News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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NIST’s New Standard Genetic Reference Specimen Promises to Increase Accuracy of Clinical Pathology Laboratories Using Next-Generation Sequencing Technology

Sequencing this new DNA standard reference material enables medical laboratories to verify if their DNA test results are accurate

To reduce the variability in genetic test results that has been observed across different clinical laboratories and pathology groups, the National Institute for Standards and Technology (NIST) has introduced a new standard DNA reference. This is another step forward to improve transparency in the quality and accuracy of genetic test results produced by medical laboratories in the United States and abroad.

Even as scientists continue to identify genetic mutations that could cause various cancers and other diseases, such as Alzheimer’s and cystic fibrous, studies have demonstrated that DNA test results from the same specimen can vary depending on which medical laboratory performs the whole-genome sequencing analysis. This is partly due to variances in the technology, chemicals and processes used for the testing. Therefore, ensuring consistently reliable test results has been difficult, which could lead to inaccurate or missed diagnoses.

That is why a new standard DNA reference material developed by the National Institute for Standards and Technology has the potential to help DNA sequencing facilities to verify if their DNA test results are accurate. The new reference material, NIST RM 8398, was designed to improve the accuracy of diagnostic laboratories that analyze DNA using “next-generation sequencing” (NGS) technology. (more…)

For Second Time in Three Years, OPKO Health Will Acquire a Clinical Laboratory Company by Spending $1.47 Billion to Acquire Bio-Reference Laboratories

When completed, this acquisition means that the third largest public lab company in the United States will be owned by a multinational biopharmaceutical and diagnostics firm

It’s a big medical laboratory acquisition that has some experts on Wall Street shaking their heads. Last Thursday, it was announced that OPKO Health Inc. of Miami, Florida, would pay $1.47 billion to acquire Bio-Reference Laboratories Inc. (NASDAQ: BRLI), the nation’s third largest full-service clinical laboratory. OPKO (NYSE: OPK) is a multinational biopharmaceutical and diagnostics company in Miami, Florida.

No cash is involved in this purchase. OPKO will pay for the acquisition by exchanging 2.75 shares of OPKO common stock for each share of BRLI common stock. The deal puts a value of BRLI’s common stock of $52.58 per share, the companies announced.

The boards of directors of both companies have already approved the deal, which should close in the second half of the year.
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New High-Tech Mobile Medical Laboratories Deployed by the U.S. Navy and a European Consortium Use Genetic Analysis to Get Rapid Diagnosis of Ebola

These genetic tests cut time to answer from days to a few hours, reducing the risk of exposing non-infected patients and improving outcomes for Ebola patients

In response to the continuing outbreak of Ebola in the West African countries of Guinea, Liberia, and Sierra Leone, more attention has been given to medical laboratory testing in these countries, along with a rush to develop diagnostic tests that can detect Ebola faster and more accurately without the need for state-of-the art clinical laboratories that are uncommon in those nations.The lack of even limited basic services in the region, such as electricity, hinders any attempt to install modern diagnostic facilities and clinical laboratories essential to controlling and preventing further spread of the disease. Another issue is the lack of trained pathologists, Ph.Ds., and clinical laboratory scientists to staff such labs in those nations.

One solution to this challenge, however, is for developed nations to provide mobile medical laboratories and hospital facilities. Such resources have been contributed by the United States, Canada, and several European countries. (more…)

Google’s Latest Healthcare Initiative is to Put Clinical Laboratory Biomarkers on Nanoparticles to Enable In Vitro Health Monitoring by Consumers

Concept is for patients to take a pill containing nanoparticles programmed to detect cancers or other disease symptoms and a wearable gadget would report their findings

Google is using the same biomarker molecules as clinical laboratories in an attempt to enable in vitro monitoring of an individual’s health status. The device is under development and represents yet one more effort by Google (NASDAQ:GOOG) to penetrate the market for consumer health services.

This futuristic project is under development by the Google X Life Sciences team. The goal is create a device that would allow patients to noninvasively self-diagnose most diseases and health conditions.

The team is led by Andrew Conrad Ph.D.. The device under development is called the NanoParticle platform. It is a tool that continuously monitors an individual’s health status from the inside and reports what it finds through a wearable, watch-like device. (more…)

National Institutes of Health Creates Partnership with Big Pharma to Improve Development Success of New Drugs and Diagnostics and Speed FDA Clearance

Pathology groups and clinical laboratories are among the beneficiaries if the Accelerating Medicines Partnership achieves its goals

Power players in healthcare are about to invest nearly a quarter of a billion dollars to accelerate the time it takes for new medical discoveries to gain regulatory approval and enter clinical use. The emphasis will be on both therapeutic drugs and diagnostics, making this an important development for in vitro diagnostics companies and medical laboratories.

Anchors to this new initiative are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Their partners are 10 pharmaceutical companies and six nonprofit groups. The goal is to jumpstart research to find targets for new drugs and diagnostics, noted a Genomeweb.com article. (more…)

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