-
Washington Post |
Internal emails show that a military official started an inquiry with the FDA about Theranos's regulatory compliance years before the company's current travails.
Dec 2, 2015
-
Diagnostics World | Quanterix, the Lexington, Mass.-based creator of a high-throughput protein analysis instrument, is overhauling its hardware and software as it prepares for a more commercial stage in its development.
Nov 25, 2015
-
New York Times |
As the FDA continues to seek more authority to regulate laboratory developed tests, the agency has released information from 20 case studies of inaccurate or unreliable tests.
Nov 24, 2015
-
Diagnostics World | Thermo Fisher Scientific announced this week that it will be creating a next-generation sequencing test as a companion diagnostic in cases of non-small cell lung cancer, partnering with Novartis and Pfizer.
Nov 20, 2015
-
STAT |
After physician groups raised concerns about overdiagnosis and overtreatment of prostate cancer, fewer men are having PSA tests, with unknown results for public health.
Nov 20, 2015
-
Diagnostics World Boston Children’s Hospital has announced the results of the CLARITY Undiagnosed challenge, the second CLARITY crowdsourced competition sponsored by the Manton Center for Orphan Disease Research at Boston Children's and the Department of Biomedical Informatics (DBMI) at Harvard Medical School. CLARITY 2 exposed disparity in the ways variants are translated into medical findings, especially in particularly challenging cases.
Nov 17, 2015
-
Diagnostics World | The New England Journal of Medicine has published an opinion piece by Drs. Hardeep Singh and Mark Graber, calling for healthcare reforms to reduce the rate of diagnostic errors. According to a recent report by the Institute of Medicine, a typical American can expect to receive at least one misdiagnosis in the course of his or her lifetime.
Nov 11, 2015
-
Bio-IT World | Unveiling a next-generation sequencer with full automation from sample to answer, QIAGEN hopes that its flexible pricing and focus on ease of use will encourage a large number of small-to-midsize clinical labs to adopt in-house genetic testing.
Nov 10, 2015
-
Regulatory Focus |
The FDA has sent letters to DNA4Life, DNA-CardioCheck, and Interleukin Genetics informing them that it considers their genetic tests direct-to-consumer products that require regulatory clearance.
Nov 10, 2015
-
Milwaukee Journal Sentinel |
From glucose checks to drug tests, medical facilities perform thousands of tests without oversight. But a government check last year found that more than half of them failed to follow safe policies.
Nov 9, 2015
-
MIT Technology Review |
Sepsis affects more than a million people every year in the U.S. alone, and diagnosis can take five days. T2 Biosystems can cut the time to five hours.
Nov 4, 2015
-
Xconomy |
Milwaukee's TAI Diagnostics has raised $8.3 million to create a non-invasive blood test for heart transplant recipients that measures levels of cell-free DNA to gauge the risk of organ failure.
Nov 4, 2015
-
Bio-IT World | Direct Genomics of Shenzhen is bringing back the sequencing technology of the former Helicos Biosciences, hoping to give it a second life as an easy-to-use, multi-purpose diagnostic instrument.
Oct 30, 2015
-
Diagnostics World News Brief | The "Information is Power" initiative from Kailos Genetics and the HudsonAlpha Institute launches today. The first free test kits will be given out this evening at HudsonAlpha's Tie the Ribbons October breast cancer fundraising event, but men and women in Huntsville and Madison County, Alabama, can go online now to check their eligibility for free or discounted test kits.
Oct 29, 2015
-
Xconomy |
San Diego's Avelas Biosciences says today that UC San Francisco has begun enrolling women who face breast cancer surgery in a clinical trial for AVB-620, a diagnostic agent that helps surgeons differentiate cancerous tissue from healthy in real time.
Oct 29, 2015
-
Diagnostics World Today the Food and Drug Administration announced its intent to make autosomal recessive carrier screening exempt from premarket regulatory requirements. The notice was posted today online in the Federal Register and will be open for comment until November 27.
Oct 27, 2015
-
Diagnostics World News | True to her word yesterday, Elizabeth Holmes’ company, Theranos, has released a 16-page rebuttal to the Wall Street Journal article published last week.
Oct 22, 2015
-
The New York Times | The genetic-testing company stopped providing health information in 2013 after the F.D.A. ordered it to prove the accuracy of results. Now it will provide carrier status information on 36 diseases with FDA approval.
Oct 21, 2015
-
The New York Times |
The group says women should start having mammograms at 45 and continue yearly until 54; it previously recommended mammograms and clinical breast exams every year, starting at 40.
Oct 20, 2015