TAG:
molecular pathology
Clinical Labs Bidding Up Lab Director Salaries
CEO SUMMARY: There’s great news for pathologists and PhDs with expertise in molecular and genetic testing. Salaries are on the rise as more clinical labs build up their molecular and genetic testing programs and need talent to implement and supervise this activity. One experienced medic…
Mount Sinai Health System Sells Outreach Lab to LabCorp
ANOTHER ACADEMIC MEDICAL CENTER decided to cash in on the value of its outreach lab. On Jan. 10, Laboratory Corporation of America announced it would acquire the lab outreach business of Mount Sinai Health System of New York City. Terms of the transaction and purchase price were not disclosed. The…
OIG Comments on PAMA Plan and Exclusion of Many Labs from Reporting
ON THE SUBJECT OF LAB TEST MARKET PRICE REPORTING as required under PAMA, many clinical laboratory executives, pathologists, and industry experts see deep flaws in the process the federal Centers for Medicare & Medicaid Services has established. Yet, CMS itself seems blind to the…
ADLT Final Rule Creates Tough Questions for Labs
IT’S GOING TO BE A DIFFERENT AND TOUGHER WORLD for laboratory companies that market proprietary molecular and genetic tests. That’s the opinion of experts who have studied the final rule governing Advanced Diagnostic Laboratory Tests (ADLTs) that the federal Centers for Medicare & Med…
Understanding the Future Of Laboratory Medicine
CEO SUMMARY: Healthcare’s transformation is now far enough along that most clinical labs and pathology groups are either feeling the financial pain or are excitedly developing ways to deliver more value from lab testing services. On April 26-27, at the 21st annual …
FDA Steps Up Test Enforcement, Saying Tests Need Clearance
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Palmetto GBA Issues Guidance On Billing NGS Test Panels
CEO SUMMARY: Across the lab industry, next generation sequencing is taking hold as an effective and efficient testing platform. In response, payers are developing coding and payment policies that may affect the finances of clinical labs. Last month, Palmetto GBA, a Medicare contractor, is…
Despite Tough Anatomic Pathology Market, Bostwick Opens New Laboratory
CEO SUMMARY: Once again, entrepreneur and pathologist David G. Bostwick, MD, is starting up a new lab company. Granger Diagnostics is now open and is located in North Chesterfield, Virginia. It is designed to be an anatomic, clinical, and molecular pathology reference laboratory. In an ex…
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…
Labs React with Criticism to Proposed ADLT Rule
CEO SUMMARY: Some in the lab industry had high hopes that passage of the Protecting Access to Medicare Act (PAMA) last year would favorably resolve a number of important issues. However, those hopes were dashed following the September 25 release by CMS of a proposed rule setting out how i…
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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