TAG:
molecular diagnostic tests
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…
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…
Genome Sequencing Promises to be Disruptive
EVERYONE SHOULD CAREFULLY READ OUR LEAD STORY ON THE FACING PAGE. Titled “Rapid Gene Sequencing Predicted by Mid-2009,” it is a revealing look at the declaration of California-based Complete Genetics that, in less than eight months, it will begin delivering full human genome sequ…
Phlebotomist Gibson Steals Patient’s Identity
CEO SUMMARY: It was a case of a well-liked lab worker acting in rogue fashion to steal and use the identity of a patient to commit financial fraud. Within laboratories, employees in phlebotomy, accessioning, data entry, coding, billing, and collections often have access to sensitive patie…
Evolution in Pap Marketplace Shows Impact of New Guidelines
NEW GUIDELINES for cervical cancer screening issued last year are fueling strong growth in the sales of Digene Corporation’s HPV test. For its fiscal second quarter that ended on December 31, 2004, Digene reported sales of $27.0 million. That’s a 28% increase from Digene’s sal…
“State of Industry” Report On Molecular Diagnostics
CEO SUMMARY: Enterprise Analysis Corporation has launched an ambitious survey that will include 150 laboratories performing molecular testing in the United States. Last week it released information about the first 51 labs contacted in this effort. The survey provides an intriguing look at…
Luminex Test Technology Entering Clinical Usage
CEO SUMMARY: Multi-analyte diagnostic testing is moving closer to widespread clinical usage. During the past 12 months, several of the nation’s largest laboratory companies have begun to use Luminex Corporation’s LabMAP™ system to generate patient test results. At the same time, the…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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