By Robert Michel, from the Volume XXV No. 13 – September 10, 2018 issue
News that a laboratory’s courier truck was high-jacked in broad daylight with patient specimens aboard puts the spotlight on whether the security practices labs use to protect drivers, vehicles, and the patient specimens they may be carrying are adequate. On Aug. 3 in Durham, N.C., a driver of a courier vehicle owned by Laboratory Corporation of
By Robert Michel, from the Volume XXV No. 12 – August 20, 2018 issue
There is a new sector in the clinical laboratory industry. It is called “global direct-to-consumer (DTC) genetic health testing” by Kalorama Information, a market research firm based in Rockville, Md. In a recent report, Kalorama says this sector is comprised of the direct-to-consumer genetic tests which are initiated by the consumer, meaning that the consumer decides
By Joseph Burns, from the Volume XXV No. 8 – May 29, 2018 issue
CEO SUMMARY: Reporting in The Wall Street Journal shows that some physicians in Arizona were concerned about the harm from erroneous test results from Theranos Inc. But those physicians who expressed concern may have been only a small set of the number of physicians who were worried about patient harm. After reviewing the concerns about
By Joseph Burns, from the Volume XXV No. 8 – May 29, 2018 issue
CEO SUMMARY: While Theranos was a darling of the business and national media, Wall Street Journal reporter John Carreyrou was hearing troubling reports about patients who got incongruent lab results that put them at risk for inappropriate medical treatments. His investigation of Theranos and its celebrated founder, Elizabeth Holmes, revealed that the company’s much-touted lab
By Joseph Burns, from the Volume XXV No. 6 – April 16, 2018 issue
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible
By Joseph Burns, from the Volume XXV No. 6 – April 16, 2018 issue
CEO SUMMARY: Several developments have moved the case forward since December when the American Clinical Laboratory Association filed suit in federal court against the Department of Health and Human Services. Inrecent weeks, ACLA filed for summary judgment; HHS responded with its own request for summary judgment; and most recently ACLA filed its rebuttal to the
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: Here’s the first look for the lab industry at an important
By Joseph Burns, from the Volume XXV No. 5 – March 26, 2018 issue
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 professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access
By Joseph Burns, from the Volume XXV No. 4 – March 5, 2018 issue
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 used that flawed data to set payment rates
This is an excerpt from a 5,000-word article in the January 22, 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: UnitedHealth made national news when it filed a $100 million lawsuit against
