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The test detects the HER2 biomarker in breast cancer and can be completed within the same day, allowing for faster results than other HER2 testing methods.
MaviDx will develop, validate, secure regulatory approvals for, and commercialize its SARS-CoV-2 and other infectious disease tests, including for influenza, on Veracyte's nCounter system.
The point-of-care test is based on technology developed at the Columbia University Fertility Center for preimplantation genetic testing.
Under the merger, Brava will operate as the in vitro diagnostics division of MBio, developing a portfolio of point-of-care tests for time-critical illnesses.
Both of the RT-PCR-based tests are designed to detect the SARS-CoV-2 nucleocapsid gene in a variety of swab samples and other specimens.
According to the agreement, Access Bio must sell at least 2 million tests by Sept. 30, 2021, to keep its exclusive rights in North America.
The assays are both designed to detect immunoglobulin M and G antibodies against SARS-CoV-2 in blood samples, with results in 10 minutes.
A number of diagnostic labs have considered saliva-based SARS-CoV-2 testing but decided against it, while other groups continue to pursue it.
BlackRock, the world's largest investment manager, led the round, joined by new investors Deerfield Management and Moore Strategic Ventures as well as existing investors.
The firm will use the proceeds to advance its liquid biopsy early cancer detection assay CancerSEEK in an FDA registrational trial.
New offerings from the oncology testing company include Inivita's InvisionFirst-Lung test and the NeoLab solid tumor test.
The funding package earmarks billions for the Public Health and Social Services Emergency Fund and Biomedical Advanced Research and Development Authority.
Enzyre is developing a near-patient platform called Enzypad to measure biomarkers in body fluids. The first application will be the monitoring of hemophilia.
A lab evaluation by the National Cancer Institute showed the company's SARS-CoV-2 IgG/IgM test to be sensitive and specific.
As reported in April, revenues for the fiscal year ended March 31 totaled £16.6 million ($21.4 million), up from £8.9 million in FY2019.
Caspr's assay can be transported at room temperature and performed without complex external equipment, making it ideal for low-resource environments.
The decline was largely due to decreased testing volumes as a result of the COVID-19 pandemic, although there was improvement in pharma services.
The test is designed to detect immunoglobulin G, M, and A antibodies against SARS-CoV-2 using a single drop of whole blood, plasma, or serum.
Unilabs Denmark, the local subsidiary of the European diagnostic services provider, will carry out antibody testing as part of the effort.
The autoimmune diagnostics firm attributed the decline to lower testing volumes amid the SARS-CoV-2 pandemic and a decrease in average reimbursement per test.