TAG:
laboratories
Attorney Says Labs Face Increased Legal Liability
CEO SUMMARY: For many reasons, including cuts to lab test prices that health insurers pay, narrow networks, and more competition for lab test referrals, a significant number of lab companies are seeking ways to increase market share. These methods include the use of new laboratory test ar…
A coming transformation: Control over important diagnostic technologies is about to change hands
This is an excerpt from a 2,920-word article in the March 26, 2018, 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: He…
March 26, 2018 Intelligence: Late Breaking Lab News
On March 6, one of the lab industry’s long-serving executives and consultants, Jack Mattice, PhD, of Vancouver, Wash., died from flu complications. He was 77 years old. Mattice earned a PhD in medical microbiology from University of Oregon. Within a few years, he was handling mark…
D.C. Circuit Court Reverses Medical Necessity Ruling
MANY LAB EXECUTIVES were concerned last year after a judge in the District of Columbia Circuit Court ruled that clinical laboratories need to determine that all lab test services physicians order are medically necessary. The court also ruled that ordering physicians do not need to determine medical …
SEC Charges Theranos with ‘Massive Fraud’
CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could co…
FDA’s Gottlieb Favors Flexibility with LDTs, NGS
CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To d…
Why Pharma, Private Equity Want to Reshape Lab Industry
CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professio…
March 5, 2018 Intelligence: Late Breaking Lab News
“More people took genetic ancestry tests last year than in all previous years combined,” declared Senior Editor Antonio Regalado in a story published on Feb. 18 by MIT Technology Review. He wrote that, just in 2017, the number of people who had their DNA analyzed with direct-to-consumer genetic g…
ACLA Sues HHS, Claims Flaws In How CMS Set 2018 Rates
CEO SUMMARY: When the American Clinical Laboratory Association filed its lawsuit Dec. 11 against the Secretary of Health and Human Services, one of its main claims is that HHS collected payment data on the clinical laboratory testing business in a manner that was deeply flawed. HHS then u…
Sale of Tox Lab Company Attracted Multiple Buyers
CEO SUMMARY: In the midst of expanding their toxicology testing services nationally, DrugScan and DSI Medical Services (collectively Toxicology Holdings Inc.) hired a brokerage firm last year to pursue a sale of the two toxicology companies. Multiple potential buyers responded with intere…
CURRENT ISSUE
Volume XXXII, No. 13 – September 15, 2025
The Dark Report examines a new bill that would reform PAMA and avoid reimbursement rate cuts scheduled for January 2026. Clinical laboratory leaders are urged to make their voices heard in Congress. Also, an expert describes how labs can fix pre-analytical errors and avoid disaster.
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