The authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.
The Strand Center for Genomics and Personalized Medicine lab is now accredited in India to perform three of Strand's most popular tests.
It is also the first such lab in China to be licensed by the State of California, allowing it to process samples from the state.
The firm has developed a platform for unbiased isolation of circulating tumor cells that allows follow-on genomic and other analyses of single cells.
The company's new clinical laboratory will provide interim and backup services for its customers.
It said the Hong Kong lab is the first in China to receive CAP accreditation.
The firm offers genetic testing services at its CLIA certified laboratory for pediatric, neonatal, and perinatal practitioners.
The laboratory will serve as the primary processor for the company's protein-based prostate cancer test called ProMark.
Invitae has received accreditation for its laboratory from the College of American Pathologists as well as coverage eligibility from Blue Shield of California and the Centers for Medicare and Medicaid Services.
NEW YORK (GenomeWeb News) – GATC Biotech today said that it has received ISO 17025 accreditation for its next-generation sequencing laboratories from Germany's national accreditation organization.
The US Food and Drug Administration has approved Alnylam's RNAi-based therapy Onpattro, according to Stat News.
Harvard Medical School's Seth Cassel and Cigall Kadoch argue in a Baltimore Sun op-ed that the recent TAILORx trial shows the potential of genomic-based medicine.
Researchers in the UK are working on using gene drives to control malaria-carrying mosquitoes, the Telegraph reports.
In PLOS this week: genetic architecture mediating gene expression, metabolomic patterns in multiple myeloma, and more.