By Mary Van Doren, from the Volume XXVI No. 12 – September 3, 2019 issue
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group.
CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In
By Joseph Burns, from the Volume XXVI No. 12 – September 3, 2019 issue
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to certain medications. Some pathologists and lab executives have criticized the FDA’s actions
By Joseph Burns, from the Volume XXV No. 17 – December 3, 2018 issue
IT’S AN ACQUISITION THAT BRINGS TOGETHER two different gene sequencing technologies into one firm. On Nov. 1, Illumina, Inc., announced an agreement to acquire Pacific Biosciences (PacBio) for $1.2 billion.
This deal will bolster Illumina’s already-dominant position in the market for DNA-sequencing machines. Wall Street analysts quickly pointed out that this gives Illumina control of two gene
By Robert Michel, from the Volume XXV No. 10 – July 9, 2018 issue
Wake Forest Baptist Medical Center of Wake Forest, N.C., has been notified by the Centers for Medicare and Medicaid Services (CMS), in a letter dated June 15, that it is back in compliance with Medicare Conditions of Participation. Earlier this year, following inspection of the hospital and its anatomic pathology department, federal and state officials identified
By Robert Michel, from the Volume XXV No. 10 – July 9, 2018 issue
CEO SUMMARY: This summer, both Geisinger Health and Sanford Health will introduce genetic tests designed specifically for use by primary care physicians in their daily practice. This is a significant milestone on the road to wider deployment of precision medicine services. In the case of Sanford Health, it plans to offer patients a $49 genetic
By R. Lewis Dark, from the Volume XXV No. 10 – July 9, 2018 issue
IT’S TIME FOR ALL CLINICAL LABS AND ANATOMIC PATHOLOGY GROUPS to pay closer attention to the advances in genetic medicine and precision medicine. Events are moving even faster than most experts have predicted.
As you will read on pages 3-4, two innovative health networks are on the verge of offering sophisticated genetic tests to patients visiting
By Joseph Burns, from the Volume XXV No. 7 – May 7, 2018 issue
CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery of its LIS and informatics specifically to enable
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
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
