Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
CDC Investing $110 Million in Disease Surveillance and Detection
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Illumina-Backed Helix to Expand Consumer Genetics
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Helix (San Francisco) believes it can vastly expand the nascent consumer genomics market. The company, which announced backing from sequencing giant Illumina (San Diego), will launch a pay-as-you...
Participants in Bundled Payment Pilot Take on Risk
By Kelly A. Briganti, Editorial Director, G2 Intelligence In a pilot project, more than 2,100 providers are increasing their skin in the game of value-based health care reimbursement by taking on financial risk. The Centers for Medicare & Medicaid Services (CMS)...
Roche Boosts Molecular Portfolio with Deals to Acquire GeneWEAVE, Kapa Biosystems
By Stephanie Murg, Managing Director, G2 Intelligence With some 60% of its therapeutic candidates now being co-developed with companion diagnostics, Roche (Basel, Switzerland) is investing in both its diagnostics business and its drug pipeline with two recently...
OPKO, Bio-Reference Complete Deal
By Ron Shinkman, Editor, Laboratory Industry Report Miami-based OPKO Health has completed its acquisition of New Jersey-based Bio-Reference Laboratories. Under the terms of the all-stock deal, Bio-Reference shareholders received 2.75 shares of OPKO stock in a deal...
Rise in Lyme Cases Drives Interest in New Tests
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HCV Testing Strategies Falling Short in Reach
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Court Decides “Absurd” Is Worse than “Potentially Unworkable” When Interpreting 60-Day Repayment Rule
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Changes in Cervical Cancer Screening Impact Chlamydia Testing
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Biocept, UC Irvine to Collaborate on Liquid Biopsies
By Ron Shinkman, Editor, Laboratory Industry Report San Diego-based Biocept will collaborate with the University of California at Irvine to study differences in biomarkers in blood-based specimens versus invasive tissue samples. The intent, officials say, is to be...