TAG:
molecular assays
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…
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…
Our Top Ten Lab Stories Highlight Major Changes
CEO SUMMARY: What makes 2010 a watershed year for the laboratory testing industry is enactment of the 2,700-page Patient Protection and Affordable Care Act (PPACA). Even if parts of this bill are repealed, the remaining parts of the massive legislation will trigger major changes …
Systems Approach For Pre-Authorization Of Genetic Tests
CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there …
Labs Can Turn the Tables on the Payers
PRE-AUTHORIZATION OF GENETIC AND MOLECULAR TESTS is now on the radar screen of the nation’s larger health insurance companies. In most circumstances, payer pre-authorization requirements serve to exclude many smaller providers from access to patients. But local labs have a chance to guarantee their…
Payers Move to Pre-Authorize Expensive Genetic Tests
CEO Summary: Pre-authorization of expensive genetic and molecular tests is fast-becoming a priority for most of the nation’s health insurers. For clinical labs and pathology groups that don’t respond, this trend is a threat. On the other hand, because payers need all the skil…
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…
May 10, 2010 “Intelligence: Late Breaking Lab News”
Just four years since its founding in June, 2006, Aurora Diagnostics, Inc., of Palm Beach Gardens, Florida, is preparing to go public. On April 30, the company filed stock registration documents with the Securities and Exchange Commission (SEC) for an IPO (initial pu…
Preparing for New Lab Role In Personalized Medicine
CEO SUMMARY: Laboratory medicine is about to find itself between the two jaws of a powerful vise. One jaw is pending major legislative overhaul of the entire healthcare system, along with dwindling reimbursement as Medicare and Medicaid runs out of money. The other jaw is personalized med…
New Clinical Lab Trends To Shape Events in 2010
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long…
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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