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The FDA also reissued Emergency Use Authorizations for SARS-CoV-2 tests from Roche and Express Gene to reflect their permitted use with additional sample types.
The ELISA-based test has shown 98.8 percent sensitivity and 99.6 percent specificity for detecting SARS-CoV-2 specific IgG against two virus antigens.
News items for the in vitro diagnostics industry for the week of Nov. 23, 2020.
The xT platform integrates structured clinical patient data with results from a 648-gene DNA panel and whole-transcriptome RNA sequencing.
The investment bank said it expects demand for Fulgent's COVID-19 testing to decline over the next two years.
Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems, which provide results in approximately 36 minutes.
Under the terms of the agreement, OpGen would sell $10 million in stock and warrants to a US-based healthcare-focused institutional investor.
For the three months ended Oct. 31, revenues rose to $1.48 billion from $1.37 billion in Q4 2019, beating the average Wall Street estimate of $1.4 billion.
The Warsaw, Poland-based firm has secured nearly €20 million ($23.7 million) this year to advance its PCR One point-of-care molecular diagnostic system.
Quest will provide Montefiore with services including hospital lab management and esoteric testing and both hospitals with supply chain management.
The Temple City, California-based firm has raised its full-year guidance for the third time this year and now expects 2020 revenues of $300 million.
The company stock will now trade on a split-adjusted basis on the Nasdaq after reducing its number of shares from 200 million to 26.7 million.
The kit is designed for use with samples stored in the company's CE-marked DNA/RNA Shield sample collection and preservation devices.
William Blair, Canaccord Genuity, and BTIG on Monday initiated coverage of newly public Biodesix, with ratings ranging from Buy to Outperform.
The firms said that the test would help Siolta identify and monitor patients eligible for its biotherapeutic therapy currently under development.
The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.
The total investment comes to more than $283 million for a program focused on COVID-19 testing of people disproportionately affected by the pandemic, the NIH said.
The company reported total revenues of RMB123.9 million ($18.2 million) for the quarter, driven largely by growth in its central laboratory business.
Ginkgo will offer Access Bio's antigen tests through its Concentric by Ginkgo service.
The company said that its Aptima HIV-1 molecular test utilizes a dual-target approach against highly conserved regions in the HIV genome.
News items for the in vitro diagnostics industry for the week of Nov. 16, 2020.
The firm CE marked its RespiFinder 2Smart kit for SARS-CoV-2 and MERS-CoV testing, as well as the RealAccurate Quadriplex Flu/COVID-19 PCR kit.
The company's AlloSure Kidney test received coverage, along with its AlloSure Heart test when used with the firm's AlloMap test.
Aspira said it will bring its experience in patient sample recruitment and ovarian cancer assay development to the collaboration.
Epic will access the center's liquid biopsy samples and expand its platform to in-depth characterization of cell-free fractions and circulating tumor cells.