Daily Archives: November 13, 2019

Foodborne illnesses are not only an unpleasant personal experience for millions of Americans each year, theyre a logistical concern for businesses, with the potential to drive and keep people (and their dollars) away for good. As our food supply becomes increasingly global, the ability to accurately and quickly identify the source of any pathogen causing a foodborne illness has become exponentially more difficult. To ensure the safety of what we eat, the Food and Drug Administration (FDA) plans to build upon its early success with digital technology and whole-genome sequencing for its New Era of Smarter Food Safety.

Whole-genome sequencing

At its simplest, a genome is the information a cell needs to create an organism. Since an organisms genome is as unique as a fingerprint, sequencing that genome is the first step in being able to quickly identify just what is making a person sick. Scientists generate the sequence by gathering samples of a particular food in a sterile environment, mashing it up, and conducting the genome analysis. The result is the fingerprint for that specific entity.

The problem is, having this information on hand at the local level is useful only under very limited circumstances. For instance, it would be enough if a group of people became ill after eating a single meal with food sourced locally, in a single sitting at a single event. With a few calls, it might be possible to identify the food causing the illness and take steps to keep it from being shipped to new locations.

More common is the case in which a number of people with nothing in common at first become ill within days of one another. Making a match between the pathogen causing the illness and the pathogen in each food involved is still fairly straightforward if everything is sourced locally. But what if some of the food comes from sources across the globe? How are the fingerprints for those foods going to be of use in stopping the spread of the illness to additional locations when there is no way to readily communicate with other localities?

GenomeTrakr

So, to bring whole-genome information into play on a global scale, the FDA created a United States-based open-source distributed network of labs in 2013. The result is GenomeTrakr the stuff of foodie-sci-fi. It makes whole-genome sequences from foods around the world available globally. Any health agency, anywhere on the network, can upload data from a pathogen causing illness in their locality and receive information about entities that match or closely approximate that sequence. In effect, the power of the digital fingerprinting and related DNA sampling now in use in law enforcement can be put to work for foodborne illness outbreaks by either making a match or reporting that the match is likely to be found within a certain cluster of related genome sequences. This game-changing use of whole-genome sequencing has already helped to halt the spread of global foodborne pathogens several times.

A digital framework

But global genome sequencing is still not all that is needed to safeguard the food supply and your health. Being able to readily access a whole-genome sequence can tell you which food is the culprit, but how do you know where the food originated, what path it took from field to plate, and where any additional product is currently located on its journey from field to plate?

The FDAs remedy to this part of the challenge is to digitize the records kept at each step of a foods journey through the global system. Rather than filling out a paper form that remains local or creating a paper-based dossier that travels with a food shipment, each step along the way will be documented in a globally accessible, digital format. The result will be a system that complements the GenomeTrakr by making it possible to trace the source of a foodborne pathogen to its point of origin in minutes rather than weeks or months.

Why does it matter? It matters because ready access to the genome, the origin, and the trail it traveled will make it possible to stop the flow of this food through the system: It will keep additional people from becoming ill.

A blueprint

As the first step in the FDAs Strategic Blueprint for this New Era of Smarter Food Safety, agencies and companies from all parts of the food sector met in October to discuss the logistics of the new approach and offer input. Considerations ranging from ownership of the data to concerns about data transfer were among the many raised. These issues are not not only vital to the integrity of the data in the system, but will also result in a system we can count on when we sit down to eat.

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When it Comes to Identifying the Source of Foodborne Illness, The Future is Now - The Spoon

Anxious couples are approaching fertility doctors in the US with requests for a hotly debated new genetic test being called 23andMe, but on embryos.

The baby-picking test is being offered by a New Jersey startup company, Genomic Prediction, whose plans we first reported on two years ago.

The company says it can use DNA measurements to predict which embryos from an IVF procedure are least likely to end up with any of 11 different common diseases. In the next few weeks it's set to release case studies on its first clients.

Handed report cards on a batch of frozen embryos, parents can use the test results to try to choose the healthiest ones. The grades include risk estimates for diabetes, heart attacks, and five types of cancer.

According to flyers distributed by the company, it will also warn clients about any embryo predicted to become a person who is among the shortest 2% of the population, or who is in the lowest 2% in intelligence.

The test is straight out of the science fiction film Gattaca, a movie thats one of the inspirations of the startups CEO, Laurent Tellier. The companys other cofounders are testing expert Nathan Treff and Stephen Hsu, a Michigan State University administrator and media pundit.

So far, fertility centers have not leaped at the chance to offer the test, which is new and unproven. Instead, prospective parents are learning about the designer baby reports through word of mouth or news articles and taking the companys flyer to their doctors.

One such couple recently turned up at New York Universitys fertility center in Manhattan, says David Keefe, who is chairman of obstetrics and gynecology there. Right off the bat it raises all kind of questions about eugenics, he says.

Keefe, who has seven children, worries that couples who think they can choose kids from a menu could be disappointed. Its fraught with parenting issues, he says. So many couples just need to feel they have done enough.

Picking your baby

The companys project remains at a preliminary stage. While some embryos have been tested by the company, Tellier, the CEO, says he is unsure if any have yet been used to initiate a pregnancy.

The test is carried out on a few cells plucked from a days-old IVF embryo. Then Genomic Prediction measures its DNA at several hundred thousand genetic positions, from which it says it can create a statistical estimate, called a polygenic score, of the chance of disease later in life.

Genomic prediction

In October, the company pitched the test, which it calls LifeView, from a trade-show booth at the annual meeting of fertility doctors in Philadelphia. A promotional banner read: She has your partners ears and smile. Just not their risk of diabetes.

Criticism of the company from some genetics researchers has been intense.

It is irresponsible to suggest that the science is at the point where we could reliably predict which embryo to select to minimize the risk of disease. The science simply isnt there yet, says Graham Coop, a geneticist at the University of California, Davis, and a frequent critic of the company on Twitter.

The company has raised several million dollars in venture capital from investors including People Fund, Arab Angel, Passport Capital, and Sam Altman, the chairman of Y Combinator and CEO of OpenAI.

At an investor event last April, Genomic Prediction compared itself to 23andMe for IVF clinics and boasted it was preparing for a massive marketing push.

Our reporting suggests the company has struggled both to validate its predictions and to interest fertility centers in them. Its customers so far seem to be a scattering of individuals from around the world with specific family health worries. The company declined to name them, citing confidentiality.

The company is expected to soon present its first case reports, describing clients and their embryo test results. One case involves a married gay couple who have begun IVF using donor eggs and plan to employ a surrogate mother. That couple wants a child with a low risk for breast cancer.

How will it be used?

Genomic Prediction thinks it can piggyback on the most common type of preimplantation embryo test, which screens days-old embryos for major chromosome abnormalities, called aneuploidies. Such testing has become widespread in fertility centers for older mothers and is already employed in nearly a third of IVF attempts in the US. The new predictions could be added to it.

Fertility centers can also order tests for specific genetic diseases, such as cystic fibrosis, where a gene measurement will give a definite diagnosis of what embryo inherited the problem The new polygenic tests are more like forecasts, estimating risk for common diseases on the basis of variations in hundreds or thousands of genes, each with a small effect.

In a legal disclaimer, the company says it cant guarantee anything about the resulting child and that the assessment is NOT a diagnostic test.

Santiago Munne, an embryo testing expert and entrepreneur, thinks patients already undergoing aneuploidy testing would likely want the add-on test, but that doctors could object if it introduces uncertainty: For monogenic disease, if the embryo is abnormal, we will tell you, and it is. With a risk score, it may be affected. And some patients will only have embryos with higher risks. Then what?

As well, he says it wont be possible with a test to optimize a child for many features at once: My personal opinion is once you start looking, some embryos will be brighter, some will be taller, some will have longevity, and none will have those qualities all together. And in an IVF cycle, you produce maybe six embryos on average. You wont be able to get all the traits that you want.

Despite such inherent limits, theres a bigger plan afoot. Treff, the startup's chief scientist, believes even fertile couples might begin to undergo IVF just so they can select the best child. I do believe this is going to be the future we can start to ... reduce the incidence of disease in humans through IVF, Treff told an audience at a conference in China last month.

How many people will be willing to go through the trouble of IVF if they dont need it to have a baby? IVF involves weeks of hormone shots and two medical procedures (one to collect eggs, another to implant the embryos) and typically costs around $15,000. Add to that the companys fee to test embryos, which is $1,000, plus $400 for each embryo scored.

If someone is fertile, unless there is a family history of disease, I dont think that it is going to be popular, says Munne.

Can you get a smarter baby?

Genomic Prediction has so far won the most attention for the possibility of using genetic scores to pick the most intelligent children from a petri dish. It has tried to distance itself from the controversial concept, but thats been difficult because Hsu, a cofounder, is frequently in the media discussing the idea.

Hsu told The Guardian this year that accurate IQ predictors will be possible if not in the next five years, the next 10 years certainly. He says other countries, or the ultra-wealthy, might be the first to try to boost IQ in their kids this way.

During his talk in China, Treff called improving intelligence via embryo selection an application that many people think is unethical." In private, Treff tells other scientists he thinks it's doable, but wants to promote the technology for medical purposes only.

Ms Tech

For now, the company is limiting itself to alerting parents to embryos it predicts will be the least intelligent, with the highest chance of an IQ which qualifies as intellectual disability according to psychiatric manuals.

Some experts see a transparent maneuver to avoid controversy. They say theyre going to test for the medical condition of intellectual disability, not for the smartest embryos, because they know people are going to object to that, says Laura Hercher, who trains genetic counselors at Sarah Lawrence College. They are trying to slide, slide into traits without admitting as much.

A May report from the Hebrew University of Jerusalem found that trying to pick the tallest or smartest embryos might not work particularly well. Researchers there estimated that using polygenic scores to locate the tallest or smartest child from a batch of sibling embryos would result in an average gain of 2.5 centimeters in height, and less than three IQ points.

They modeled what everyone is scared of happening, Treff said of that study. Its not what we are doing.

The predictions, however, could be more effective at helping people avoid children with specific diseases. Treff, during his speech in China, said that a couple choosing between two embryos would see, on average, a 45% reduction in risk for type 1 diabetes. That is a serious disease from which Treff suffers and which runs in families, although it has complex causes. The more embryos there are to choose from, he says, the more the risk will go down.

Demand for the test

Patients and doctors are mostly on their own when it comes to deciding if the tests really work. While federal and state agencies do oversee laboratory accuracy, the oversight is limited to whether analytes like DNA are correctly measured, not what they mean. So Genomic Prediction doesnt need to prove that the test is useful before selling it. In fact, it could take decades to ascertain if tested kids fare better than others.

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And its not only whether the test works or not. Uptake will depend on demand from patients and the degree of pushback from doctors and genetic counselors. In the US, tests for genderthat is, picking a boy or a girl embryoare accepted and relatively routine. But thats never become the case for choosing eye color, which is also possible. In terms of eye color, the pressure not to do it, to not offer it, was met with a weak market demand. So it doesnt exist, says Hercher.

Genomic Prediction provided a map of 12 fertility clinics it says will order its test, including five in the US and others in Nigeria, Peru, Thailand, and Taiwan.

MIT Technology Review was able to independently locate two IVF clinics where customers have recently requested the embryo predictions. Michael Alper, founder of Boston IVF, one of the worlds largest fertility clinics, says his center was approached by a couple a few weeks ago but he decided the request needs to be weighed by the centers ethics committee before he would agree to order it.

This is the first case we have had, says Alper. To me its a 23andMe type of prediction: theres a propensity, but how strong? That is the problem. We dont have any problem testing for cystic fibrosisthat is a lethal disease, it strikes young. But we are not there yet with these other tests. Its soft; its not that predictive.

At NYU, Keefe says the test raises profound questions. His center is in Midtown Manhattan, just blocks from a hub of finance and legal offices. He says his clientele are typically well-off professionals, people who have programmed everything in life and feel they are in control. They sometimes even ask out loud if a mere doctor is smart enough to help them.

The case he is working on involves a family that has two children with autism. They now want a child without the condition, and they hope the intelligence feature of the test will help them. Treff says he counseled the family that the Genomic Prediction test wasnt likely to helpautism can have specific genetic causes that the intelligence prediction isnt designed to capture.

Yet the family remains interested. They want to do whatever they can to have a healthy kid. Keefe says hes so far supporting their choice, but he is concerned by all that it implies. There is potential psychological harm to the kid, he says. God forbid the kids ends up with autism after spending this money.

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The world's first Gattaca baby tests are finally here - MIT Technology Review

11 November 2019

Twenty thousand babies are to have their genomes sequenced at birth in an NHS-based pilot announced by Matt Hancock on Monday 4 November at the Genomics England Research Conference.

The announcement by the Secretary of State for Health and Social Care did not receive the fanfare or focus it deserved. There has not been a press release from the Department of Health and Social Care, and it was only picked up by the papers on Wednesday 6 November, just before the government and the civil service entered the pre-election purdah period.

The Sun, and the Times welcomed the news, sharing that 'around 3000 of the 660,000 babies born a year in England and Wales are thought to have a treatable, early-onset disease', while other coverage (Futurism, New Scientist)raised ethical challenges and privacy concerns.

It is not hyperbole to state that England will shortly lead the world in genomic diagnosis. The new NHS England Genomic Medicine service will offer all acutely ill children with a likely monogenic condition, and all children with cancer, a whole-genome sequence. The list of diagnostic grade genes on Genomics England's curated PanelApp which allows experts to review genes and the evidence for their relation to conditions, was at 3139 in August 2019 at PanelApp's fourth birthday, with 56,640 gene-disease curations.

In the UK we are in an unusual position. We are at the forefront of diagnosing people with rare diseases but are among the countries screening for fewest rare conditions at birth (see BioNews 1008). The announced pilot offers one route to bridge this disparity. We are behind most countries in Europe and other high-income countries when it comes to identification of babies at risk of genetic conditions at birth.

The UK National Screening Committee currently recommends that the NHS screens for nine conditions at birth few enough to list here: phenylketonuria (first screened for in 1969), congenital hypothyroidism (1981), sickle cell disease (2006), cystic fibrosis (1983 in Northern Ireland, 1997 in Wales, 2003 in Scotland and 2007 in England), and four further metabolic conditions: medium-chain acyl-CoA dehydrogenase deficiency, maple syrup urine disease, isovaleric acidaemia, glutaric aciduria type 1 and homocystinuria (all began in 2015 in England and Wales, and 2017 in Scotland, with no screening in Northern Ireland).

For comparison, Italy screens for 43 conditions, the Netherlands 34, Australia 28, the Czech Republic 20, while Spain screens for seven, Ireland six, and France five.

Diagnosis of symptomatic individuals and screening at birth are two different things: clinical diagnoses are performed with a combination of genomic information from testing and phenotypic information from consultation and a screening approach is clearly not appropriate for all conditions listed in PanelApp. While the disparity between the UK's adoption of each is so great, it can appear to our community that the NHS is waiting for children to get ill instead of intervening sooner.

The benefits of diagnosis to families affected by rare conditions are accepted, but the benefits of screening to identify these families in advance of symptoms developing are ignored. For the affected child, screening can prevent a future lengthy diagnostic odyssey, provide access to treatments that are best delivered before symptoms develop, enable participation in clinical trials and ensure the best possible quality of life by beginning care pathways at the optimum moment.

To the family, screening can identify a risk to future births and enable reproductive decision-making, as well as giving time to prepare for the expected condition. More broadly, newborn screening can improve our knowledge of the incidence and nature of rare conditions and enable research.

In July 2019, Genetic Alliance UK launched our Patient Charter on Newborn Screening: Fixing the Present, Building for the Future. Our community recommended that a pilot of newborn screening using genome sequencing should go ahead as soon as possible for the key reason that the number of conditions that can be identified is much greater than when using traditional metabolic screening technology, which relies on early metabolic indications of the condition. Genomic screening can identify future risk before there are any symptoms. The US-based research project BabySeq labelled 885 gene-disease pairs as having 'definitive or strong evidence to cause a highly penetrant childhood-onset disorder'.

The community also identified the challenges that must be addressed in a pilot. Some of these were picked up in concerns aired in reporting of the announcement. Futurist raised that: 'It would also mean that kids' entire genetic sequence will be mapped out long before they can understand what that means or agree to having it done. As genomic science develops, dilemmas about personal privacy and what happens to the data after its collected are still far from being sorted out.'

Our workshop participants noted that we 'are struggling to adequately inform patients and families about the screening done now within the NHS' but felt that 'we should press on, but recognise that communication and standards need to improve'.

The concern about children's health data being examined before they gain the capacity to understand the implications was one of the many concerns around this initiative that have already been dealt with in some form. Parental choice and how it affects children as they grow up is not a new issue, and the approaches taken to explore this question in the past will be applicable to this pilot.

New Scientist's coverage focused on the challenge of dealing with a screening result for a late-onset condition, which raises the question as to which conditions should be screened for and how they should be selected. Again, this is a question that has been solved before in a different context. The means by which the 100,000 Genomes Project identified whether to report findings and which additional findings to offer can be adapted to address this question.

Other familiar questions will need to be examined again from a different perspective: how to manage a parallel health and research consenting process, the ethics of storing genome sequences, and how genetic information will be shared within families.

New questions that need to be addressed in the pilot include where this methodology fits alongside the current newborn screening programme, and whether this approach is a good use of NHS resources.

The key element of what little we know about this initiative so far is that it is a pilot. Genomics has vast potential to deliver benefit to the currently undeserved community of people living with rare, genetic and undiagnosed conditions. We need to take every opportunity to find answers to the challenges instead of letting them hold us back.

Link:
Let's grasp this opportunity to examine the potential future of screening - BioNews

New technology reduces amount of time spent preparing treatment plans in cancer genomic medicine by half in verification trials conducted with the Department of Hematology and Oncology

KAWASAKI, Japan, Nov 7, 2019 - (JCN Newswire) - Fujitsu has announced the results of a joint research project it has been conducting with the Institute of Medical Science at the University of Tokyo since April 2018. As part of this joint research, Fujitsu Laboratories Ltd. has successfully developed and verified AI technology to improve the efficiency of treatment planning in cancer genomic medicine, demonstrating its effectiveness through verification experiments at the Institute of Medical Science at the University of Tokyo.

In the field of cancer genomic medicine, creating treatment plans derived from genomic information remains a costly and time-consuming process. The newly developed technology extracts from a vast body of research and academic papers to generate a knowledge graph of cancer genomic medicine that can be used for creating treatment plans, including the effects of a given course of treatment. Verification trial experiments using this technology have allowed the Department of Hematology and Oncology at the Institute of Medical Science, the University of Tokyo to reduce the amount of work required to determine a treatment plan for acute myeloid leukemia by more than half, delivering improved efficiency.

Moving forward, Fujitsu Laboratories will support the work of medical doctors by expanding the technology to deal with a greater range of cancer types and contribute to the overall advancement of cancer genomic medicine.

The technology will be on display at "Fujitsu Forum Munich 2019" in Munich, Germany, from Wednesday, November 6.

Development Background

The goal of cancer genomic medicine is to provide optimal medical care for each patient by identifying genomic mutations in cancer patients and predicting the likelihood of disease, as well as drug response and side effects. Starting from June 2019 in Japan, cancer gene panel testing has been covered by health insurance, and industry experts anticipate an increasing number of patients to seek further testing.

Presently, in the field of cancer genomic medicine, it remains necessary for specialist physicians to painstakingly search for relevant articles one by one from a database and determine appropriate treatment methods as well as their effects on the patient (Figure 1). To address these challenges, Fujitsu Laboratories and the Institute of Medical Science at the University of Tokyo's launched a joint AI research project beginning in April 2018 to improve the efficiency and sophistication of the work of physicians specializing in cancer genomics, subsequently conducting a verification trial for the technology.

Outline of the Verification Trials

1. Trial PeriodJuly 2018 to September 2019

2. Trial LocationDepartment of Hematology and Oncology, the Institute of Medical Science at the University of Tokyo

3. Developed technologyThe new technology automatically generates a database of knowledge on the relationship between gene mutations and therapeutic drugs, and the relationship between therapeutic drugs and their effects, drawing from medical papers. This is accomplished by integrating Fujitsu's AI technology for language processing, which identifies terms and phrases used in research papers from context, as well as insight of information needed to discuss treatment policies identified by the Institute of Medical Science at the University of Tokyo.

4. Verification Trial DetailsWith the newly developed technology, 2.4 million elements of relationships from 860,000 medical papers are automatically extracted as knowledge to construct a knowledge graph database for cancer genomic medicine.

In this study, the time required for 4 physicians specializing in hematological malignancies at the Institute of Medical Science at the University of Tokyo to search and examine papers using the technology based on past cases of acute myeloid leukemia is measured, and the efficiency of examination work with and without the newly developed technology is evaluated(1) (Fig. 2). For this verification experiment, a database developed by Fujitsu Limited in cooperation with the Japan Agency for Medical Research and Development as part of the "Program for an Integrated Database of Clinical and Genomic Information"(2) is used as part of the knowledge graph.

5. ResultsThe technology reduced the burden of reading the entire paper by presenting the knowledge extracted from each paper and enabled users to focus on pertinent aspects of research alone. As a result, it was confirmed that the new technology can reduce the amount of time spent on this task by more than half, compared with the average of about 30 minutes per each study it took in the past. At present, it is estimated that more than 12,000 people suffer from leukemia annually in Japan(3), and if genomic medical treatments are administered to all of them using this new technology, the 6,000 hours of examination work normally required for experts can be shortened to 3,000 hours or less, considerably expediting the process of determining the a treatment appropriate for each patient.

Future Plans

Technology developed at Fujitsu Laboratories to explain the reason and rationale behind AI decision-making(4) is to be used in conjunction with this technology in order to further improve the efficiency of the genomic mutation curation process. Fujitsu will further use the knowledge graph for precision medicine developed through this joint research to improve the efficiency of the study of gene mutations for a wide range of cancer types, and actively promote the development of cancer genomics in clinical practice.

Comment from our Research Partners

Professor Seiya Imoto, Health Intelligence Center, the Institute of Medical Science at the University of Tokyo

"The promise of new genomic medicine, which harness the wealth of information contained in the human genome, remains extremely difficult to fully exploit given the limited time of doctors. This trial demonstrates that AI technology can be used to support planning for treatments that target blood tumors, helping physicians to process the research literature that forms the basis of therapeutic best practices in less than half the time it has previously taken. We hope that the further development of AI technology for various genome-related medical contexts will enable more patients to receive precision medicine, contributing to the realization of medical care in Japan that can beat cancer."

(1) The efficiency of examination work with and without the newly developed technology is evaluatedIn the actual verification work, apart from searching relevant research papers, doctors engage in various additional work, such as interpreting sequence data, analyzing data, and creating reports.(2) The Japan Agency for Medical Research and Development as part of the "Program for an Integrated Database of Clinical and Genomic Information"A program based on the interim report of the Council for Promotion of Genome Medicine Implementation, to verify the relationship between genome information and disease specificity and clinical characteristics, to develop a database that comprehensively handles clinical information and genomic information that can be used for clinical and research purposes, and to promote advanced research and development that makes use of the research infrastructure.(3) At present, it is estimated that more than 12,000 people suffer from leukemia annually in JapanCancer Information Service, National Cancer Research Center "Cancer registry and statistics"(Source).(4) Press Release"Fujitsu Fuses Deep Tensor with Knowledge Graph to Explain Reason and Basis Behind AI-Generated Findings" (September 20, 2017)

About Fujitsu

Fujitsu is the leading Japanese information and communication technology (ICT) company, offering a full range of technology products, solutions, and services. Approximately 132,000 Fujitsu people support customers in more than 100 countries. We use our experience and the power of ICT to shape the future of society with our customers. Fujitsu Limited (Code: 6702) reported consolidated revenues of 4.0 trillion yen (US $36 billion) for the fiscal year ended March 31, 2019. For more information, please see http://www.fujitsu.com.

About Fujitsu Laboratories

Founded in 1968 as a wholly owned subsidiary of Fujitsu Limited, Fujitsu Laboratories Ltd. is one of the premier research centers in the world. With a global network of laboratories in Japan, China, the United States and Europe, the organization conducts a wide range of basic and applied research in the areas of Next-generation Services, Computer Servers, Networks, Electronic Devices, and Advanced Materials. For more information, please see http://www.fujitsu.com/jp/group/labs/en/.

Technical ContactsFujitsu Laboratories Ltd.Artificial Intelligence LaboratoryE-mail: qa_fy2019@ml.labs.fujitsu.com

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Fujitsu Improves Efficiency in Cancer Genomic Medicine in Joint AI Research with the Institute of Medical Science at the University of Tokyo -...

REDWOOD CITY, Calif., Nov. 7, 2019 /PRNewswire/ --Genomic Health, Inc.(NASDAQ: GHDX) announced that its stockholders voted to approve the company's proposed combination with Exact Sciences Corp (NASDAQ: EXAS) at a special meeting held earlier today.

As previously announced, on July 29, 2019, Genomic Health and Exact Sciences entered into the merger agreement by which Exact Sciences will acquire Genomic Health in a cash and stock transaction. With the receipt of the required stockholder approval, Genomic Health and Exact Sciences expect to close the transaction on Friday, November 8 subject to satisfaction of the remaining customary closing conditions.

Final vote tallies from the Genomic Health special meeting of stockholders are subject to certification by the Company's inspector of elections and will be included in a report to be filed by the Company with the Securities and Exchange Commission (the "SEC").

AboutGenomic HealthGenomic Health, Inc. (NASDAQ: GHDX) is the world's leading provider of genomic-based diagnostic tests that help optimize cancer care, including addressing the overtreatment of the disease, one of the greatest issues in healthcare today. With its Oncotype IQGenomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DXgene expression tests that have been used to guide treatment decisions for over 1 million cancer patients worldwide.Genomic Healthis expanding its test portfolio to include additional liquid- and tissue-based tests, including the Oncotype DXAR-V7 Nucleus Detecttest. The company is based inRedwood City,California,with international headquarters inGeneva,Switzerland. For more information, please visitwww.GenomicHealth.comand follow the company on Twitter:@GenomicHealth,Facebook,YouTubeandLinkedIn.

This press release contains statements, including statements regarding the merger that are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created thereby. Forward-looking statements, which are based on certain assumptions and describe future plans, expectations and events, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this press release regarding the expected closing of the merger are forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Genomic Health's control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the following: the ability of the parties to satisfy the remaining closing conditions in order to close the proposed merger with Exact Sciences Corporation and other risks as detailed from time to time in Genomic Health's reports filed with the SEC, including its annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other documents filed with the SEC.

There can be no assurance that the merger or any other transaction described will in fact be completed in the manner described or at all. Any forward-looking statement speaks only as of the date on which it is made, and Genomic Health assumes no obligation to update or revise such statement, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

GHDX-F

SOURCE Genomic Health, Inc.

http://www.GenomicHealth.com

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Genomic Health Stockholders Approve Proposed Acquisition by Exact Sciences - PRNewswire