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—for the nation’s two largest public lab companies—there is plenty
Tag: association for molecular pathology
THIS MONTH, AT LEAST THREE CLINICAL LABORATORY DIRECTORS got letters from the Food and Drug Administration raising questions about assays for the Zika virus.
The letters say the tests appear to meet the FDA’s definition of a medical device and thus are subject to premarket clearance, approval, or Emergency Use Authorization. In the letters sent to
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 LDTs became a serious concern when labs developing LDTs were no longer involved
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 since passage of the CLIA 1988 bill.
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 bureaucratic oversight of LDTs. The FDA said that this new layer of regulation will be phased
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 tests that are used by healthcare professionals
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 Medicare officials to
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 invalidated some of the patents held by Myriad for the BRCA 1
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, Germany, which will purchase Aperio Technologies, Inc., of Vista, California.
Founded by Dirk Soenksen in
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.
It was July 29 when the United States Court of Appeals, the