News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Study Finds FDA Relied on Flawed Data When Approving High-Risk Medical Devices for Obstetrics and Gynecology; Are There Implications for Regulation of LDTs?

Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market

Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance.

One example involves researchers at the Northwestern University Feinberg School of Medicine. They recently determined that the U.S. Food and Drug Administration (FDA) based approvals of certain medical devices on flawed data.

Announced in a May 2016 statement,  the study, which was published in the journal Obstetrics and Gynecology, will be of special interest to clinical laboratory executives and pathologists who understand that the findings of this study might be useful ammunition in the medical lab industry’s efforts to forestall FDA regulation of laboratory developed tests (LDTs).

Essentially, if these researchers can find obvious flaws in how the FDA reviews a relatively limited number of medical devices, as identified by this study, then how would the FDA cope with the need to review thousands of LDTs in a timely, cost-effective, and rigorous manner? (more…)

FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups

It was national news when the FDA sent notice to Congress on July 31 that it planned to issue draft guidance on regulation of LDTs

After sitting in a state of suspended animation for several years, the Food & Drug Administration’s (FDA) plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of LDTs.

If the federal agency wanted to get the full attention of the clinical laboratory industry, it certainly succeeded. In the four weeks since the FDA alerted Congress of its plans for LDT regulation, there has been a flood of national news stories about this development. (more…)

Clinical Pathology Laboratories File Petition Against Threat of Regulation of Laboratory-Developed Tests

FDA intends to pursue regulation of laboratory-developed tests (LDTs) as medical devices, according to FDA Commissioner Hamburg

FDA regulation of laboratory-developed tests (LDTs) is getting attention again. In recent weeks, FDA Commissioner Margaret Hamburg, M.D. put the clinical laboratory industry on notice that the commission intends to pursue regulation of LDTs.

Pathologists and clinical laboratory scientists have long used LDTs to solve clinical diagnostic problems and as a way to use new technologies to address unmet clinical challenges. As a result, these medical laboratory tests are critically important to the growth of personalized medicine. (more…)

Palmetto GBA Execs Explain MolDx, Its New “Molecular Diagnostic Services” Program for Clinical Pathology Laboratories

Registry for genetic tests and molecular diagnostic assays is one step in process to assess the science and clinical utility

Clinical laboratory and pathologists have dozens of questions about the proposed draft local coverage determinations (LCDs) that Medicare carrier Palmetto GBA issued on September 28. The draft LCDs represent Palmetto GBA’s efforts to identify the growing number of laboratory-developed molecular diagnostic assays and genetic tests.

In an exclusive interview with Dark Daily, Palmetto Medical Director Elaine Jeter, M.D., and Palmetto Vice President Mike Barlow explained the need for the new LCDs and offered insight into the process Palmetto GBA is developing to create a molecular test registry and a coverage determination and reimbursement process. This is an important development for the clinical laboratory industry. (more…)

Palmetto, Medicare’s Biggest Carrier, Proposes to End Code Stacking for Molecular Clinical Laboratory Tests

Palmetto wants to implement two proposed local coverage determinations (LCDs) on February 27, 2012

Medicare’s biggest local carrier is ready to tackle the problems created when clinical pathology laboratories use code stacks to submit claims for genetic tests  and molecular diagnostics assays. Medical laboratories in eight states served by this Medicare carrier are worried about its two draft proposals that could cut off reimbursement for large numbers of molecular diagnostic tests (MDTs) and laboratory-developed tests (LDTs), starting February 27, 2012.

The Medicare carrier is Palmetto GBA, of Columbia, South Carolina. On September 23, it shook up the clinical laboratory industry and pathology profession nationwide when it announced, in a “draft proposal” for a local coverage determination (LCD), that it would not allow labs to submit claims for most MDTs. As noted above, the proposed effective date is February 27, 2012.