Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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”
Air Force Expands Longitudinal Genomics Study
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The Air Force Medical Service (AFMS) in partnership with the Coriell Institute for Medical Research (Camden, N.J.) have launched phase II of the longitudinal Clinical Utility Study (CUS). CUS...
Millenium Health Gets Win on Appeal of POCT Cup Litigation; But What’s Next?
By Kelly A. Briganti, Editorial Director, G2 Intelligence It's been several years but Millenium won an appeal in a lawsuit Ameritox brought against the company arguing Millenium's point-of-care testing (POCT) cup program violated unfair competition laws and the...
LabCorp Releases Hereditary Cancer Test Panel
By Ron Shinkman, Editor, Laboratory Industry Report LabCorp has launched a prognostic panel intended to gauge the risk of patients being stricken by the most common forms of cancer. The panel, known as VistaSeq, will be used to identify patients at a higher risk of...
NIH Expands eMerge Initiative With $48M in Phase III Awards
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The National Institutes of Health announced awards for $48 million in the third round of funding for the eMERGE program. The Electronic Medical Records and Genomics (eMERGE) project's primary goal...