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Invitae’s Troubled Journey: Rise, Fall, and Bankruptcy
By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue
ON MAY 7, THE REMNANTS OF GENETIC TESTING GIANT INVITAE (NYSE: NVTA) were scooped up by …
New CISA Draft Rule Mandates Rapid Reporting of Cyberattacks
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: There is another federal rule that will require compliance by clinical labs. An agency of U.S. Dept. of Homeland Security published a draft rule on April 4 that requires certain organizations—including hospitals, clinical labs, and pathology groups—to report, within 72 ho…
Change Healthcare Hit by Major Cyberattack
By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue
CEO SUMMARY: It was a classic ransomware attack against Change Healthcare, the business unit of Optum that is itself a division of UnitedHealth Group. On Feb. 21, this cyberattack shut down critical systems at Change Healthcare, such as those involved in accepting and forwarding prescript…
Genetic Testing Firm Invitae Files Chapter 11 Bankruptcy, Pursues Sale
By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue
INVITAE CORP., A MEDICAL GENETICS COMPANY, got the go ahead in mid-February from the U.S. Bankruptcy Court for the District of New Jersey “to find a buyer and exit from Chapter 11 by late July,” Reuters reported. Invitae said in a news release that it…
Lab News Briefs
By Robert Michel | From the Volume XXXI, Number 1 – January 16, 2024 Issue
Siemens to Explore Sale of Its IVD Diagnostics Unit Siemens Healthineers, Erlangen, Germany, is reportedly looking into options for sale of its in vitro diagnostics (IVD) segment. The company’s “review co…
Layoffs at Major Health Plans Slow Processing of Lab Claims
By Virchow | From the Volume XXXI, Number 1 – January 16, 2024 Issue
…
Lab News Briefs: Joint Commission, Bon Secours, Anthem, Walmart
By Scott Wallask | From the Volume XXX, No. 13 – September 11, 2023 Issue
Joint Commission Looks at Cyberattacks The Joint Commission issued a Sentinel Event Alert for hospitals to address cyberattacks. The alert pr…
With Z-codes, Will Other Payers Follow UnitedHealthcare’s Lead?
By Virchow | From the Volume XXX, No. 11 – July 31, 2023 Issue
EDITOR’S NOT…
Siemens Healthineers Plans to Streamline Product Offerings
By Scott Wallask | From the Volume XXX, No. 1 – January 3, 2023 Issue
DURING A 15-MONTH STRETCH FROM 2006-2007, Siemens Healthineers spent $14 billion to acquire three competing companies and their various technologies. Today, Siemens is preparing to sunset as many as half of its legacy instruments and assays, whic…
Ravgen Gets $272.5 Million Verdict against Labcorp
By Scott Wallask | From the Volume XXIX, No. 15 – October 31, 2022 Issue
CEO SUMMARY: In September, a jury returned a $272.5 million verdict against Labcorp, representing royalties owed to biotech company Ravgen for infringement of its diagnostic genetic test patent. Soon after, Quest Diagnostics settled a similar lawsuit with Ravgen before its tri…
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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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