNA was published in April 2020 and has received more than 13,000 interactions on Facebook and other social media platforms like Reddit, according to social media analytics tool CrowdTangle. While it was published several months ago, the article has seen a resurgence of interest on social media in August 2020.

Claims calling into question the nucleic acid tests used to detect SARS-CoV-2 are not new; Health Feedback also reviewed a related claim that the PCR test would detect other coronaviruses and found it to be false, as the test is highly specific and does not detect genetic material from other coronaviruses.

The Piece of Mindful blog post takes a different tack from the earlier claim by citing the protocol of a SARS-CoV-2 nucleic acid test developed at the Pasteur Institute in Paris, which is available on the website of the World Health Organization. The protocol lists the nucleotide sequences of various primers used in the test. According to the blog post, the sequence of one primer matches that of a sequence found on the human chromosome 8 and because of this, the post claims that the test would also detect human DNA, thereby giving false-positive results. As we explain below, this claim stems from a fundamental misunderstanding of how PCR works.

The laboratory technique known as PCR, or polymerase chain reaction, is a widely-used technique in laboratories worldwide that was invented by Kary Mullis, who received the 1993 Nobel Prize in Chemistry for this work. PCR is used to make many copies of a particular segment of nucleic acid (DNA/RNA), a process known as amplification, which enables scientists to detect tiny amounts of nucleic acid in a sample (see animation video by Cold Spring Harbor Laboratorys DNA Learning Center below).

The method of choice for detecting SARS-CoV-2 in most countries is a variant of PCR which detects RNA, called reverse transcription PCR (RT-PCR) (SARS-CoV-2 is an RNA virus).

Our knowledge of the SARS-CoV-2 genetic sequence allows us to design primers that specifically bind to sequences that are unique to the virus, based on the principle of complementary base pairing. These primers are required to start the amplification process. In the protocol, the primers in question detect the presence of the gene sequence for RNA-dependent RNA polymerase (RdRp), which encodes an enzyme that is needed to make more copies of the viral genome[1].

However, primers act in pairs. In order to begin the amplification process, it is essential for both the forward and reverse primers to bind/anneal and flank the same target sequence. Although the sequence CTCCCTTTGTTGTGTTGT which matches the reverse primer also exists on the human chromosome 8, the forward primer listed in the protocol (ATGAGCTTAGTCCTGTTG) does not bind to any sequence on chromosome 8. We demonstrate this below by using the Basic Local Alignment Search Tool (BLAST), developed by the U.S. National Center for Biotechnology Information, to align the forward primer listed in the protocol with the human genome.

As we can see from the alignment results, none of the sequences among the top matches in the list, which are partial matches, can be found on chromosome 8:

In summary, although the sequence CTCCCTTTGTTGTGTTGT is present in the human chromosome 8, only one of the primers is able to recognize this sequence, which would produce a negative result if only human DNA was present. Therefore the claim that the PCR test would produce a false-positive result due to human DNAand the implication that the number of positive SARS-CoV-2 test results is artificially inflatedis incorrect and misleading. Furthermore, it is evident from testing statistics that not all tests produce positive results; according to the U.S. Centers for Disease Control and Preventions COVID Data Tracker, only 9% of all tests conducted in the U.S. are positive as of 30 August 2020, as Lead Stories pointed out in their fact-check of the same blog post:

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A Man Was Reinfected with Coronavirus After RecoveryWhat Does This Mean for Immunity? – UPJ Athletics

Posted: at 8:09 pm

This article was written by Megan Culler Freeman, a pediatric infectious disease fellow at Pitt,for The Conversation. Faculty members and researchers who want to learn more about publishing in The Conversation canread about the process here.

A 33-year old man was found to have a second SARS-CoV-2 infection some four-and-a-half months after he was diagnosed with his first, from which he recovered. The man, who showed no symptoms, was diagnosed when he returned to Hong Kong after a trip to Spain.

I am a virologist with expertise in coronaviruses and enteroviruses, and Ive been curious about reinfections since the beginning of the pandemic. Because people infected with SARS-CoV-2 can often test positive for the virus for weeks to months, likely due to the sensitivity of the test and leftover RNA fragments, the only way to really answer the question of reinfection is by sequencing the viral genome at the time of each infection and looking for differences in the genetic code.

There is no published peer-review report on this manonly a press release from the University of Hong Kongalthough reports say the work will be published in the journal Clinical Infectious Diseases. Here I address some questions raised by the current news reports.

Immunity to endemic coronavirusesthose that cause symptoms of the common coldis relatively short-lived, with reinfections occurring even within the same season. So it isnt completely surprising that reinfection with SARS-CoV-2, the virus that causes COVID-19, might be possible.

Immunity is complex and involves multiple mechanisms in the body. That includes the generation of antibodiesthrough whats known as the adaptive immune responseand through the actions of T-cells, which can help to educate the immune system and to specifically eliminate virus-infected cells. However, researchers around the world are still learning about immunity to this virus and so cant say for sure, based on this one case, whether reinfection will be a cause for broad concern.

Strain has a particular definition when referring to viruses. Often a different strain is a virus that behaves differently in some way. The coronavirus that infected this man in Europe is likely not a new strain.

A STAT News article reports that the genetic make up of the sequenced virus from the patients second infection had 24 nucleotidesbuilding blocks of the viruss RNA genomethat differed from the SARS-CoV-2 isolate that infected him the first time.

SARS-CoV-2 has a genome that is made up of about 30,000 nucleotides, so the virus from the mans second infection was roughly 0.08% different than the original in genome sequence. That shows that the virus that caused the second infection was new; not a recurrence of the first virus.

The man wasnt suffering any of the hallmark COVID-19 symptoms which might mean he had some degree of protective immunity to the second infection because he didnt seem sick. But this is difficult to prove.

I see three possible explanations. The first is that the immunity he gained from the first infection protected him and allowed for a mild second infection. Another possibility is that the infection was mild because he was presymptomatic, and went on to develop symptoms in the coming days. Finally, sometimes infections with SARS-CoV-2 are asymptomaticat the moment it is difficult to determine whether this was due to the differences in the virus or in the host.

Only that it seems to be possible after enough time has elapsed. We do not know how likely or often it is to occur.

As we are still learning about how humans develop immunity to SARS-CoV-2 after infection, my recommendation is for continued masking, hand hygiene and distancing practices, even after recovery from COVID-19, to protect against the potential for reinfection.

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Genomic Study Has Discovered Which Animals Can Get Coronavirus – The National Interest

Posted: at 8:09 pm

There already have been plenty of reports detailing that dogs and cats can be infected by the novel coronavirus.

Chimpanzees and gorillas? Not a huge surprise that theyre susceptible. But what about giant anteaters, bottlenose dolphins, sheep, minks, and Siberian tigers?

Its an emphatic yes to those animals, too, according to a team of researchers at the University of California, Davis.

The new study, which was published in the Proceedings of the National Academy of Sciences, has found that any animal that has the same enzyme that SARS-CoV-2 uses to infect human beings is also at risk of infection from coronavirus.

That particular enzyme is called ACE2, which can be found in a number of different cells in the human body, including the epithelial cells on the lungs, nose, and mouth. When infecting humans, the coronavirus binds itself to twenty-five amino acids of the ACE2 enzyme.

We identified a large number of mammals that can potentially be infected by SARS-CoV-2 via their ACE2 proteins, the studys authors wrote.

This can assist the identification of intermediate hosts for SARS-CoV-2 and hence reduce the opportunity for a future outbreak of COVID-19.

In other words, the animals that have the same twenty-five amino acids in those ACE2 enzymes have the highest risk of contracting the virus.

In addition to discovering some surprises as to which animals were susceptible to coronavirus, the researchers are hoping that their efforts might help protect vulnerable endangered speciesespecially great apes, which were shown to be nearly as susceptible as humans, according to the study.

Among the species we found with the highest risk for SARS-CoV-2 infection are wildlife and endangered species, the study stated.

These species represent an opportunity for spillover of SARS-CoV-2 from humans to other susceptible animals.

In the United States, more than twenty-five dogs and cats have been confirmed to be infected with coronavirus, according to the United States Department of Agriculture.

But the Centers for Disease Control and Prevention has stated that owners of pets do not have to worry about the potential for transmission.

The virus that causes COVID-19 spreads mostly from person to person through respiratory droplets from coughing, sneezing, and talking, the CDC states.

Recent studies indicate that people who are infected but do not have symptoms likely also play a role in the spread of COVID-19. At this time, there is no evidence that companion animals, including pets, can spread COVID-19 to people or that they might be a source of infection in the United States.

The agency is recommending that owners prevent their pets from interacting with people or animals outside their homes. If they are outside, the pets should maintain at least a six-foot distance.

Treat pets as you would other human family members, the CDC said.

If a pet owner tests positive for the virus or believes he or she is sick, all contact with the animal should be immediately cut off, the agency added.

Ethen Kim Lieser is a Minneapolis-based Science and Tech Editor who has held posts at Google, The Korea Herald, Lincoln Journal Star, AsianWeek and Arirang TV. Follow or contact him on LinkedIn.

Image: Reuters.

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Broad Researchers Identify February Biogen Conference as Source of Tens of Thousands of COVID-19 Cases | News – Harvard Crimson

Posted: at 8:09 pm

Broad Institute researchers identified a conference held by the Cambridge-based company Biogen in February as a superspreading event for COVID-19 that caused tens of thousands subsequent cases in the Boston area.

The study, which tracked occurrences of unique COVID-19 genomes from a dataset of the earliest known cases of the virus in Massachusetts, was led by researchers from the Broad Institute and various universities. The team used viral genome sequencing a process of decoding the nucleotides within a given genome to find over 80 separate introductions of COVID-19 into Massachusetts.

The team marked the Biogen conference as a COVID-19 superspreading event after discovering that a specific variation of the virus containing the C2416T allele had contributed to 35.1 percent of COVID-19 cases studied in the dataset. Using the frequency of the allele in four Massachusetts counties, the study estimated that around 20,000 cases in the counties could be attributed to the event.

Samples from the Boston Health Care for the Homeless Program also revealed that the COVID-19 variation introduced at the conference spread into Boston homeless shelters.

In a statement provided by a Broad spokesperson, Broad scientists Bronwyn MacInnis and Stephen Schaffner members of the team wrote that the event most likely led to even more COVID-19 cases outside the Boston area.

This back-of-the-envelope calculation does not include other counties in MA or any other US states or any other countries, they wrote. It thus seems likely that this is an event whose impact is measured in tens of thousands of individuals, but a precise estimate of the total number involved is not possible with current data.

The study also found that effective isolation processes had resulted in lower rates of COVID-19 spread. Schaffner wrote in a Broad website post that a skilled nursing facility studied by the group had a lesser impact on the general Massachusetts population than the Biogen conference.

The outbreak in the nursing facility was devastating for those involved, but it occurred in a fairly isolated population, Schaffner wrote. As a result, it caused little transmission outside the facility. The outbreak in the conference, by contrast, occurred in a highly mobile population in late February and spilled out into the larger community.

Although the study accounted for almost all early confirmed COVID-19 cases, Lydia A. Krasilnikova, a Harvard graduate student and member of the team, wrote in an emailed that asymptomatic cases were not a focus of this study.

It is entirely possible that there were additional asymptomatic cases in Massachusetts, even in the Boston area, that were not captured in our samplingindeed, I would be very surprised if we captured all cases from early in the Massachusetts outbreak, she wrote.

Krasilnikova wrote that the team plans to continue its collaborations with the Massachusetts Department of Public Health and Massachusetts General Hospital while continuing to use genomic sequencing to better understand the virus.

Genomic epidemiology, especially combined with traditional epidemiology, can show us if cases or clusters of cases are connected: this can, with enough sampling, determine whether disease is being continually reintroduced into a community or is spreading within it, she wrote. These scenarios require different responses; genomic epidemiology can equip leaders with the information they need to make difficult and urgent decisions.

Staff writer Ethan Lee can be reached at ethan.lee@thecrimson.com.

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Microbes Living Deep Below Earth’s Surface Could Be Remnants of Ancient Life Forms – ScienceAlert

Posted: at 8:09 pm

There's an enormous variety of life thriving deep beneath Earth's surface. A new analysis of two major groups of subsurface microbes has now revealed that their evolutionary path to life in the dark has been more curious than we expected.

In our planet's first 2 billion years of existence, there was no oxygen in the atmosphere. Once the air on our blue planet changed, not all life forms adapted, with many microbes retreating into less oxygenated parts of the planet.

Patescibacteria and DPANN are two ubiquitous groups of such subsurface microbes - bacteria and archaea, respectively - that appear to have very simple genomes. This has led many to suspect that without the ability to breathe oxygen, these microbes might need to rely on complex interactions with other organisms to supplement their simple lifestyles.

Now, it seems we may not be giving them enough credit. New research indicates that instead of having a symbiotic dependency on other major groups of organisms, most Patescibacteria and DPANN live as completely free cells.

"These microbes [..] are really special, really exciting examples of the early evolution of life,"saysRamunas Stepanauskas, who studies microbial biology and evolution at the Bigelow Laboratory for Ocean Sciences.

"They may be remnants of ancient forms of life that had been hiding and thriving in the Earth's subsurface for billions of years."

Previous work on Patescibacteria and DPANN has gathered a small number of examples near the surface of the Earth, and mainly in North America, but this new study goes deeper and wider than ever before, analysing nearly 5,000 individual microbial cells from 46 locations around the globe, including a mud volcano on the bottom of the Mediterranean Sea, hydrothermal vents in the Pacific, and gold mines in South Africa.

"Our single cell genomic and biophysical observations do not support the prevailing view that Patescibacteria and DPANN are dominated by symbionts," the authors write.

"Their divergent coding potential, small genomes, and small cell sizes may be a result of an ancestral, primitive energy metabolism that relies solely on [fermentation]."

Fermentation is one of the metabolic options living organisms have for breaking down glucose without the help of oxygen, and many life forms use fermentation for energy production, especially the microbes that don't breathe air at all.

However, using fermentation is less efficient than breathing - it produces only 2 ATP per glucose compared to 38 ATP per glucose with aerobic respiration - so this type of metabolism comes with the cost of putting organisms in the metabolic slow lane.

Patescibacteria and DPANN are just fine with that, however. Based on the new analysis, the two groupscontain no trace of what's known as an electron transport chain, a metabolic process that makes energy by dumping electrons onto oxygen. Their relatively simple, potentially ancient survival tricks simply don't need it.

Genomic research and direct experimental tests on samples representing the two groups showed no evidence of respiration, and close examination of cell-to-cell links revealed most were on their own, not attached to hostslike some of their surface cousins.

The authors can't deny that some symbiotic relationships could have been shaken apart by human handling, but gentle mixing was attempted when sorting the cells.

Even if the team is underestimating cell-to-cell interactions, genomic analysis found no evidence of evolutionary enrichment from symbiotic relationships compared to other phyla.

Rather, genome content and lab analysis of cell physiology suggests these microbial groups contain few, if any, other ways of producing energy than fermentation.

"Our findings indicate that Patescibacteria and DPANN are ancient forms of life that may have never learned how to breathe,"saysStepanauskas.

"These two major branches of the evolutionary tree of life constitute a large portion of the total microbial diversity on the planet - and yet they lack some capabilities that are typically expected in every form of life."

The study was published in Frontiers in Microbiology.

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Researchers announce likely case of coronavirus reinfection in Reno – KTNV Las Vegas

Posted: at 8:09 pm

Scientists at the University of Nevada, Reno School of Medicine (UNR Med), led by its Nevada State Public Health Laboratory (NSPHL) are studying a likely case of COVID-19 reinfection.

Forty-eight days after testing positive for SARS-CoV-2 in April 2020 and after testing negative consecutively twice, a Washoe County, Nevada patient tested positive again, in June.

The patient had tested negative on two separate occasions in the interim. The genomes of the patients virus samples were sequenced in April and June, displaying significant genetic discordance between the two cases, implying the patient was infected twice.

We examined the genomic material of the viruses and samples to investigate this, says NSPHL Director Mark Pandori. It is just one finding, but it shows that a person can possibly become infected with SARS-CoV-2 a second time.

To solidify confidence in the case, Pandori and the research team partnered with the Washoe County Sheriffs Office Biology Unit to conduct identity testing on the specimens and lab samples evaluated in the study to verify the specimens were from the same person.

MORE CORONAVIRUS NEWS

Embedded in the genomic material of SARS-CoV-2 is a detailed code that Pandori says may provide insight to better understanding of this virus.

A virus has a biological genome like all living things. Since March, the NSPHL has analyzed the genomic RNA of approximately 200 positive COVID-19 samples from Nevadans who have tested positive for COVID-19, said Pandori. The power of genomic information could turn the tables in the fight against the coronavirus. The information is shared to a world-wide database known as GISAID, alongside the work of thousands of researchers.

According to Pandori and the NSPHL-led research team, reinfection cases are a potential warning sign that it is possible to catch COVID-19 more than once, and with unpredictable severity.

If reinfection is possible on such a short timeline, there may be implications for the efficacy of vaccines developed to fight the disease. It may also have implications for herd immunity, says Pandori. It is important to note, that this is a singular finding. It does not provide any information to us with regard to the generalizability of this phenomenon.

Herd immunity depends on the theory that after natural infection, our immune systems will collectively protect us as a community from reinfection and further spread.There are currently many more unknowns than knowns about immune responses to COVID-19. After one recovers from COVID-19, we still do not know how much immunity is built up, how long it may last, or how well antibodies play a role in protection against a reinfection, says Pandori.

While research and scientific advancements continue to build, Pandori says the hard work of fighting this pandemic together will continue through the use of facial coverings, hand-washing, social distancing, as well as wide-scale testing, contact tracing, and isolation of new cases.

This is a novel disease. We still have a steep learning curve ahead and lots of work to do, especially as inconvenient truths arise, says Pandori.

The NSPHL team are publishing their COVID-19 reinfection findings. Their report is publicly accessible on the SSRN preprint server, at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3681489.

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Cancer Genetics and StemoniX Sign Definitive Agreement to Merge – GlobeNewswire

Posted: August 26, 2020 at 4:17 pm

Combined Company Positioned to Offer Best-in-Class and Innovative Drug Discovery Solutions

RUTHERFORD, NJ and MAPLE GROVE, MN, Aug. 24, 2020 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (the Company) (Nasdaq: CGIX), and StemoniX, Inc., today announced the entry into a definitive merger agreement. Cancer Genetics is a leader in drug discovery and preclinical oncology and immuno-oncology services. StemoniX, a privatecompany, isa leader in developing high-throughput disease-specifichuman organoid platforms integrated withleading-edge data science technologies. Under the terms of the merger agreement, StemoniX will merge with a newly formed subsidiary of Cancer Genetics in an all-equity transaction. Upon shareholder approval, the combined company expects to remain listed on the Nasdaq Stock Market. StemoniX will retain its name and become a wholly-owned subsidiary of Cancer Genetics.

The transaction will position the combined company to harness the synergies between two critical modalities of drug discovery and development - advanced animal models and relevant human high-throughput organoid platforms. The resulting integration of scientific and technology-based expertise, skilled management teams, and ability to offer customers an end-to-end platform will de-risk and accelerate development of preclinical and clinical pipelines for biopharma partners as well as for the proprietary pipeline of the combined company. In combination, Cancer Genetics and StemoniX currently enjoy partnerships and R&D relationships with dozens of global pharmaceutical and biotechnology companies.

"The process of discovering and developing a new drug candidate takes years and comes with a price tag of hundreds of millions - or even billions - of dollars. However, we are at unique time in the drug discovery industry as the convergence of technological innovations in both biology and software will transform conventional workflows in time and accuracy. To convert the time-consuming and labor-intensive process of developing a drug for market, we now look to supplement traditional discovery and drug approval mechanisms to include humanized cell-based assays with artificial intelligence (AI) along with our core vivoPharm business. Given that our strategy and approach are strongly aligned with those of StemoniX, we are pleased to have moved forward with this proposed transaction," stated Jay Roberts, Chief Executive Officer of Cancer Genetics.

The pharma industry and society are at a critical pivot point. Viral pandemics and diseases lacking treatments require a new way of innovation. The proposed merger expects to expand our ability to engage with a larger audience of potential partners and expand our internal capabilities as we deliver on our mission to rapidly discover the safest and most effective therapeutics on behalf of our partners and our shareholders. The mission will stay consistent - allow scientists to quickly and economically conduct high-throughput toxicity and drug development studies in ready-to-assay plates containing functional microOrgans, stated Ping Yeh, Chief Executive Officer of StemoniX.

ABOUT THE TRANSACTION

Pursuant to the merger agreement, Cancer Genetics will acquire all of the outstanding capital stock of StemoniX in exchange for a number of shares of its common stock which will represent approximately 78% of the outstanding common stock of Cancer Genetics, subject to certain adjustments and prior to the effects of the financing referred to below, with the current equity holders of Cancer Genetics retaining 22% of the common stock immediately following the consummation of the merger.

The Boards of Directors of both companies have approved the proposed merger, which is expected to close in the fourth quarter of 2020, subject to the approval of the shareholders of both Cancer Genetics and StemoniX, financing and other customary closing conditions.

H.C. Wainwright & Co. is acting as financial advisors to the Board of Directors of Cancer Genetics, and Lowenstein Sandler is acting as its legal counsel. Northland Securities, Inc. is acting as financial advisor to the Board of Directors of StemoniX and Taft, Stettinius & Hollister is acting as its legal counsel.

ABOUT CANCER GENETICS

Through its vivoPharm subsidiary, Cancer Genetics offers proprietary preclinical test systems supporting clinical diagnostic offerings at early stages, valued by the pharmaceutical industry, biotechnology companies and academic research centers. The Company is focused on precision and translational medicine to drive drug discovery and novel therapies. vivoPharm specializes in conducting studies tailored to guide drug development, starting from compound libraries and ending with a comprehensive set of in vitro and in vivo data and reports, as needed for Investigational New Drug filings. vivoPharm operates in The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accredited and GLP compliant audited facilities. For more information, please visit http://www.cancergenetics.com.

ABOUT STEMONIX, INC.

StemoniX is empowering the discovery of new medicines through the convergence of novel human biology and software technologies. StemoniX develops and manufactures high-density, at-scale human induced pluripotent stem (iPSC) cell-derived neural and cardiac screening platforms for drug discovery and development. Predictive, accurate, and consistent, these human models enable scientists to quickly and economically conduct research with improved outcomes in a simplified workflow. Through collaborations with drug discovery organizations, StemoniX tests compounds in-house, creates new cell-based disease models, and operationalizes custom human iPSC disease models at large scale for high-throughput screening. With leading-edge iPSC technologies and data science, StemoniX is helping global institutions bring the most promising medicines to patients. To learn more about how StemoniX products and services are accelerating discoveries, please visit http://www.StemoniX.com.

For more information, please visit or follow CGI at:

http://www.cancergenetics.com

Twitter: @Cancer_Genetics

And StemoniX at:

http://www.StemoniX.com

Forward Looking Statements:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Cancer Genetics Inc.s expectations regarding satisfaction of closing conditions, consummation of the merger, future financial and/or operating results, and potential for our services, future revenues or growth in this press release constitute forward-looking statements.

Any statements that are not historical fact (including, but not limited to, statements that contain words such as will, believes, plans, anticipates, expects, estimates) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in our ability to satisfy all closing conditions to the merger, our attempts to adapt to the global coronavirus pandemic, achieve profitability by increasing sales of our pre-clinical services, maintain our existing customer base and avoid cancellation of customer contracts or discontinuance of trials, raise capital to meet our liquidity needs and conditions to the merger, properly evaluate strategic options, and other risks discussed in the Cancer Genetics, Inc. Form 10-K for the year ended December 31, 2019 and Form 10-Q for the quarter ended June 30, 2020, along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics, Inc. disclaims any obligation to update these forward-looking statements.

Investor Contacts:Jennifer K. Zimmons. Ph.D.Investor RelationsZimmons International Communications, Inc.Email: jzimmons@zimmonsic.comPhone: +1.917.214.3514

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Canada Foundation for Innovation invests $9.3M in McGill highly-specialized research infrastructures – Science Business

Posted: at 4:17 pm

Thirty-eight McGill research projects have received federal grants through the CFI's John R. Evans Leaders Fund, which will provide them with state-of-the art research infrastructure needed to foster innovation.

The Government of Canada through the Canada Foundation for Innovation (CFI) recently announced their funding investment of more than $96 million to support 377 new research infrastructure projects at 55 institutions from coast to coast. The CFI also announced the funding of projects through the John R. Evans Leaders Fund (JELF) in partnership with the Canada Research Chairs (CRC) Program, investing $4.6 million in 21 Chairs at 16 institutions to provide them with the innovative tools they need to pursue their valuable work.

Thirty-eight McGill research projects have received a combined total of $9.3M in federal grants through this round of JELF. The fund helps universities attract top talent in diverse fields of research by providing them with the highly specialized research infrastructure they need to be leaders in their field. The recipients will also receive matching funds from the Quebec government for their research endeavours.

ProfessorsJrg Hermann FritzandCorinne Mauriceof the Department of Microbiology and Immunology, andBastien Castagnerof the Department of Pharmacology and Therapeutics, received $352,778 in JELF funding for their project on harnessing microbiota metabolism for human health benefits. The project will focus on the ill-defined relationship between bacteria in the human gut, metabolism and the immune system. The research will help design new, more effective drugs to treat inflammatory bowel diseases, obesity, asthma and other chronic diseases.

One McGill project received $520,000 in JELF funding, in partnership with the Canada Research Chairs (CRC) program. ProfessorStephen Lomberof the Department of Physiology and Canada Research Chair in Brain Plasticity and Development, received $520,000 from the JELF and CRC partnership to establish an internationally recognized laboratory with state-of-the-art facilities for the study of brain plasticity and auditory neuroscience. The laboratory will help researchers understand how the brain processes sound, and how to best design therapeutic strategies for the 300,000 Canadians burdened with profound hearing loss.

McGill CRC-JELF recipient:

Hearing Loss and Restoration LaboratoryProfessorStephen Lomberof the Department of Physiology, Faculty of Medicine and Health Sciences, is the principal investigator.$520,000 from the CRC-JELF partnership; $520,000 matching provincial funds.

List of McGill JELF recipients:Creation of a Multidisciplinary Sleep Laboratory at the NeuroProfessorsJulien DoyonandBirgit Frauscherof the Department of Neurology and Neurosurgery, Faculty of Medicine and Health Sciences, are the principal investigators.$254, 296 from JELF; $254, 296 matching provincial funds.

Harnessing Microbiota Metabolism for Human Health BenefitsProfessorsJrg Hermann FritzandCorinne Mauriceof the Department of Microbiology and Immunology, andBastien Castagnerof the Department of Pharmacology and Therapeutics, Faculty of Medicine and Health Sciences, are the principal investigators.$352,778 from JELF; $352,778 matching provincial funds.

Multi-scale in Vivo Imaging of Biological SystemsProfessorAbigail Gerholdof the Department of Biology, Faculty of Science, is the principal investigator.$271,990 from JELF; $271,990 matching provincial funds.

MAP-PRO: An Electronic Database and Learning Hub for Canadian Early Psychosis ServicesProfessorsSrividya IyerandManuela Ferrariof the Department of Psychiatry, Medicine and Health Sciences, are the principal investigators.$80,000 from JELF; $80,000 matching provincial funds.

McGill Soil Biogeochemistry and Ecology LaboratoryProfessorCynthia Kallenbachof the Department of Natural Resource Sciences, Faculty of Agricultural and Environmental Sciences, is the principal investigator.$150,000 from JELF; $150,000 matching provincial funds.

Subsurface Hydrogeochemistry and Fluid FlowProfessorMary Kangof the Department of Civil Engineering and Applied Mechanics, Faculty of Engineering, is the principal investigator.$475,360 from JELF; $475,360 matching provincial funds.

Combined Microreactor Mass Spectrometry Infrastructure for Catalyst CharacterizationProfessorJan Kopyscinskiof the Department of Chemical Engineering, Faculty of Engineering, is the principal investigator.$120,000 from JELF; $120,000 matching provincial funds.

Fast Scalable Deep Learning for Sensitive Big Data in Healthcare and Social ContextsProfessorsYue Li,William HamiltonandReihaneh Rabbanyof the School of Computer Science, Faculty of Science, are the principal investigators.$120,000 from JELF; $120,000 matching provincial funds.

Click Chemistry for Precision MedicineProfessorNathan Luedtkeof the Department of Chemistry, Faculty of Science, is the principal investigator.$285,000 from JELF; $285,000 matching provincial funds.

Conformational Dynamics of Complex Proteins in Health and DiseasesProfessorGergely Lukacsof the Department of Physiology, ProfessorKalle Gehringof the Department of Biochemistry, andJean-Francois Trempeof the Department of Pharmacology and Therapeutics, Faculty of Medicine and Health Sciences, are the principal investigators.$592,636 from JELF; $592,636 matching provincial funds.

Antagonistic Inter-bacterial InteractionsProfessorJennifer Ronholmof the Department of Food Science and Agricultural Chemistry, Faculty of Agricultural and Environmental Sciences, is the principal investigator.$143,180 from JELF; $143,180 matching provincial funds.

Blood-based Biomarkers for Ageing-related Brain DiseasesProfessorsPedro Rosa-Netoof the Department of Psychiatry,Gerhard Multhaupof the Department of Pharmacology and Therapeutics, andAngela Gengeof the Department of Neurology and Neurosurgery, are the principal investigators.$417,175 from JELF; $417,175 matching provincial funds.

Infrastructure for Advanced Arctic and Urban Climate Modelling in Support of Climate-resilient Engineering SystemsProfessorLaxmi Sushamaof the Department of Civil Engineering and Applied Mechanics, Faculty of Engineering, is the principal investigator.$135,180 from JELF; $135,180 matching provincial funds.

CoDEx: Computational Design ExploratoryProfessorTheodora Vardouliof the Peter Guo-hua Fu School of Architecture, Faculty of Engineering, is the principal investigator.$78,807 from JELF; $78,807 matching provincial funds.

Metabolism of Stress-regulated Genes in Health and Disease using Single Molecule ImagingProfessorMaria Vera Ugaldeof the Department of Biochemistry, Faculty of Medicine, is the principal investigator.$200,000 from JELF; $200,000 matching provincial funds.

Drivers of Breast Cancer Progression Identified within Arm-level Somatic Copy Number AlterationsProfessorLogan Walshof the Department of Human Genetics, Faculty of Medicine and Health Sciences, is the principal investigator.$109,179 from JELF; $109,179 matching provincial funds.

Development of Biodegradable Functional Materials from Low-value Biomass for Food and Agricultural ApplicationsProfessorYixiang Wangof the Department of Food Science and Agricultural Chemistry, Faculty of Agricultural and Environmental Sciences, is the principal investigator.$121,500 from JELF; $121,500 matching provincial funds.

The Role of Lipoma Preferred Partner (LPP) in Regulating Breast Cancer ProgressionProfessorsClaire Brownof the Department of Physiology andPeter Siegelof the Departments of Medicine, Biochemistry, and Anatomy and Cell Biology, Faculty of Medicine and Health Sciences, are the principal investigators.$744,304 from JELF; $744,304 matching provincial funds.

Muscle Stem Cell Biology in Health and DiseaseProfessorNatasha Changof the Department of Biochemistry, Faculty of Medicine and Health Sciences, is the principal investigator.$149,582 from JELF; $149,582 matching provincial funds.

NIR Imaging Platform for Biophotonic Technologies Relying on New Dormant Sensors/SensitizersProfessorGonzalo Cosaof the Department of Chemistry, Faculty of Science, is the principal investigator.$172,875 from JELF; $172,875 matching provincial funds.

A Path to Anti-aging DrugsProfessorSiegfried Hekimiof the Department of Biology, Faculty of Science, is the principal investigator.$179,196 from JELF; $179,196 matching provincial funds.

Markers to Market: A Platform to Translate Quantitative Genomics Data into Field-ready, Value-added Commodity CultivarsProfessorValerio Hoyos-Villegasof the Department of Plant Science, Faculty of Agricultural and Environmental Sciences, is the principal investigator.$152,062 from JELF; $152,062 matching provincial funds.

Mechanism and Therapy for Autism Spectrum Disorders Associated with Copy Number VariantsProfessorWei-Hsiang Huangof the Department of Neurology and Neurosurgery, Faculty of Medicine and Health Sciences, is the principal investigator.$169,634 from JELF; $169,634 matching provincial funds.

Development of Strategies to Better Understand and Control the Long-term Side Effects of RadiotherapyProfessorJohn Kildeaof the Department of Oncology, Faculty of Medicine and Health Sciences, is the principal investigator.$87,579 from JELF; $87,579 matching provincial funds.

4D Immersive Scene Capture and ProcessingProfessorDerek Nowrouzezahraiof the Department of Electrical and Computer Engineering, Faculty of Engineering, is the principal investigator.$78,020 from JELF; $78,020 matching provincial funds.

Mapping Dopamine Circuits in the Healthy and Diseased BrainProfessorJean-Francois Poulinof the Department of Neurology and Neurosurgery, Faculty of Medicine and Health Sciences, is the principal investigator.$294,592 from JELF; $294,592 matching provincial funds.

UHPLC-MS to Develop Technologies to Control the Presence and Fate of Contaminants in Natural & Engineered Water SystemsProfessorViviane Yargeauof the Department of Chemical Engineering, Faculty of Engineering, is the principal investigator.$406,300 from JELF; $406,300 matching provincial funds.

Integrated Facility for Research on Large Animals SpeciesProfessorsVilceu Bordignonof the Department of Animal Science andLuis B Agellon, of the Department of School of Human Nutrition, Faculty of Agricultural and Environmental Sciences, are the principal investigators.$800,000 from JELF; $800,000 matching provincial funds.

Exercise and Nutrition to Support Skeletal Muscle Heath Across the LifespanProfessorTyler Churchward-Venneof the Department of Kinesiology and Physical Education, Faculty of Education, is the principal investigators.$344,957 from JELF; $344,957 matching provincial funds.

Neuroecology of Spatial Behaviour LabProfessorMlanie Guiguenoof the Department of Biology, Faculty of Science, is the principal investigator.$165,000 from JELF; $165,000 matching provincial funds.

Biotechnological Production of High-value CompoundsProfessorCodruta Igneaof the Department of Bioengineering, Faculty of Engineering, is the principal investigator.$140,000 from JELF; $140,000 matching provincial funds.

Atomic Layer Deposition of Electrochemical Energy Storage DevicesProfessorEmmeline Kaoof the Department of Mechanical Engineering, Faculty of Engineering, is the principal investigator.$260,101 from JELF; $260,101 matching provincial funds.

High Throughput Monitoring of Cell Metabolism using a Modernized Tissue Culture FacilityProfessorRyan Maillouxof the School of Human Nutrition, Faculty of Agricultural and Environmental Sciences, is the principal investigator.$234,500 from JELF; $234,500 matching provincial funds.

Anishinaabe Stories DatabaseProfessorAaron Millsof the Faculty of Law, is the principal investigator.$46,961 from JELF; $46,961 matching provincial funds.

New Computational Techniques for Modeling of Disordered Molecular Systems for Applications in Nano- and Bio- engineeringProfessorYelena Simineof the Department of Chemistry, Faculty of Science, is the principal investigator.$80,000 from JELF; $80,000 matching provincial funds.

Circulating Immune Cells and Interactions in the Nervous SystemProfessorJo Anne Strattonof the Department of Neurology and Neurosurgery, Faculty of Medicine and Health Sciences, is the principal investigator.$141,863 from JELF; $141,863 matching provincial funds.

Heat Transfer in Thermal Energy TechnologiesProfessorMlanie Ttreault-Friendof the Department of Mechanical Engineering, Faculty of Engineering, is the principal investigator.$233,308 from JELF; $233,308 matching provincial funds.

Read CFIs official press release.

This article was first published on 25 August by McGill University.

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Canada Foundation for Innovation invests $9.3M in McGill highly-specialized research infrastructures - Science Business

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NeuBase Therapeutic’s CEO, Dietrich A. Stephan, Ph.D., to Present at Tribe Public’s Presentation and Q&A Webinar Event on August 26, 2020 – Stockhouse

Posted: at 4:17 pm

SAN FRANCISCO, CA / ACCESSWIRE / August 24, 2020 / Tribe Public announced today that Dietrich Stephan, Chief Executive Officer of NeuBase Therapeutics, Inc. (NASDAQ:NBSE), a biotechnology company developing next-generation antisense oligonucleotide (ASO) therapies using its scalable PATrOL platform to address genetic diseases, will present at Tribe Public's Presentation and Q&A Webinar Event at 8 am pacific/11 am eastern on Wednesday, August 26th, 2020. During this complimentary, 30-minute event, Dr. Stephan will introduce the NeuBase's next-generation gene silencing technology and discuss the company's progress with treatment candidates in Huntington's Disease (HD) and Myotonic Dystrophy (DM1). A question and answer session will follow the presentation. To register to join the complimentary event, please visit the Tribe Public LLC website: http://www.tribepublic.com, or send a message to Tribe's management at research@tribepublic.com to request your seat for this limited capacity Zoom-based event.

Dietrich A. Stephan, Ph.D. is an industry veteran who is considered one of the fathers of the field of precision medicine, having trained with the leadership of the Human Genome Project at the NIH and then going on to lead discovery research at the Translational Genomics Research Institute and serve as professor and chairman of the Department of Human Genetics at the University of Pittsburgh. Dr. Stephan has identified the molecular basis of dozens of genetic diseases and published extensively in journals such as Science, the New England Journal of Medicine, Nature Genetics, PNAS, and Cell. In parallel, Dr. Stephan has founded or co-founded more than ten biotechnology companies and has advised numerous other companies. These companies are backed by top-tier investors such as Sequoia Capital, KPCB, Thiel Capital, and Khosla Ventures as well as corporate partners such as Life Technologies, Pfizer, and Mayo Clinic. Notably, Dr. Stephan founded NeuBase Therapeutics in August 2018, took it public in 2019, and has since grown the company to market capitalization to the tune of hundreds of millions of dollars. Dr. Stephan received his Ph.D. from the University of Pittsburgh and his B.S. from Carnegie Mellon University.

ABOUT TRIBE PUBLIC LLC Tribe Public LLC is a San Francisco, CA-based organization that hosts complimentary worldwide webinar & meeting events in the U.S. Tribe's events focus on issues that the Tribe members care about with an emphasis on hosting management teams from publicly traded companies from all sectors & financial organizations that are seeking to increase awareness of their products, progress, and plans. Tribe members primarily include Institutions, Family Offices, Portfolio Managers, Registered Investment Advisors, & Accredited Investors. Website: http://www.tribepublic.com.

ABOUT NEUBASE THERAPEUTICS NeuBase Therapeutics, Inc. is developing the next generation of gene silencing therapies with its flexible, highly specific synthetic antisense oligonucleotides. The proprietary NeuBase peptide-nucleic acid (PNA) antisense oligonucleotide (PATrOL) platform allows for the rapid development of targeted drugs, increasing the treatment opportunities for the hundreds of millions of people affected by rare genetic diseases, including those that can only be treated through accessing of secondary RNA structures. Using PATrOL technology, NeuBase aims to first tackle rare, genetic neurological disorders. NeuBase is continuing its progress towards developing treatment candidates in Huntington's Disease (HD) and Myotonic Dystrophy (DM1.)

CONTACT:

Tribe Public, LLC. John F. Heerdink, Jr. Managing Partner john@tribepublic.com

SOURCE: NeuBase Therapeutics, Inc.

View source version on accesswire.com: https://www.accesswire.com/603092/NeuBase-Therapeutics-CEO-Dietrich-A-Stephan-PhD-to-Present-at-Tribe-Publics-Presentation-and-QA-Webinar-Event-on-August-26-2020

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NeuBase Therapeutic's CEO, Dietrich A. Stephan, Ph.D., to Present at Tribe Public's Presentation and Q&A Webinar Event on August 26, 2020 - Stockhouse

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Three lessons from the Federal Circuit’s recent 101 reversal in XY v Trans Ova Genetics – IAM

Posted: at 4:17 pm

The Federal Circuit has issued a precedential decision in XY LLC v Trans Ova Genetics. Judge Stoll, joined by Judge Wallach and Senior Judge Plager, held that claims directed to a specific improvement to an otherwise-known process are patent eligible under 35 USC section 101. In reversing the district court, the court held that, although the invention applies mathematical equations to effect the claimed improvement, the claims were directed to a specific improvement that separates the invention from the prior art - not to an abstract idea.

The courts decision details several principles underlying the section 101 analysis and offers lessons for litigants addressing eligibility determinations.

XYs 559 patent involves flow cytometry technology for sorting non-human mammalian particles. This technology is particularly useful in animal breeding to guarantee the sex of offspring, allowing sperm cells to be sorted based on whether the cell carries an X or Y chromosome. While conventional flow cytometry technology made it difficult to discriminate between similar particles of different populations, the 559 patent claims an improvement that uses mathematical equations to reconfigure data corresponding to the particles, such as by rotating it, in order to increase spatial separation of data points and make it possible to discriminate between particles. XYs improved methods allow populations to be selected more accurately than in any other prior art system.

The district court decided the 559 patent claims were invalid under section 101. Starting with Alice step one, the court found the claims were directed to the abstract idea of a mathematical equation that permits rotating multi-dimensional data. It reasoned that, although the equation helps to discriminate between particles of different populations, the invention reduces down to applying a mathematical concept. Then, at Alice Step Two, the court held the asserted claims lack an inventive concept because it believed the claims offer nothing beyond the prior art.

Reversing the district court, the Federal Circuit decided on 31st July that the 559 patent claims are directed to a specific improvement to a flow cytometry method, not an abstract idea. Specifically, the court held the claims are directed to an improved method for classifying and sorting particles based on the specific steps set forth in the claims, thereby facilitating classification and sorting of each individual particle more accurately than any prior art method. Although the patent used mathematical equations to implement the improvement, the court found the claims were directed to an improvement to the method itself that so happened to use math. Because the court held that the claims are not directed to an abstract idea at Alice step one, it did not move on to step two.

The courts decision and its section 101 analysis offers several valuable lessons for litigants:

This pattern underscores the need for both patentees and challengers to make their case at Step One. Is it an improvement to an existing technology that so happens to use an abstract idea to implement that improvement, or are the claims directed to an improvement to the abstract idea itself? In XY, the invention improved a known flow cytometry process by applying a mathematical formula. While the court held that claimed improvement passed the Alice test, a claim directed to improving the mathematical formula by itself would likely not be eligible. XY makes clear that it is critical for patentees and challengers alike to define what the claims are directed to, knowing that step one is likely going to make or break the section 101 decision.

It is therefore critical for litigants to articulate, at Step One, what solutions existed in the prior art and why (or why not) the claims represent an improvement to those solutions. XY confirms the courts holding in Thales Visionix v United States that improving the accuracy of a prior art solution can be enough to make the claims a patentable improvement. Moreover, if a party can tie the claimed improvement to a physical process or product, all the better. The XY court found important the fact that the claimed method resulted in separation of physical particles, like the claimed improvement in Diamond v Diehr produced a perfectly-cured synthetic rubber product.

The Federal Circuits decision in XY confirms that claimed improvements to the prior art can be patent-eligible, even if the claims use an abstract idea such as a mathematical formula to execute the improvement. Litigants addressing section 101 challenges should focus on articulating what the claimed invention is, how it relates to the prior art, and how the claims compare to others that courts have already held to be eligible, or ineligible, under section 101.

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