TAG:
genetic test
Genetic Testing Genie Is Now Out of the Bottle
CEO SUMMARY: There’s been an uneasy standoff between companies that want to sell genetic tests directly to consumers over the Internet and both state and federal regulators. But now it appears that the FDA is ready to take off the gloves and assert greater control over genetic …
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…
June 21, 2010 “Intelligence: Late Breaking Lab News”
Early in June, exactly 96 customers of 23andMe, Inc., were notified that they had received the wrong genetic test results. It was particularly bad timing, since the company had just been sent a letter from the FDA asserting its authority to regulate genetic testing. Bloggers reported…
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…
Is Lab Industry Ready for Facebook and MySpace?
WHO COULD HAVE IMAGINED, JUST A FEW YEARS AGO, that social networking sites such as Facebook.com, MySpace.com, and YouTube.com would become a useful platform that allows clinical laboratories, pathology groups, and in vitro diagnostics (IVD) companie…
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 …
March 8, 2010 “Intelligence: Late Breaking Lab News”
On March 1, Omnyx, LLC, of Pittsburgh, Pennsylvania, licensed certain virtual microscopy and digital pathology patents from Olympus America, Inc. Omnyx is a joint venture between GE Healthcare and the University of Pittsburgh Medical Center …
Two New Pathology Models Will Soon Be Tried in Dallas
CEO SUMMARY: There are notable aspects to how and why four unlikely partners are banding together to invest $40 million and create the nation’s newest reference and esoteric testing laboratory. It was the pathologists at Baylor University Hospital in Dallas, Texas, who originated the vi…
Assessing the Year-End Financials For Nation’s Biggest Lab Companies
IN RECENT WEEKS, the last of the nation’s largest public laboratory companies released year-end 2009 financial reports. Each lab firm’s financial report provides useful insights about active trends in the lab testing marketplace, particularly in lab testing referred by office-based physicians. …
February 15, 2010 “Intelligence: Late Breaking Lab News”
In response to the sky-rocketing expenses associated with genetic and molecular testing, health insurers are planning ways to control both utilization and the prices at which these tests are reimbursed. For example, during the past year, Humana began using DNA Direct …
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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