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Visby's single-use, fully integrated assay is designed to detect SARS-CoV-2 nucleic acid in samples collected either by a healthcare provider or self-collected.

The Korean molecular diagnostics firm, a spinoff from genomic services provider Macrogen, also announced plans for an IPO early next year.

Before launching its COVID-19 test, which generated most of Co-Diagnostics' revenues in 2020, the firm's sales primarily came from mosquito-borne virus testing.

The labs will provide testing for K-12 schools by testing each consenting person in a classroom as one pool.

For the year ended Dec. 31, 2020, the firm reported revenues of $8.5 million compared to $19.2 million in 2019, beating the Wall Street estimate of $8.3 million. 

The agreement is with the Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Medical University Lodz.

The company's full-year revenues were $4.2 million, up 20 percent from the year-ago quarter.

The company's fourth quarter 2020 revenues were buoyed by sales of its SARS-CoV-2 testing-related products including transport media.

The company reported RMB133.9 million (US$20.5 million) for the quarter, up from RMB102.9 million in the same period of 2019.

The firm said that due to a negative coverage decision and capital constraints, it is evaluating options including a sale by a public takeover or an asset deal.

Earlier this year, Assure Tech's Ecotest COVID-19 serological rapid test for SARS-CoV-2 infection received authorization from Canadian regulators.

Oncgnostics also expects the test to be approved by regulators in Canada and to be sold there by the end of the year.

The chemiluminescent immunoassay may be used by laboratories CLIA-certified to perform moderate- or high-complexity tests, the FDA said.

The company is also working on a new Saphyr system that will have 14 times higher throughput than the current one, which can analyze 5,000 human genomes per year.

Although the logistics still need to be worked out, the partners hope to streamline oncologists' experience ordering tests that can inform patient care.

The hybridization-based test may provide better detection of emerging COVID-19 variants of concern, due to a higher tolerance for probe mismatches than in PCR.

Scipher will use the proceeds to further commercialize PrismRA, a molecular test intended to guide treatment decisions for patients with rheumatoid arthritis.

PWNHealth will be rebranded as Everly Health Solutions and will operate as an independent subsidiary of newly-formed parent company Everly Health.

The company was founded in 2017 to commercialize a small, battery-powered, disposable RT-PCR system called the Nuclein Hand-Held PCR Test.

NeoGenomics will offer Trapelo's clinical decision support system to providers, payors, and labs to aid precision oncology across all healthcare settings.

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