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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.
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 company presented new evidence for the sensitivity of its multi-cancer early detection test and robustness of its automated library prep system.
The company reported total revenues of RMB123.9 million ($18.2 million) for the quarter, driven largely by growth in its central laboratory business.
The company said that its Aptima HIV-1 molecular test utilizes a dual-target approach against highly conserved regions in the HIV genome.
The group noted that while molecular diagnostics are powerful tools, physicians' enthusiasm for such tests can lead to improper and excessive use.
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.
As adoption of personalized medicines has accelerated over the last four years, so has the number of marketed genetic and exome tests.
At an AMP virtual meeting workshop, a Mayo Clinic lab director offered advice on what diseases to include, how to handle VUSs, and other considerations for ECS.
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.
The firm said it will dispute the claim of overpayment and will separately negotiate with the undisclosed payor for in-network status.
In a conversation at the Association for Molecular Pathology meeting, the directors touched on topics such as test allocation and staffing and reagent shortages.
The test will identify patients with squamous cell head and neck cancer caused by specific HPV infections for treatment with BioNTech's investigational BNT113.