TAG:
dna sequencing
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…
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…
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 …
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…
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…
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 …
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 …
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…
Cleveland Clinic Lab Aims to Grow Reference Testing
CEO SUMMARY: In the national market for reference and esoteric testing, Cleveland Clinic Laboratories (CCL) is preparing to expand its presence. It has just moved into a $75 million state-of-the-art laboratory facility and wants to increase its outreach reference testing by four-fold with…
Roche Offers $5.7 Billion To Acquire Illumina Inc.
CEO SUMMARY: Once again, Roche is hunting for gene sequencing and gene analysis technology that can support its goal of being a world leader in gene-based therapeutics and clinical lab testing that utilizes gene tests and molecular diagnostics. Last week, Roche launched a hostile stock te…
CURRENT ISSUE
Volume XXVII No. 9 – June 22, 2020
THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.
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