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The assay kit also received interim authorization from Health Canada on Jan. 21 and will be used by a large Canadian provincial authority.
While the tests from Clinomics, UPenn, and Inno Diagnostics detect the SARS-CoV-2 virus, Princeton BioMeditech's test differentiates between SARS-CoV-2 and influenza.
Mologic will help Avacta secure CE marking for one of its SARS-CoV-2 tests, as well as assist it with test manufacturing and distribution.
Roche Diagnostics obtained a claim expansion for its Cobas CT/NG assay, which uses real-time PCR to detect Chlamydia trachomatis and Neisseria gonorrhoeae DNA.
In an SEC filing, the firm said it intends to use the IPO proceeds to support manufacturing and establish a sales and marketing team, among other activities.
BD is reinvesting some of its $668 million Veritor Dx windfall into expanding the menu for a newly tripled installed base.
With new platforms in its plans, Accelerate will target hospitals that have a bacterial identification method but want to add rapid susceptibility testing.
The company said it intends to use the technology to develop infectious disease diagnostics, with an initial focus on SARS-CoV-2.
For the fourth quarter, diagnostics sales increased 20 percent to CHF 4.13 billion from CHF 3.44 billion in the same quarter in 2019.
The firm attributed the revenue growth in part to $867 million in sales of molecular and antigen diagnostics for COVID-19.
The company said it has priced a public offering of 3,571,428 shares of its common stock at $70.00 per share.
The RT-LAMP-based platform, which the researchers plan to commercialize through a spinout company, could be adapted for other infectious disease tests.
The firm said that hospitals and private laboratories in key European markets will now be able to run the tests on the firm's Vidas 3 fully benchtop system.
The firm said its Protein Sciences and Diagnostics and Genomics segments each saw record organic growth of 19 percent for the quarter.
The test, a version of the company's rapid SARS-CoV-2 assay, will be designed for both point-of-care and at-home use as an over-the-counter product.
The test was the first OTC at-home test for the coronavirus to receive EUA from the FDA in December. The US will procure 8.5 million tests.
The firm said its Diagnostics fiscal Q1 revenue rose in part because of the increase in antigen test sales while routine testing also returned to normal levels.
The funding supports the development of a four-hour electrochemical antimicrobial sensitivity test that can be used with commercially available panels.
The company cited its revenue increase to high demand for its SARS-CoV-2 testing products and the acquisition of a PCR instrument manufacturing partner.
For the first time, WHO's essential diagnostics list includes tests that it recommends should also not be supplied because they are unreliable, among other reasons.