Daily Archives: May 17, 2020

INDIANAPOLIS (AP) A dime-size nanochip developed by a world-renowned researcher who recently relocated to Indianapolis could help transform the practice of medicine. It could also turn Indianapolis into a manufacturing and research hub for radically new disease and trauma treatment techniques.

It all began in August 2018, when Chandan Sen, one of the worlds leading experts in the nascent field of regenerative medicine, moved his lab from Ohio State University to the Indiana University School of Medicine. He brought along a team of about 30 researchers and $10 million in research grants, and now serves, among a myriad of other positions, as director of the newly formed Indiana Center for Regenerative Medicine and Engineering, to which IU pledged $20 million over its first five years.

IU recruited Sen away from Ohio State in part because of its desire not just to promote academic research in his field but also to help develop practical, commercial products and uses for his breakthroughs.

A scientist prefers to be in the lab and keep on making more discoveries, said Sen, 53.

But I thought that, unless we participate in the workforce development process and the commercialization process, I dont think that the businesspeople would be ready to do it all by themselves. Because its such a nascent field.

Its definitely new and its potential sounds like the stuff of science fiction.

Regenerative medicine, as its name hints, seeks to develop methods for replacing or reinvigorating damaged human organs, cells and tissues.

For instance, instead of giving a diabetic a lifetimes worth of insulin injections, some of his skin cells could be altered to produce insulin, curing him. Such techniques might also be used for everything from creating lab-grown replacement organs to, someday, regenerating severed limbs.

Regenerative medicine offers a form of medicine that is neither a pill nor a device, Sen said.

It is a completely new platform, where you dont necessarily depend on any given drug, but are instead modifying bodily functions.

Sen and his teams signal contribution to the field is a technique theyve dubbed tissue nanotransfection, or TNT. Put simply, it uses a nanotechnology-based chip infused with a special biological cargo that, when applied to the skin and given a brief electrical charge, can convert run-of-the-mill skin cells into other cell types. Potentially, the technique could be used for everything from regrowing blood vessels in burn-damaged tissue to creating insulin-secreting cells that could cure diabetics.

Obviously, such applications are still down the road a ways. But the technology is far enough along that some products are already making it to market and investors, entrepreneurs and established companies are sniffing around for opportunities. According to the Alliance for Regenerative Medicine, more than 1,000 clinical trials worldwide are using regenerative medicine technologies.

Thousands of patients are already benefiting from early commercial products, and we expect that number will grow exponentially over the next few years, said Janet Lambert, the alliances CEO.

Lambert predicts that the number of approved gene therapies will double in the next one to two years. Last year, the U.S. Food and Drug Administration predicted it would be approving 10 to 20 cell and gene therapies each year by 2025.

These new techniques could do more than just revolutionize medicine. They could also upend the medical industry as we know it. And the IU School of Medicine and Indianapolis could lead the way.

There are really only two or three places in the country that did the kind of comprehensive work that Dr. Sens group was doing, said Anantha Shekhar, executive associate dean for research at IU School of Medicine. And they were doing it from the lab all the way to the clinic, where they were already applying those technologies in patients.

So it was very attractive to think of starting with a bang bringing a comprehensive group here and creating a new center.

Instead of merely treating chronic conditions, regenerative medicine could end them, once and for all.

For instance, consider a car with an oil leak. The traditional medical approach might be to live with the chronic condition by pouring in a fresh quart of oil every few days. The regenerative medicine approach would fix the leak. Its good for the car, good for the cars owner but not necessarily good for the guy who was selling all those quarts of oil.

Which is why these new techniques, if they catch on, could cause turmoil in the medical industry.

Because regenerative medicine has the potential to durably treat the underlying cause of disease, rather than merely ameliorating the symptoms, this technology has the potential of being extremely disruptive to the current practice of medicine, Lambert said.

This has the potential to be hugely disruptive, Sen added, because so much of medicine today relies on huge industrial infrastructures to manage, not cure, chronic diseases and disabilities.

If such disruption comes to pass, the leaders of 16 Tech, a 50-acre innovation district northwest of downtown that aspires to house dozens of medical-related startups and established firms, would love to be its epicenter.

The Center for Regenerative Medicine will be one of the tenants of 16 Techs first building, a $30 million, 120,000-square-foot research and office building scheduled to open in June.

Regenerative medicine is probably one of the next major waves of medical innovation in the world, 16 Tech CEO Bob Coy said. To have him here doing this work gives Indianapolis and Indiana an opportunity to develop an industrial cluster in regenerative medicine.

Coy believes the most momentous early step on that road was the recent establishment by Sen of masters and doctoral programs in regenerative medicine at the IU School of Medicine. Its the first degree of its type in the country, earning IU and Indianapolis the enviable status of first mover.

I think, for example, of (Pittsburghs) Carnegie Mellon University, which, back in the late 1960s, created the first college of computer science in the country, Coy said. And now you know Carnegie Mellons reputation in computer science.

What isnt in place yet is a state or city program to promote development of a regenerative medicine hub.

We need to start doing that, Coy said. That means putting a lot of the infrastructure in place to support startups that are based on this technology, as well as recruiting companies that want to collaborate with Dr. Sen.

In spite of the lack of a coherent recruitment program, Coys phone has started to ring, thanks largely to Sens presence.

There have been a few meetings Ive had with people who already have relationships with him, who, when they come to town, have reached out to meet and talk about what were doing at 16 Tech, he said.

One of the first 16 Tech startups with designs on the regenerative medicine niche is Sexton Biotechnologies.

The company was groomed by Cook Regentec, a division of Bloomington-based Cook Group charged with incubating and accelerating technologies for regenerative medicine and the related field of cell gene therapy.

Any products that show promise are either folded into the company, turned into their own divisions or, as in Sextons case, spun off as an independent entity with Cook retaining a financial stake.

Its a measure of the newness of this field that Sextons 17 employees arent working on new medicines, but rather marketing basic tools needed to conduct research. The companys offerings include a vial for storing cell and gene products in liquid nitrogen, and a cell culture growth medium.

Theres a ready market for such tailor-made gear, because, for years, researchers in the regenerative medicine field had to make do with jury-rigged equipment.

What most of those companies did was repurpose things like tools from the blood banking industry, or tools from bio pharma, said Sean Werner, Sextons president.

So thats why a lot of newer companies are starting to build tools explicitly for the industry, as opposed to everybody just having to cobble together stuff that was already out there.

Werner said investors recognize the momentous opportunity in regenerative medicine and are flocking to the field.

Its not something you have to explain, he said. Companies and VC groups are trying to get a piece of it.

What has investors and medical researchers charged up is the almost unlimited range of potential applications, from healing burns to, perhaps someday, regenerating limbs.

I think it would be a huge revolution if were able to, for example, regenerate insulin-secreting cells in children who have become juvenile diabetics or have for whatever reason lost their pancreas, Shekhar said. Those are the kinds of things that will start to change the way we see certain diseases.

Lambert predicted that, as the science advances, so will the business case.

While early programs focused primarily on rare genetic diseases and blood cancers, were already seeing the field expand into more common age-related neurological disorders, such as Parkinsons and Alzheimers, she said.

I expect this trend to continue in the coming years, greatly increasing the number of patients poised to benefit from these therapies.

Werner said regenerative medicine also is seeking advancements in manufacturing technologies that will lower the cost of product development.

It all adds up to a huge opportunity the state is well-positioned to seize, Werner believes.

Indiana is a perfect place for this kind of thing to really ramp up, he said. Theres no reason we cant lead the field.

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Source: Indianapolis Business Journal

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IU team pursues breathtaking regenerative medicine advances - The Advocate

BIRMINGHAM, Ala. - Is personalized medicine cost-effective? University of Alabama at Birmingham researcher Nita Limdi, Pharm.D., Ph.D., and colleagues across the United States have answered that question for one medical treatment.

Patients experiencing a heart attack -- known as a myocardial infarction or an acute coronary syndrome -- have sharply diminished blood flow in coronary arteries, with a high risk of heart failure or death. Coronary angioplasty, a procedure to open narrowed or blocked arteries in the heart, and percutaneous coronary intervention, known as PCI or stenting, can restore blood flow to minimize damage to the heart. These procedures reduce the risk of subsequent major adverse cardiovascular events, or MACE, which include heart attacks, strokes or death.

But then, a treatment decision has to be made.

After stenting, all patients are treated with two antiplatelet agents for up to one year. Which combination of antiplatelets is best? The answer comes through pharmacogenomics, says Limdi, a professor in the UAB Department of Neurology and associate director of UAB's Hugh Kaul Precision Medicine Institute.

Pharmacogenomics combines pharmacology, the study of drug action, with genetics, the study of gene function, to choose the best medication according to each patient's personal genetic makeup. This is also called precision medicine -- tailored medical treatment for each individual patient.

The most commonly used antiplatelet combination after PCI is aspirin and clopidogrel, which is trademarked as Plavix. Clopidogrel is converted to its active form by an enzyme called CYP2C19. However, patients respond to clopidogrel differently based on their genetic makeup.

More than 30 percent of people have loss-of-function variants in the CYP2C19 gene that decrease the effectiveness of clopidogrel. The FDA warns that these patients may not get the full benefit of clopidogrel, which would increase the risk of MACE. So the FDA advises doctors to consider a different treatment such as prasugrel or ticagrelor, trademarked as Effient and Brillinta, to replace clopidogrel.

While most patients undergoing PCI receive clopidogrel without receiving any CYP2C19 loss-of-function testing, academic institutions like UAB that offer precision medicine use pharmacogenomics to guide the selection of medication dosing.

In 2018, Limdi and other investigators across nine United States universities -- all members of the Implementing Genomics in Practice consortium, or IGNITE -- showed that patients with loss-of-function variants who were treated with clopidogrel had elevated risks. There was a twofold increase in MACE risk for PCI patients, and a threefold increase in MACE risk among patients with acute coronary syndrome who received PCI, as compared to patients prescribed with prasugrel or ticagrelor instead of clopidogrel. Prasugrel and ticagrelor are not influenced by the loss-of-function variant and can substitute for clopidogrel, but they are much more costly and bring a higher risk of bleeding.

The IGNITE group then leveraged this real-world data to conduct an economic analysis to determine the best drug treatment for these heart disease patients.

A study led by Limdi and colleagues, published in the Pharmacogenomics Journal, examines the cost-effectiveness of genotype-guided antiplatelet therapy for acute coronary syndrome patients with PCI. This cost-effectiveness study is the first to use real-world clinical data; many cost-effectiveness studies use clinical trial data, which tends to exclude the sicker patients normally seen in clinical practice.

The study compared three main strategies: 1) treating all patients with clopidogrel, 2) treating all patients with ticagrelor, or 3) genotyping all patients and using ticagrelor in those with loss-of-function variants.

"We showed that tailoring antiplatelet selection based on genotype is a cost-effective strategy," Limdi said. "Support is now growing to change the clinical guidelines, which currently do not recommend genotyping in all cases. Evidence like this is needed to advance the field of precision medicine."

Costs, QALYs and ICERs

In the analysis, Limdi and colleagues considered differences in event rates for heart attacks and stent thrombosis in patients receiving clopidogrel versus ticagrelor versus genotype-guided therapy, during the one-year period following stenting. They also included medical costs from those events that are borne by the payer, such as admissions, procedures, medications, clinical visits and genetic testing. The analysis considered variations in event rates and medication costs over time to ensure that the results held under different scenarios.

The study uses an economic measure -- the QALY, which stands for the quality-adjusted life year.

"First, we looked at which strategy provided the highest QALY," Limdi said. "The QALY is the gold standard for measuring benefit of an intervention -- in our case, genotype-guided treatment compared to treatment without genotyping. Universal ticagrelor and genotype-guided antiplatelet therapy had higher QALYs than universal clopidogrel -- so those are the best for the patient."

But health care resources are not infinite. So, Limdi and colleagues then evaluated whether those interventions that have higher QALYs were also reasonable from a cost perspective. This analysis considered the willingness to pay. What would a payor or a patient pay for the highest QALY?

"In our case, the payor would recognize that ticagrelor is more expensive than clopidogrel -- $360 per month vs. $10 per month -- and there is a $100 cost for each genetic test," Limdi said. "So, from the payor perspective, the more effective strategy (one with a higher QALY) -- if more expensive (higher cost) -- would have to lower the risks of bad outcomes like heart attacks and strokes for the gains in QALY that are at, or below, the willingness-to-pay threshold."

A calculation called incremental cost-effectiveness ratios, or ICERs, assesses the incremental cost of the benefit (improvement in QALY). In the United States, a treatment is considered cost-effective if its associated ICER is at or below the willingness-to-pay threshold of $100,000 per QALY.

"In our assessment, the two strategies with the highest QALY had very different ICERs," Limdi said. "The genotype-guided strategy was cost-effective at $42,365 per QALY. Universal ticagrelor was not; it had an ICER of $227,044 per QALY."

The researchers also looked at some secondary strategies for a real-world reason. A number of clinicians now prescribe ticagrelor or prasugrel for the first 30 days after PCI, which is considered a period of greater risk, and then switch their patients to the less expensive drug clopidogrel.

The secondary analysis allowed Limdi and colleagues to explore the cost-effectiveness of giving all patients ticagrelor for 30 days, and then switching them to clopidogrel, without genetic testing, versus switching the patients based on genotype. Both strategies were better -- in terms of QALYs -- than a universal switch to clopidogrel at 30 days. However, neither of the two appeared to be cost-effective. Because these secondary strategies used estimated parameters, "the findings should only be considered as hypothesis-generating," Limdi said.

Read more:
Precision medicine guides choice of better drug therapy in severe heart disease - Science Codex

Sarepta Therapeutics (NASDAQ:SRPT)'s stock had its "buy" rating reaffirmed by investment analysts at Robert W. Baird in a report released on Friday, TipRanks reports. They currently have a $192.00 target price on the biotechnology company's stock. Robert W. Baird's target price suggests a potential upside of 35.93% from the company's previous close.

Other analysts also recently issued research reports about the stock. BidaskClub raised shares of Sarepta Therapeutics from a "hold" rating to a "buy" rating in a research report on Thursday, May 7th. Nomura Securities reaffirmed a "buy" rating and set a $230.00 price target on shares of Sarepta Therapeutics in a report on Tuesday, February 25th. Cantor Fitzgerald reiterated an "overweight" rating and issued a $217.00 price objective (up previously from $211.00) on shares of Sarepta Therapeutics in a report on Thursday, February 27th. Oppenheimer reissued a "hold" rating on shares of Sarepta Therapeutics in a research report on Thursday, May 7th. Finally, SVB Leerink reaffirmed a "buy" rating and set a $216.00 target price on shares of Sarepta Therapeutics in a research report on Thursday, January 23rd. One investment analyst has rated the stock with a sell rating, one has given a hold rating and twenty-four have given a buy rating to the stock. The company has an average rating of "Buy" and a consensus target price of $193.05.

Shares of NASDAQ SRPT opened at $141.25 on Friday. The stock has a fifty day moving average price of $112.04 and a 200 day moving average price of $112.85. The company has a market cap of $9.91 billion, a P/E ratio of -16.00 and a beta of 1.87. Sarepta Therapeutics has a 12-month low of $72.05 and a 12-month high of $158.80. The company has a current ratio of 8.31, a quick ratio of 7.75 and a debt-to-equity ratio of 0.66.

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Sarepta Therapeutics (NASDAQ:SRPT) last issued its earnings results on Wednesday, May 6th. The biotechnology company reported ($0.23) earnings per share for the quarter, topping the Thomson Reuters' consensus estimate of ($2.17) by $1.94. The company had revenue of $113.67 million during the quarter, compared to the consensus estimate of $118.18 million. Sarepta Therapeutics had a negative return on equity of 64.67% and a negative net margin of 160.96%. The company's revenue was up 30.6% compared to the same quarter last year. During the same quarter in the prior year, the business earned ($1.07) earnings per share. On average, sell-side analysts forecast that Sarepta Therapeutics will post -8.44 EPS for the current fiscal year.

In other news, Director Richard Barry sold 30,000 shares of the company's stock in a transaction that occurred on Friday, May 15th. The stock was sold at an average price of $141.26, for a total transaction of $4,237,800.00. Following the completion of the transaction, the director now directly owns 3,163,813 shares of the company's stock, valued at $446,920,224.38. The transaction was disclosed in a filing with the Securities & Exchange Commission, which can be accessed through the SEC website. Also, Director Hans Lennart Rudolf Wigzell sold 5,000 shares of the stock in a transaction that occurred on Wednesday, March 4th. The stock was sold at an average price of $116.89, for a total value of $584,450.00. Following the sale, the director now owns 18,792 shares in the company, valued at $2,196,596.88. The disclosure for this sale can be found here. 6.60% of the stock is currently owned by corporate insiders.

A number of institutional investors and hedge funds have recently modified their holdings of SRPT. Amundi Pioneer Asset Management Inc. increased its position in Sarepta Therapeutics by 32.8% in the first quarter. Amundi Pioneer Asset Management Inc. now owns 154,611 shares of the biotechnology company's stock worth $18,428,000 after buying an additional 38,194 shares during the period. DNB Asset Management AS acquired a new position in shares of Sarepta Therapeutics during the fourth quarter valued at $1,386,000. Zeke Capital Advisors LLC grew its position in shares of Sarepta Therapeutics by 10.1% during the fourth quarter. Zeke Capital Advisors LLC now owns 5,343 shares of the biotechnology company's stock worth $689,000 after acquiring an additional 491 shares during the last quarter. Assenagon Asset Management S.A. acquired a new stake in shares of Sarepta Therapeutics in the 4th quarter worth about $860,000. Finally, Janney Montgomery Scott LLC lifted its position in Sarepta Therapeutics by 7.7% in the 4th quarter. Janney Montgomery Scott LLC now owns 5,312 shares of the biotechnology company's stock valued at $685,000 after purchasing an additional 382 shares during the last quarter. Hedge funds and other institutional investors own 93.76% of the company's stock.

Sarepta Therapeutics Company Profile

Sarepta Therapeutics, Inc focuses on the discovery and development of RNA-based therapeutics, gene therapy, and other genetic medicine approaches for the treatment of rare diseases. The company offers EXONDYS 51, a disease-modifying therapy for duchenne muscular dystrophy (DMD). Its products pipeline include Golodirsen, a product candidate that binds to exon 53 of dystrophin pre-mRNA, which results in exclusion or skipping of exon during mRNA processing in patients with genetic mutations; and Casimersen, a product candidate that uses phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 45 of the DMD gene.

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But that doesnt mean you have to limit yourself to defensive stocks. You can find some quality buy-and-hold stocks that offer some attractive growth prospects.

View the "10 Buy and Hold Stocks to Add to Your Portfolio".

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Sarepta Therapeutics' (SRPT) "Buy" Rating Reiterated at Robert W. Baird - MarketBeat

There has been a rise in government funding and research programs which is paving the way for the growth of the gene editing technologies in diagnostic platforms market. For example, the National Institutes of Health (NIH) has allocated funding on the study of clustered regularly interspaced short palindromic repeats (CRISPR) from 2011 to 2018. The NIH spent about US$ 3,083.4 million between the fiscal year 2011 and 2018 on a total of 6,685 projects. The funding has been increased by 213.1% between the fiscal year 2014 and 2015.

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Moreover, with the help of NIH Common Funds support, National Institutes of Health (NIH) launched Somatic Cell Genome Editing (SCGE) program on January 2018 which is working to improve the effectiveness and specificity of gene editing techniques to assist in the diminishing of the burden of common and erratic diseases caused by genetic variations. The program aims at developing quality tools to execute and determine effective and harmless genome editing in somatic cells of the body. These tools will be made extensively available to the research community to lessen the time and expense which is required to develop new therapies. Furthermore, Somatic Cell Genome Editing program will award approximately US$ 190 million to biomedical researchers over the six years starting from 2018 till 2023. Hence, these types of research programs and funding given to the researchers will help the diagnostic platforms to get the tools which will aid them in carrying out gene editing and will drive the future market of the gene editing technologies in diagnostic platforms.

The number of CRISPR related publications, as listed in the SCOPUS database of peer-reviewed research, shows the surge in funding. Between 2015 and 2016, the number of such publications raised 117.5% which is 1,457. In 2019, the number surpassed 3,900 and increased at a rate of 4.8%. Overall, 12,900 papers associated with the technique have been published since 2011, Thus, this increasing research is expected to assist in the gene editing technologies in diagnostic platforms market growth over the forecast period.

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The detailed research study provides qualitative and quantitative analysis of gene editing technologies in diagnostic platforms market. The market has been analyzed from demand as well as supply side. The demand side analysis covers market revenue across regions and further across all the major countries. The supply side analysis covers the major market players and their regional and global presence and strategies. The geographical analysis done emphasizes on each of the major countries across North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

Key Findings of the Report:

In terms of revenue, the gene editing technologies in diagnostic platforms market is expected to reach US$ 7,004.8 Mn by 2027, expanding at 14.4% CAGR during the forecast period due to the rising government funding for genome editing and engineering

Beam Therapeutics, Bio-Connect Group, CRISPR Therapeutics, Editas Medicine, GeneCopoeia, Inc., GenScript, Horizon Discovery Ltd., Inscripta, Inc., Integrated DNA Technologies, Inc., Intellia Therapeutics, Inc., Lonza Group Ltd., Merck KGaA, New England Biolabs, OriGene Technologies, Inc., Pairwise, Precision Biosciences, Sangamo Therapeutics, STEMCELL Technologies Inc., Thermo Fisher Scientific Inc., Transposagen Biopharmaceuticals, Inc. are the key market participants operating in the gene editing technologies in diagnostic platforms market.

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Gene Editing Technologies in Diagnostic Platforms Market:

By Technology

CRISPR

TALEN

ZFN

Others

By Application

Cell Line Engineering

Genetic Engineering

Animal Genetic Engineering

Plant Genetic Engineering

Others

By End-User

Biotechnology & Pharmaceutical Companies

Academic and Research Institutions

Contract Research Organization (CROs)

By Geography

North America

U.S.

Canada

Mexico

Rest of North America

Europe

France

The UK

Spain

Germany

Italy

Nordic Countries

Denmark

Finland

Iceland

Sweden

Norway

Benelux Union

Belgium

The Netherlands

Luxembourg

Rest of Europe

Asia Pacific

China

Japan

India

New Zealand

Australia

South Korea

Southeast Asia

Indonesia

Thailand

Malaysia

Singapore

Rest of Southeast Asia

Rest of Asia Pacific

Middle East and Africa

Saudi Arabia

UAE

Egypt

Kuwait

South Africa

Rest of Middle East & Africa

Latin America

Brazil

Argentina

Rest of Latin America

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Gene Editing Technologies in Diagnostic Platforms Market is expected to grow at a CAGR of 14.4% during the forecast period due to the rise in research...