TAG:
clia
FDA Clears Waived CBC For Near-Patient Testing
CEO SUMMARY: Market clearance of the first-ever CLIA-waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer Sysmex America, Inc., foresees…
Lab Scheme Recruits Hospitals To Bill as In-Network Providers
CEO SUMMARY: Management companies using a new generation of potentially fraudulent schemes are targeting hospitals and health systems for arrangements that use questionable means to increase lab test volume and revenue. The management companies often use the term “hospital outpatient de…
Drug Testing Labs in Texas, California Deal With Fraud Charges
CEO SUMMARY: Two toxicology lab companies accused of fraud are fighting to stay in business. In the case of Medicus Laboratories of Dallas, it is asking a federal judge to issue a temporary restraining order to prevent state and federal lab regulators from pulling its CLIA license. At Pro…
Proove Biosciences, Medicus Face Serious Fraud Charges
This is an excerpt from a 1,400-word article in the Sept. 18, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. …
Invitae genetics lab to retest 50,000 patients after finding errors
This is an excerpt from a 1,400-word article in the August 28, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: In…
50,000 Patients to Retest After Invitae Finds Errors
CEO SUMMARY: In recent weeks, a client notified Invitae of discordant results on a patient. The notification caused the genetic testing company to discover it had a systemic error that failed to test for a specific rare mutation associated with inherited cancer. Company officials believe …
UnitedHealth to Start Gene Test Pre-Approval
CEO SUMMARY: With programs now at the nation’s two largest insurers, is it possible to argue that prior-authorization is going mainstream? Some observers say, yes, as THE DARK REPORT predicted. What is certain is that starting Nov. 1, UnitedHealthcare is requiring prior authorization fo…
Lab’s Low Gene Test Price Gets Insurers’ Attention
CEO SUMMARY: At a time when most molecular and genetic testing companies are struggling to gain coverage for their tests, this Silicon Valley-based lab company has become an in-network lab provider for a number of health insurers—including three of the nation’s largest payers. It did …
Mississippi Blue Cross Sues Hospital, Tox Labs
CEO SUMMARY: Last month’s lawsuit filed by Blue Cross Blue Shield of Mississippi against a small rural hospital in Mississippi and multiple defendant lab companies in Texas is the latest attempt by health insurers to rein the widespread fraud that threatens to overwhelm the pain managem…
California company shows labs the way with low genetic testing cost
This is an excerpt from a 1,485-word article in the June 5, 2017 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: At a time when most molecular and gene…
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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