By Robert Michel, from the Volume XXV No. 18 – December 24, 2018 issue
CEO SUMMARY: This year’s list of the Top 10 Lab Industry Stories for 2018 is dominated by new directives from Medicare and private health insurers, as well as significant decisions by federal courts. Collectively, these developments create new compliance risks for all clinical laboratories and anatomic pathology groups. What is more notable about these top
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
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 Robert Michel, from the Volume XXIII No. 3 – February 29, 2016 issue
Sandy, Utah-based Sure Genomics is the latest genetic testing company to get a letter from the Food and Drug Administration asking why the company is marketing its SureDNA genetic testing kit to consumers without first obtaining clearance from the federal agency. The FDA sent the letter to Sure Genomics earlier this month and noted that the
By Robert Michel, from the Volume XXII NO. 11 - August 3, 2015Volume XXII No. 12 - August 24, 2015 issue
California is always in the forefront of states doing innovative things. It announced a public-private effort to develop a clinical lab- oratory assay that “will enable detection of all known pathogens with a single DNA sequencing test, to diagnose acute infections in hospitalized patients.”
By Joseph Burns, from the Volume XXI NO. 17 - December 15, 2014 issue
CEO SUMMARY: Cigna was the first national health insurer to require independent board-certified genetic counseling before approving coverage for certain genetic tests. Since launching this program in September 2013, the insurer has seen a 450% increase in genetic counseling for Cigna members. Such counseling has helped to reduce utilization of genetic testing because informed patients understand that a genetic test might not
By Robert Michel, from the Volume XXI NO. 5 – April 7, 2014 issue
CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements with Quest Diagnostics Incorporated and Laboratory Corporation of America. Both national lab
By Joseph Burns, from the Volume XX No. 11 - August 13, 2013 issue
CEO SUMMARY: Cigna launched a program that requires genetic counseling for patients and pre-authorization of genetic tests. Its partner is InformedDNA, a firm that provides genetic counseling services. The goals include better patient engagement, improved test utilization, and a process to evaluate the clinical effectiveness of new genetic tests. Cigna customers getting genetic tests for
By Joseph Burns, from the Volume XIX No. 8 - June 04, 2012 issue
CEO SUMMARY: In the national market for reference and esoteric testing, Cleveland Clinic Laboratories (CCL) is preparing to expand its presence. It has just moved into a $75 million state-of-the-art laboratory facility and wants to increase its outreach reference testing by four-fold within five years. A doubling of the national sales force is in the
By Joseph Burns, from the Volume XIX No. 2 - January 30, 2012 issue
CEO SUMMARY: Once again, Roche is hunting for gene sequencing and gene analysis technology that can support its goal of being a world leader in gene-based therapeutics and clinical lab testing that utilizes gene tests and molecular diagnostics. Last week, Roche launched a hostile stock tender offer for shares of Illumina, Inc., of San Diego,
