TAG:
LabCorp
Quest Diagnostics Moves to Acquire LifeLabs of Canada
QUEST DIAGNOSTICS, ALREADY A CLINICAL LABORATORY BEHEMOTH IN THE U.S., is expanding its Nor…
Invitae’s Troubled Journey: Rise, Fall, and Bankruptcy
ON MAY 7, THE REMNANTS OF GENETIC TESTING GIANT INVITAE (NYSE: NVTA) were scooped up by …
New Type of Competition from Investor-Owned Labs
CEO SUMMARY: More investor-funded lab companies see robust future growth in serving what The Washington Post calls “a booming online wellness market that aims to leave the doctor’s office behind. ” This is a new market driven by younger health care-minded consumers who turn to …
Is It Time for Clinical Labs to Embrace Consumers?
HEALTHCARE IN THIS COUNTRY HAS A WELL-D…
ACLA Files Court Challenge to FDA’s Final LDT Rule
CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.” ACLA and HealthTrackRx are challenging the FDA’s  
ACLA President Van Meter Discusses LDT Lawsuit
CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…
June 10, 2024, Intelligence: Late-Breaking Lab News
Once a high-flier lab test manufacturer with a market valuation of $2 billion, Cue Health of San Diego filed for Chapter 7 bankruptcy on May 28. Analysts now say the company is valued at about $15 million. Founded in 2010, Cue Health was developing a test system that consumers could …
Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule
BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…
Labcorp to Acquire Only Certain Lab Assets of OPKO’s BioReference
Following Labcorp’s announcement that it will acquire “select assets” of BioR…
April 29, 2024, Intelligence: Late-Breaking Lab News
It may be that the genetic data cat is out of the bag already. Nonetheless, lawmakers in Delaware are considering a bill that—among other things—would prevent life insurance companies from buying or using genetic testing data if it was obtained from ancestry companies and not from medical records…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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