February 29, 2016 Intelligence: Late Breaking Lab News

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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.”

TRANSITIONS

  • 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

dark_daily_logoHave 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.

 

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Screenshot 2016-03-04 13.12.52Brad Perkins, PhD Chief Medical Officer, Human Longevity, Inc.

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21st Executive War College

Conference on Laboratory & Pathology Management
April 26-27, 2016 • Sheraton Hotel • New Orleans, LA

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