association for molecular pathology Archives

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association for molecular pathology

FDA Expected to Publish Proposed LDT Rule in August

By Scott Wallask | From the Volume XXX, No. 10 – July 10, 2023 Issue

CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…

Post-COVID: Repurposing Excess PCR Instruments

By Robert Michel | From the Volume XXVIII, No. 15 – November 8, 2021 Issue

CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…

2014’s PAMA Fix Comes Back to Haunt Big Labs

By R. Lewis Dark | From the Volume XXIV No. 11 – August 7, 2017 Issue

AS YOU READ THE INTELLIGENCE BRIEFINGS IN THIS ISSUE about lab industry efforts to convince Congress, the administration, and the new leaders of the Centers for Medicare and Medicaid Services to delay implementation of the PAMA final rule on market price reporting, keep in mind that�…

FDA Steps Up Test Enforcement, Saying Tests Need Clearance

By Joseph Burns | From the Volume XXIII No. 4 – March 21, 2016 Issue

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FDA Official Makes Case In Favor of LDT Guidance

By Joseph Burns | From the Volume XXII, Number 18 – December 28, 2015 Issue

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…

Public Comment Started on FDA LDT Regulations

By Joseph Burns | From the Volume XXI No. 15 – November 3, 2014 Issue

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

By Joseph Burns | From the Volume XXI No. 11 – August 11, 2014 Issue

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

By Joseph Burns | From the Volume XXI No. 5 – April 7, 2014 Issue

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”

By Robert Michel | From the Volume XX No. 8 – June 17, 2013 Issue

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…

Volume XXXI, No. 5 – April 8, 2024

The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.

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