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The test targets antibodies for the viral spike protein and can characterize a vaccine-induced immune response.
Visby's test is a fully integrated PCR device that detects SARS-CoV-2 RNA, while SNIBE's test comprises assays for two different antibodies against the virus.
The tests will be developed to identify NSCLC patients with ALK fusions and EGFR Exon20 insertion mutations who respond to mobocertinib or brigatinib.
The test, which received EUA from the US Food and Drug Administration in April, is designed to detect human IgG antibodies in serum and plasma.
News items for in vitro diagnostics industry for the week of Sept. 14, 2020.
In 2018 Qiagen purchased a 19.9 percent stake in Ann Arbor, Michigan-based NeuMoDx along with the right to acquire the remaining shares.
The Manhattan-based lab will scale its capacity to process 20,000 tests per day by November and provide results dedicated to the city.
Ambry will provide RNA sequencing for Scipher's PrismRA blood test to predict response to TNF inhibitor therapies in rheumatoid arthritis patients.
The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.
AACC noted that the number of sites performing clinical lab testing in the US has risen to 266,000 in 2020 from 154,000 in 1993.