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The designation will enable the South Korea-based squencing services provider to perform NGS analysis of clinical trial samples.
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.
Two COVID-19 vaccine developers have released their trial protocols to build public trust, the New York Times reports.
A new analysis finds the rapid COVID-19 test from DnaNudge to be highly accurate, Reuters reports.
In Science this week: global citizens' assembly on genome-editing technologies proposed, epigenetic markers predict metformin response, and more.
According to the Verge, many US states are not including positive results from rapid COVID-19 testing in their case numbers.