TAG:
association for molecular pathology
FDA Steps Up Test Enforcement, Saying Tests Need Clearance
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FDA Official Makes Case In Favor of LDT Guidance
CEO SUMMARY: Forty years ago, pathologists in hospital and academic labs worked closely with treating physicians to produce laboratory-developed tests for discrete clinical cases. Seeing that, the FDA decided not to regulate those tests, an FDA official said. Over time, however, use of L…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
FDA Notifies Congress that It Will Regulate LDTs
CEO SUMMARY: Since 2006, the FDA has said it has the authority to regulate lab-developed tests, but it has held off on doing so. Now the agency says it’s time, defining LDTs as being, “designed, manufactured, and used within a single laboratory. LDTs include some genetic tests and tes…
Congress’ New SGR Law Has Mixed News for Labs
CEO SUMMARY: Once again, the lab industry faces a mixed bag following passage of a new law by Congress last week. Besides the one-year fix for the SGR, H.R. 4302 also has language that may defer adjustments to Medicare Part B lab test fees until 2017 and creates a new procedure for Medica…
June 17, 2013 “Intelligence: Late Breaking Lab News”
Big news last week was the unanimous decision by the Supreme Court that natural genes cannot be patented. The case was brought against Myriad Genetics, Inc., by the American Civil Liberties Union, the Association for Molecular Pathology, and several other plaintiffs. The decision…
Leica, Aperio, Myriad, AMP, Hologic, Gen-Probe
LEICA BIOSYSTEMS TO ACQUIRE APERIO FOR THE SECOND TIME IN AS MANY YEARS, a global leader in histology systems and products has announced that it will acquire one of the leading digital pathology companies. This time it is Leica Biosystems of Nussloch, German…
Myriad Wins Federal Appeal In Important Gene Patent Suit
IN THE CLOSELY-WATCHED COURT CHALLENGE involving gene patents, Myriad Genetics, Inc., of Salt Lake City, Utah, recently won a favorable decision from the federal appeals court. However, legal experts believe that the plaintiffs are likely to ask the Supreme Court to review the case. …
Joint Venture Launches Molecular Pathology Lab
CEO SUMMARY: As genomic medicine advances, researchers into various diseases quickly recognize the need to incorporate molecular pathologists onto their teams. In Grand Rapids, Michigan, a large integrated health system and a private research institute have come together to jointly fund a…
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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