TAG:
genetic tests
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…
Payers Using Two Approaches To Price Molecular and Genetic Tests
EXECUTIVE SUMMARY: This analysis, unique to THE DARK REPORT, contrasts the decision of Palmetto GBA to distinguish between “hotspot” tumor panels (meaning those targeting 5 to 50 genes and 51 or more genes) versus “sequencing” tumor panels in coding and pricing NGS test panels, wi…
Newsmaker Interview: Matthew Hawkins
CEO SUMMARY: By now, most pathologists and clinical laboratory administrators recognize that effective use of information technology will be a critical success factor as healthcare systems transform to do population health management and to use “big data” with value-based payment mode…
New Company Tracks Details and Prices For 60,000 Molecular and Genetic Tests
CEO SUMMARY: Advances in the speed, accuracy, and cost of next-generation gene sequencing making it possible for clinical labs to create thousands of new tests. How many new tests? NextGxDx, an information technology company, says the nation’s clinical laboratories are introducing new m…
2015’s Top 10 Lab Stories Show Significant Changes
CEO SUMMARY: During 2015, two stories captured the full attention of most pathologists and clinical lab managers. One was how CMS intends to gather lab price market data as mandated by PAMA. The other was the continued efforts by the FDA to move ahead on proposed guidance for regulation o…
December 7, 2015 Intelligence: Late Breaking Lab News
Last week, a joint laboratory accreditation agreement was announced by AABB and the American Association for Laboratory Accreditation (A2LA). The two associations will now collaborate to allow labs to obtain three assessments under one effort, including AABB accredit…
State of Clinical Lab Industry Likely to Be Mixed in 2016
CEO SUMMARY: Over the next 24 months, it will be essential for every clinical laboratory and anatomic pathology group to develop clinical and financial strategies that meet the changing needs of health insurers, hospitals and health systems, physicians, and patients. THE DARK REPORT provi…
Some Labs Report Faster Pay For Molecular, Genetic Tests
DURING RECENT MONTHS, some labs are reporting improvement in how their claims for certain molecular and genetic tests are being reimbursed. This is progress from the financial crises experienced during 2013 for many labs performing molecular and genetic tests. Disruption in these payments wa…
Toxicology Lab Millennium Pays $256M to DOJ, Files For Bankruptcy
IN ANOTHER MAJOR LAB FRAUD CASE, toxicology lab company Millennium Health will pay $256 million to settle allegations in a whistleblower lawsuit that it overbilled federal healthcare programs for unnecessary lab testing. Just 22 days after this agreement, Millennium Health filed a pe…
New Company Targets Lab Benefit Management
CEO SUMMARY: Soon, the nation’s newest laboratory benefit management company will begin working for Blue Cross Blue Shield of South Carolina. Avalon Healthcare Solutions committed to BCBSSC that it can save money off what the health plan has been spending on clinical lab testing. It wil…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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