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Lab Innovators in Europe Have Solutions for USA
By Robert Michel | From the Volume XXXI, No. 13 – September 23, 2024 Issue
CEO SUMMARY: Rapid advances in a wide range of technologies over the past 15 years are enabling entrepreneurs to create transformative products for use by clinical laboratories and anatomic pathology groups. The Dark Report recently toured Europe to visit several such innovative companies…
Why Many Pathologists Are Cautious about Digital Path
By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue
CEO SUMMARY: In many major academic centers and the nation’s largest regional pathology supergroups, use of whole slide images and digital pathology workflow are accepted and established. This is often because of benefits unsupported by a pure return on investment. The clinical gains ou…
Watch Out Pathologists! They’re Coming for Histology!
By R. Lewis Dark | From the Volume XXXI, No. 11 – August 12, 2024 Issue
For any lab that depends on revenue from its histology labo…
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 …
Clarapath Automates Slide Prep, Microtomy Workflow
By Robert Michel | From the Volume XXXI, No. 9 – July 1, 2024 Issue
>>CEO SUMMARY: Histology is one area of laboratory medicine that utilizes a mostly manual work flow. However, pathology labs will soon have a novel solution designed to automate many of the steps in microtomy that produce glass slides. Reduced variability in the finished glass s…
ACLA President Van Meter Discusses LDT Lawsuit
By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue
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…
Lab’s Innovation Center Encourages Staff Ideas
By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue
CEO SUMMARY: At a time when health plans consider lab testing a commodity, the team at Sonora Quest Laboratories deliberately set out to encourage ideas and innovation from its staff by creating the “Innovation Center of Excellence.” One innovation involves helping health plans and ph…
Wisc. Diagnostic Lab’s Alternative Staff Solutions
By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue
CEO SUMMARY: Even as clinical laboratories and pathology groups around the nation cope with a sustained shortage of qualified staff, the team at Wisconsin Medical Laboratories has successfully kept staffing at 96% of authorized levels. One effective strategy they use is to go into the com…
Pathologist Paul A. Brown, MD, MetPath Founder, Dies at 85
By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue
EARLIER THIS YEAR, THE PATHOLOGY PROFESSION LOST one of what some call “the two Lions of Pathology.” On January 24, 2024, Paul A. Brown, MD, aged 85, died at his home in Palm Beach, Florida. In 1967, Brown was the founder of Metropolitan Pathology Laboratory, Inc., based in Ne…
Attorney Discusses Federal Cases Involving EKRA Violations by Labs
By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue
IT’S BEEN MORE THAN FIVE YEARS since Congress passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Lab managers and their attorneys quickly recognized that, whereas the Anti-Kickback Statute (AKS) has a safe harbor that permits percentage-based sales commissions to W2 employees, EKRA does…
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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