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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Sequenom Enters Into Collaboration With UC San Diego to Fine Tune Liquid Biopsy Cancer Test
By Ron Shinkman, Editor, Laboratory Industry Report Sequenom, the San Diego-based genetic laboratory, has entered into a research collaboration with the Moores Cancer Center at the University of California at San Diego to determine the utility of the company's...
FTC Issues Guidance on Unfair Competition Enforcement
By Kelly A. Briganti, Editorial Director, G2 Intelligence While experts have not proclaimed it an overwhelmingly helpful resource, the Federal Trade Commission (FTC) released a Statement of Enforcement Principles Regarding "Unfair Methods of Competition" Under...
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)...