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Vela anticipates CE-IVD marking for an automated version of its test, and JN Medsys has received authorization for its test in Singapore and the Philippines.
The funding will support validation of an assay for both manual and high-throughput automated workflows.
The test is a probe-based reverse transcription PCR test for detecting the coronavirus by targeting conserved regions of its genome.
News items for the week of Feb. 3, 2020.
It is the first time that the agency has authorized for marketing a next-generation sequencing test for HIV-1 resistance, the FDA noted.
The test detects genomic drug resistance mutations in HIV-1 that can lead to treatment failure and is validated on the firm's automated Sentosa workflow.
Vela purchased Great Basin for $1.4 million in June, and will reopen its Utah-based lab, rehire employees, and commercialize the firm's infectious disease platform.
The acquisition nets Vela a US manufacturing and R&D site, as well as Great Basin's multiplexing platform and six existing FDA-approved products.
The company, which also said it is short on funds, may have to pay $18.3 million to Hudson Bay Master Fund if forebearance is not granted for the default.
The firm said that a number of hospitals and labs are expected to evaluate the panel, presenting it with about a $2.0 million annual revenue opportunity.
New analyses indicate female researchers are publishing less during the coronavirus pandemic than male researchers, according to Nature News.
A study suggests people with the ApoE e4 genotype may be more likely to have severe COVID-19 than those with other genotypes, the Guardian says.
Direct-to-consumer genetic testing companies are searching for a genetic reason for why some people, but not others, become gravely ill with COVID-19, the Detroit Free Press reports.
In PNAS this week: forward genetics-base analysis of retinal development, interactions of T cell receptors with neoantigens in colorectal cancer, and more.