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 SureDNA test “…is intended to collect saliva samples for DNA sequencing and reporting of patient information such as disease risks and likelihood of drug reactions.” Since 2010, the FDA has been sending similar warning letters to lab companies offering direct-to-consumer genetic tests. In 2013, a similar FDA letter to 23andMe made national news.
ADD TO: Sure Genomics
Sure Genomics launched earlier this month. It offers to sequence a whole human genome for $2,500. It says, “the price includes full DNA sequencing by a CLIA-certified lab, HIPAA-compliant data storage, ongoing reports, DNA re-analysis every six months, and one-hour consultation with a trained genetics professional. After the first year, a $150 annual subscription fee covers data storage and semi-annual DNA analysis against new and clinically validated markers.”
- Kenneth J. Bloom, MD, is now Head of Oncology and Immunotherapy at Human Longevity Inc., based in San Diego. He previously served at Clarient, Inc. and US Labs, and held clinical leadership positions at the USC School of Medicine, as well as Rush Presbyterian-St.Luke’s Medical Center.
- CellNetix Pathology & Laboratories, LLC, of Seattle, named Kathleen Fondren as its new CEO. Fondren had served as COO of CellNetix since August 2014. Prior to that, she held administrative positions for 27 years at Highline Medical Center in Burien, Washington.
- Asuragen, Inc., of Austin, Texas, appointed Colin Hill as its new Senior Vice President of Commercial Operations. Hill formerly was with Ortho Clinical Diagnostics, Siemens Healthcare, and Bayer Healthcare Diagnostics.
- Stanford University School of Medicine in Palo Alto, California, announced the appointment of Thomas Montine, MD, PhD, as the new Chair of the Department of Pathology, effective May 1. Montine is currently Chair of Pathology at the University of Washington.
Dark Daily Update
Have you caught the latest e-briefings from DARK Daily? If so, then you’d know that…
…a virus recently attacked the Royal Melbourne Hospital’s medical laboratory department computers, crippling workflow and spreading to other departments in the Australian hospital.
You can get the free DARK Daily e-briefings by signing up at www.darkdaily.com.
That’s all the insider intelligence for this report. Look for the next briefing on Monday, March 21, 2016.
BY DEMAND – Genome Sequencing & Genetic Medicine: How It’s Changing Healthcare and What Providers Can Expect Going Forward
With 24,000 whole human genomes sequenced, learn about new insights that inform clinical care
Here is a rare opportunity to understand how whole genome sequencing is poised to transform how we think about human health, and how that information will be used in medicine and healthcare.
Human Longevity, Inc., based in San Diego, has already sequenced 24,000 whole human genomes. In this exclusive session, you’ll hear from Brad Perkins, PhD, about how this innovative company is analyzing this genetic data and working with various partners in different scientific and medical disciplines.
This session will put you front and center in the technology race to understand the human genome and put that knowledge to work to improve patient outcomes and enrich the quality of life. A co-founder of Human Longevity, Inc., is C. Craig Venter, PhD, who was one of the first to sequence a whole human genome back in 2000. It is another reason why Dr. Perkins will have unique viewpoints to help you get the insider’s perspective on this vital topic. Register today and guarantee your place!
Conference on Laboratory & Pathology Management
April 26-27, 2016 • Sheraton Hotel • New Orleans, LA