marketing clearance
FDA Grants Marketing Authorization for Invitae Hereditary Cancer DNA Sequencing Test
The Invitae Common Hereditary Cancers Panel is the first test of its kind to obtain FDA marketing authorization, creating an easier pathway for similar tests.
Singapore Clears New SARS-CoV-2 Assay for Clinical Use
A*STAR and Tan Tock Seng Hospital developed the test, which is the first diagnostic to be deployed in the country's hospitals since the outbreak began in December.
Pacific Biosciences Targets China Clinical Market to Rebound After Illumina Deal Falls Through
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PacBio will try to take the Sequel II to the clinic in China with the help of Berry Genomics and is open to partnerships globally, including with Illumina.
Roche Gains FDA Clearance for Cobas Babesia Blood Test
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
Centogene opened a Boston office in December and plans to open a lab there in a few months as it awaits an FDA decision on its clinical tool.