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The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.
The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.
Originally developed by Thermo Fisher Scientific, the test is modified for use on additional specimen types, including saliva, as well as with alternative nucleic acid extraction and amplification systems.
If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.
The panel can detect and differentiate SARS-CoV-2 and 20 other pathogens known to cause serious respiratory disease from nasopharyngeal swabs in symptomatic patients.
The test is the third to receive EUA, following tests from the CDC and New York state, and it runs on Roche's Cobas 6800 and 8800 systems.
The firm's AmplideX Fragile X Dx and Carrier Screen Kit is intended to help diagnose fragile X syndrome and assess parental risk of having a child with the syndrome.
The devices are used for collection and stabilization of saliva samples for genetic testing, such as diagnostic testing or direct-to-consumer use.
The firm said that with this clearance it now provides a comprehensive menu of VZV and HSV tests from swab and cerebrospinal fluid specimens.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.
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.