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In Brief This Week:, Bio-Techne, DermTech, Cue Health, DiaSorin, Devyser, More

NEW YORK – Bio-Techne announced this week that Wilson Wolf Manufacturing has met the requirements to trigger Bio-Techne's initial $257 million investment in the company, which will close at the end of March. The investment will give Bio-Techne a 20 percent ownership stake in Wilson Wolf and the agreement includes the right to acquire the remaining ownership for $1.0 billion upon Wilson Wolf’s achievement of $226 million in trailing 12-month revenue or $136 million in earnings before interest, taxes, depreciation, and amortization. If that milestone isn’t met by Dec. 31, 2027, Bio-Techne has the right to acquire the firm for about four times its trailing 12-month revenue. 

DermTech this week reported its Q4 and full-year 2022 financial results, saying that total Q4 revenue declined 5 percent year over year to $3.0 million from $3.2 million. Assay revenue was $2.7 million, down 9 percent from $3.0 million in Q4 2021 due primarily to changes in collection estimates for tests run in prior periods, the firm said in a statement. Net loss for the quarter was $28.2 million, or $.93 per share, up compared to a loss of $26.1 million, or $.88 per share, in Q4 2021. Full-year total revenue rose 23 percent to $14.5 million compared to $11.8 million in 2021, while assay revenue was up 25 percent to $13.8 million from $11.0 million. Net loss was $116.7 million, or $3.88 per share, increasing from $78.3 million, or $2.71 per share. 

Cash, cash equivalents, restricted cash, and short-term marketable securities totaled $129.8 million as of Dec. 31. The company said it believes it has sufficient cash and the ability to access capital to fund its current operating plan through the third quarter of 2024. 

DermTech also announced that President and CEO John Dobak will leave the company, effective when the board of directors appoints a successor or Sept. 30, 2023, whichever is earlier. 

Cue Health announced this week that it is collaborating with Pfizer to increase awareness about severe COVID-19 and encouraging people to seek treatment if they test positive. People will be able to use the Cue Health App via the Cue Care test-to-treat platform to access educational resources from Pfizer, such as information on risk factors for progressing to severe illness. Cue said in a statement it plans to add educational resources about other respiratory viruses and sexual health conditions in the future. 

Devyser said this week that it has received certification under the In Vitro Diagnostic Regulation for its Devyser Compact, a test for detecting chromosomal abnormalities. The firm is launching the test, which is its first IVDR-certified product. The IVDR certification also covers Devyser's quality management system. The IVDR went into effect in May 2022. 

Devyser Compact was originally launched in 2006. It detects the most common syndromes, including Down syndrome, as well as Turner syndrome. It became available in English-speaking countries starting Wednesday and will become available elsewhere throughout March, Devyser said. 

DiaSorin said this week that its Luminex subsidiary has completed the sale of its flow cytometry and imaging business unit to Cytek Biosciences for approximately $46.5 million. The deal, announced last month, helps DiaSorin achieve its goal of focusing on its core business going forward. 

Molecular diagnostics firm OpGen of Rockville, Maryland, said this week that its infectious disease subsidiary Ares Genetics has completed its move from an incubator space to a 5,000-square-foot facility in Vienna, Austria. The new location is expected to help Ares further grow its product and next-gen sequencing service business. 

CorDx said this week that its CorDx COVID-19 Ag Test has been approved for use by Singapore's Health Sciences Authority. The lateral flow immunoassay qualitatively detects the nucleocapsid protein antigen from the SARS-CoV-2 virus and is for at-home use. The test, which delivers results in 10 minutes, received Emergency Use Authorization from the US Food and Drug Administration in November. 

Applied BioCode this week reported fourth quarter revenues of $4 million, up 9 percent year over year; and full-year 2022 revenues of $13 million, up 13 percent year over year. The company said that revenue growth was driven by increasing demand in its multiplex in vitro diagnostic panels, including the US Food and Drug Administration 510(k)-cleared Gastrointestinal Panel (GPP) and Respiratory Panel (RPP), sales of which grew 57 percent and 94 percent year over year, respectively. In Q4, GPP sales grew 20 percent compared to the prior-year period, while RPP sales more than quadrupled, Applied BioCode said. Both products use the company's proprietary platform technology, Barcoded Magnetic Beads (BMB), in conjunction with its FDA-cleared high-throughput BioCode MDx-3000 molecular system, which can process 96 samples simultaneously across three different panels. 

The Santa Fe Springs, California-based IVD firm said that it plans to add two new research-use-only panels to its test portfolio in 2023 and at least two more in 2024. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.