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Hurdles Continue When Labs Request Genetic Test Coverage

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PacBio Beefs Up with Purchase of Omniome for $800 Million

FORWARD-LOOKING PATHOLOGISTS AND LAB ADMINISTRATORS understand that the next big game in medical laboratory testing will be assays built upon genome sequencing. They also know that several companies are racing to produce gene sequencing instruments that are faster, simpler, and less costly in order t…

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Several Big Surprises in 2018’s Top 10 Lab Stories

CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laborator…

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Illumina to Pay $1.2 Billion to Acquire Pacific Biosciences

IT’S AN ACQUISITION THAT BRINGS TOGETHER two different gene sequencing technologies into one firm. On Nov. 1, Illumina, Inc., announced an agreement to acquire Pacific Biosciences (PacBio) for $1.2 billion. This deal will bolster Illumina’s already-dominant posit…

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More Primary Care Docs Will Offer Genetic Tests

CEO SUMMARY: This summer, both Geisinger Health and Sanford Health will introduce genetic tests designed specifically for use by primary care physicians in their daily practice. This is a significant milestone on the road to wider deployment of precision medicine services. In the case of …

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February 29, 2016 Intelligence: Late Breaking Lab News

Sandy, Utah-based Sure Genomics is the latest genetic testing company to get a letter from the Food and Drug Administration asking why the company is marketing its SureDNA genetic testing kit to consumers without first obtaining clearance from the federal agency. Th…

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August 24, 2015 Intelligence: Late Breaking Lab News

California is always in the forefront of states doing innovative things. It announced a public-private effort to develop a clinical laboratory assay that “will enable detection of all known pathogens with a single DNA sequencing test, to diagnose acute infections in hospitalized patients.” Fundin…

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More Genetic Counseling Leads to Fewer Lab Tests

CEO SUMMARY: Cigna was the first national health insurer to require independent board-certified genetic counseling before approving coverage for certain genetic tests. Since launching this program in September 2013, the insurer has seen a 450% increase in genetic counseling for Cigna …

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Whole Genome Sequencing Is Poised for Clinical Use

CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements …

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Cigna Program Addresses Genetic Test Utilization

CEO SUMMARY: Cigna launched a program that requires genetic counseling for patients and pre-authorization of genetic tests. Its partner is InformedDNA, a firm that provides genetic counseling services. The goals include better patient engagement, improved test utilization…

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