BioCentury | Mar 9, 2018
Clinical News

FDA approves 23andMe's direct-to-consumer test for cancer risk

23andMe Inc. (Mountain View, Calif.) said FDA authorized its direct-to-consumer BRCA1/BRCA2 (Selected Variants) Genetic Health Risk (GHR) Report to provide patients with genetic information on their cancer risk. The approval, which came via FDA's de...
BioCentury | Mar 6, 2018
Company News

FDA approves 23andMe's direct-to-consumer test for cancer risk

23andMe Inc. (Mountain View, Calif.) said FDA authorized its direct-to-consumer BRCA1/BRCA2 (Selected Variants) Genetic Health Risk (GHR) Report to provide patients with genetic information on their cancer risk. The approval, which came via FDA's de...
BioCentury | Nov 7, 2017
Politics & Policy

FDA to exempt some genetic tests from premarket review

FDA implemented a new regulatory pathway for genetic health risk (GHR) assessments on Monday by classifying all GHR tests as low to moderate risk class II devices with “special controls.” By doing so, the agency...
BioCentury | Sep 12, 2017
Financial News

23andMe raises $250M round

23andMe Inc. (Mountain View, Calif.) raised $250 million in a venture round led by Sequoia Capital. Fellow new investors Euclidean Capital, Altimeter Capital and the Wallenberg Foundation also participated, along with existing investors Fidelity Management...
BioCentury | Apr 14, 2017
Clinical News

Personal Genome Service Genetic Health Risk (GHR) test regulatory update

FDA approved 23andMe's PGS Genetic Health Risk (GHR) test to assess genetic risk for 10 diseases and conditions. The approved indications are Parkinson’s disease (PD), late-onset Alzheimer’s disease (AD), celiac disease, alpha-1 antitrypsin ( AAT ;...
BioCentury | Jan 14, 2016
Translation in Brief

Pre-implantation improvements

As the debate heats up over the morals of using gene editing in human embryos to eradicate severe genetic diseases, many researchers are calling into play pre-implantation genetic diagnosis (PGD) and screening (PGS) as less...
BioCentury | Dec 21, 2015
Clinical News

CombiPGS regulatory update

CombiMatrix said the New York State Department of Health granted conditional approval to CombiPGS to increase implantation rates and reduce the rate of miscarriage in women undergoing in vitro fertilization (IVF). The preimplantation genetic screening...
BioCentury | Oct 26, 2015
Company News

23andMe sales and marketing update

23andMe relaunched its Personal Genome Service (PGS) in the U.S. with carrier tests included in the product. The company discontinued consumer access to its health-related genetic testing in December 2013 after it received a warning...
BioCentury | Oct 22, 2015
Company News

23andMe relaunches genome service in U.S.

23andMe Inc. (Mountain View, Calif.) relaunched its Personal Genome Service (PGS) in the U.S. with carrier tests included in the product. The company had discontinued consumer access to its health-related genetic testing in December 2013...
BioCentury | Feb 23, 2015
Clinical News

Personal Genome Service regulatory update

FDA approved a 510(k) under the de novo pathway for a single-condition health report for Bloom syndrome generated with the company’s Personal Genome Service (PGS). Bloom syndrome is an inherited disorder characterized by short stature,...
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