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…)

Partnership of Illumina and bioMérieux Proposes an Epidemiology Service to Provide Hospitals and Public Health Officials ‘Out-of-the-Box’ Genomic Pathogen Solutions

This collaborative effort with microbiology labs will keep microbiologists at the forefront of infectious disease diagnostics

A partnership of San Diego-based genome sequencing company Illumina, and the French multinational, in vitro diagnostics company bioMérieux, plans to launch a next-generation sequencing (NGS) epidemiology service that will allow microbiologists to rapidly identify strains that threaten hospital inpatients and public health, according to a press release distributed by the Illumina-bioMérieux team.

Illumina-bioMérieux Service to Aid Hospital and Public Health Labs 

Illumina designated sequencing laboratories with Illumina MiSeq® systems will collaborate with microbiologists working in hospital and public health laboratories to prevent, rapidly track, and contain infectious disease agents in hospitals and communities. (more…)

Digital PCR Poised to Give Traditional Real-Time PCR a Run for Its Money in Gene Sequencing and Development of New Medical Laboratory Tests

Adoption of digital PCR is slow at this time, but pathologists may want to track how researchers use this technology in the new clinical laboratory assays they use

Molecular pathologists will be interested to learn that there is a new contender in the polymerase chain reaction (PCR) arena. It is digital PCR, and it has specific advantages over traditional real-time PCR methods.

For example, digital PCR can target specific DNA sequences in just one molecule of DNA. This new tool allows researchers to isolate rare genetic mutations too difficult to segregate with real-time PCR, noted a report from Insight Pharma Reports. (more…)

Pathologists at South Carolina Hospital Are Preparing to Use Next Generation Gene Sequencing for Cancer Patients

Strategic collaboration promises leap forward in personalized medicine that could be game-changing for medical laboratories

One early effort to apply next generation gene sequencing to cancer diagnostics and therapeutics is a collaboration that involves Greenville Hospital System University Medical Center (GHS) in Greenville, South Carolina, and Lab21, Inc., a British company. GHS wants to use next gene sequencing as an integral part of the evaluation of every cancer patient cared for in the GHS system.

The partnership between GHS and Lab21 provides evidence for pathologists and clinical laboratories that first mover hospitals and health systems are now taking steps to incorporate next generation gene sequencing (NGS) into their cancer care protocols. Forward-looking pathology groups are already taking steps to expand their capabilities to perform and interpret genetic tests. (more…)

Experts Predict Explosive Growth in Molecular Diagnostics and Next-Generation Gene Sequencing for Clinical Pathology Laboratories

Upcoming Executive War College conference features experts on molecular and genetic testing

Explosive rates of growth in clinical use of molecular diagnostics assays seen in recent years are about to be matched by a new opportunity for medical laboratory testing. Experts predict the coming “big thing” in clinical laboratory and anatomic pathology will be next-generation gene sequencing (NGS).

This should be welcome news for financially-beleaguered pathology groups and clinical lab organizations. Lab tests that incorporate next-generation gene sequencing technologies are expected to offer clinicians greater value by making it possible to more accurately detect and characterize disease at earlier stages. For this reason, these lab tests are expected to be adequately reimbursed by most government and private payers.

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