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The Clinitek Novus Automated Urine Analyzer uses dry-pad urine chemistry technology and a cassette test format to provide a variety of chemistry strip tests.
The company developed the test with labs at Emory University, Stanford University, the University of Cincinnati, and the University Health Network in Toronto.
The US Food and Drug Administration granted clearance to Diatron for an immunoassay that enables rapid screening for d-methamphetamine in human urine.
The assay provides comprehensive genomic information to oncologists from a blood draw, using targeted next-generation sequencing of circulating cell-free DNA.
The test, which is distributed in the US by Hardy Diagnostics, was found to have a low sensitivity for the IgM target.
The report also identified opportunities to improve adoption through dissemination of evidence supporting the clinical and economic utilization of testing.
Natera previously filed infringement lawsuits against ArcherDx around four other patents related to cell-free DNA detection in oncology.
The company said it broadened the scope of its life science products to include COVID-19 reagents used by manufacturers to develop rapid antigen tests.
Tangen will use the proceeds to scale up manufacturing for its SARS-CoV-2 point-of-care test and accelerate development of a panel test including SARS-CoV-2 targets.
The company said that it has priced a public offering of 2,651,108 shares of its common stock at $32 per share.
News items for the in vitro diagnostics industry for the week of August 3, 2020.
The firm also announced two new instruments that would diversify its product offerings.
NantHealth's net loss more than tripled in the second quarter, though it continues to build up its cash reserves.
The firm said that its financial results for the second quarter of 2020 reflected the impact of an FDA revocation of an EUA for its DPP COVID-19 IgM/IgG System.
Although its research test volume decreased significantly because of the COVID-19 pandemic, the company saw revenue growth across both clinical testing and development services.
The Beijing-based company, which went public in the US in June to raise $235.0 million, specializes in genomic products and services for cancer.
The companies are validating the Genedrive 96 Sars-CoV-2 kit using saliva samples extracted with Beckman Coulter's RNAdvance viral extraction chemistry
The sequencing-based test for minimal residual disease can be use with blood and bone marrow samples in patients with chronic lymphocytic leukemia.
The firm will use the proceeds to support commercialization, regulatory, and product development activities, as well as for general working capital purposes.
The firms are using the technology, previously employed by Biocept exclusively for blood-based cancer testing, to develop a highly sensitive COVID-19 diagnostic.
Factorial will use InCellDx's new IncellMax-Seq reagent to perform in situ library preparation for next-generation sequencing applications.
DiaSorin said its Liaison Testosterone xt test enables the detection of fertility disorders, such as hypogonadism in men and hyperandrogenism in women.
Issued this week, the proposed fee schedule would cut overall pathology service payments by 9 percent compared to 2020 and independent lab services by 5 percent.
The company missed analyst estimates on the top line and provided guidance for its full fiscal year 2020 revenues to decrease 2.5 to 3.0 percent as reported.
The agreement aims to develop and validate a scaled-up manufacturing process to enable the production of millions of tests per month.