TAG:
molecular diagnostic
“Primary-Care Pathology” One Goal at Beth Israel
CEO SUMMARY: In a pioneering collaboration, the pathology department at Beth Israel Deaconess Medical Center in Boston, Massachusetts, will work with GenomeQuest, Inc., to perform whole genome sequencing of tumor specimens. GenomeQuest will handle sequencing, assembly, and annota…
Lab Industry Unprepared For FDA Action on LDTs
CEO SUMMARY: News stories about the FDA’s stated intention to regulate laboratory-developed tests (LDTs) generally play up the agency’s comments about the need to assert regulatory oversight of genetic tests and direct consumer access testing. But what has gone unremarked by …
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…
September 13, 2010 “Intelligence: Late Breaking Lab News”
Researchers at North Carolina State University are developing a method that might make it possible to diagnose and treat cancer through the use of special microneedles they developed. NCSU researchers use the microneedles to deliver nanoscale dyes based on quantum dots to locations u…
August 23, 2010 “Intelligence: Late Breaking Lab News”
With the goal of developing biomarkers useful in diagnosing a variety of cancers, Pathwork Diagnostics, Inc., and Novartis AG announced a research partnership on July 30. It is an early example of a collaboration between a diagnostics company and a pharmaceutical com…
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…
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…
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 …
Baylor Pathologists Form Lab with US Oncology
CEO SUMMARY: In Dallas, Pathologists Bio-Medical Laboratories is part of a new laboratory partnership that includes Baylor Health Care System, Texas Oncology, and US Oncology. The four partners ponied up a total of $40 million in cash and debt to build a state-of-the art laboratory in a 1…
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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