TAG:
molecular diagnostic test
Medicare Carrier Plans to Reject Molecular Claims
CEO SUMMARY: In September, Palmetto, a Medicare carrier serving California and seven other states, made public two draft local coverage determinations (LCDs) that revamp its coverage guidelines for molecular diagnostic tests (MDT) and laboratory-developed tests (LDT). All labs su…
Economics of Lab Testing to Be Challenged
BY ANY MEASURE, 2012 IS SHAPING UP TO BE A YEAR OF MAJOR CHANGE for healthcare and the clinical laboratory testing industry. Unfortunately, an early reading of the tea leaves indicates that the outcomes are not likely to be favorable for most clinical laboratories and anatomic pathology groups. Letâ…
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. …
Clarient, Generation Health, GenMark, Osmetech, Laboratoire Cerba, UCLA Med Center
CLARIENT INKS PACT WITH GENERATION HEALTH FOR GENETIC TESTING PAYER PRE-AUTHORIZATION OF GENETIC TESTS is the reason for the newly-announced contract between Clarient, Inc., and Generation Health, Inc., of Upper Saddle River, New Jersey. An…
French Company Buys Pittsburgh-Based RedPath
CEO SUMMARY: Here’s a deal that is all about proprietary molecular assays and access to new markets. With its purchase of RedPath Integrated Pathology, ExonHit Therapeutics, S.A., of Paris, France, gains a CLIA laboratory and access to the U.S. market, even as the new owner ope…
Pre-authorization Coming For Pricey Molecular Tests
CEO SUMMARY: In response to the steep ramp-up in the utilization of genetic and molecular testing, the nation’s largest health insurers are preparing to institute new guidelines for coverage and reimbursement. These will include pre-authorization by physicians, a more effective genetic …
GSK and Abbott Team up For Companion Diagnostic
CEO SUMMARY: Although GlaxoSmithKline PLC is several years away from having a deliverable product from its Antigen Specific Cancer Immunoassay (ASCI) Program, it has a development deal with Abbott Laboratories to produce a companion diagnostic test for ASCI-based products. The in…
Lab M&A Deals in June Show Market Direction
CEO SUMMARY: Despite a dismal economy, the month of June spawned two interesting merger/acquisition transactions in the lab testing industry. In one case, a blood brother gobbled up a specialty diagnostics company. In another transaction, two cross-town neighbors in Kansas City m…
New Flu Strain Expected In Upcoming Flu Season
CEO SUMMARY: Public health labs continue to monitor for new cases of the A/Novel H1N1 flu, while preparing for what may be a difficult flu season this fall. Having coped with a 10-fold increase in testing volume, public health labs are assessing the lessons learned from the April…
CBL Path, Plus Diagnostics, Alpha Innotech, DNA Direct, Humana
NEW PATHOLOGY LABS OPEN ON EAST COAST TIMES MUST BE GOOD for anatomic pathology companies—at least two companies have each announced the opening of a new laboratory facility. On the East Coast, it was CBL Path, Inc., of Rye Brook, New York, which expanded. On May 29, it 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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