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In Brief This Week: FDA, Biodesix, DermTech, Chembio Diagnostics, More

NEW YORK – The US Food and Drug Administration this week revised the authorized uses and required updates to its list of SARS-COV-2 antigen tests that have received Emergency Use Authorizations. The revision requires test developers to make changes related to product labeling regarding repeat or serial testing. For a test that was previously authorized for testing of symptomatic individuals, that test is now authorized for use at least twice over three days with a minimum of 48 hours between tests. If a test was previously authorized for asymptomatic individuals, that test is now authorized for use at least three times over five days with at least 48 hours between tests. The revisions were made based on data that show repeating testing using COVID-19 antigen tests after a negative result increases the chance of an accurate result in people with and without symptoms. 

Biodesix said this week that its total revenues grew 71 percent to $11.1 million for the third quarter from $6.5 million a year ago. The firm's core lung revenues grew to $9.2 million from $4.5 million in Q3 2021, and COVID-19 revenues were up to $1.3 million from $506,000, while biopharma service revenues slipped to $664,000 from $1.5 million. Biodesix had a net loss of $13.7 million, or $.34 per share, for the recently completed quarter compared to a net loss of $11.5 million, or $.41 per share, a year ago. It finished the three months ended Sept. 30 with $15.2 million in cash and cash equivalents. For full-year 2022, the company said revenues are expected to be at the high end of its previous guidance of between $37.5 million and $39.5 million. 

DermTech this week reported third quarter revenues of $3.4 million, up 13 percent from $3.0 million in Q3 2021. The La Jolla, California-based dermatology genetic tests maker reported that its billable sample volume grew 54 percent year over year to 18,080. 

In a statement, DermTech CEO John Dobak lamented that despite the growth in billable sample volume, "sequential growth was flat due to headwinds caused by limited commercial payer coverage." 

Its net loss for the quarter climbed to $28.8 million, or $.96 per share, from $20.1 million, or $.68 per share. The higher loss was partly due to increased expenses with R&D costs rising to $5.7 million from $4.4 million year over year, and SG&A expenses jumping to $23.4 million from $16.0 million. 

DermTech finished the quarter with cash and cash equivalents of $95.5 million and short-term marketable securities of $53.6 million. 

Chembio Diagnostics reported this week that its revenues for the third quarter ending Sept. 30 declined 7 percent year over year to $11.2 million from $12.1 million the prior year quarter. The company's product revenue grew 16 percent, to about $10.8 million from $9.4 million a year earlier, and the company also saw gains in its R&D and license and royalty revenues. The company also cut its research and development spending by nearly half, to $1.9 million from $3.4 million. But it had no government grant revenue during Q3 2022, down from $2.4 million in Q3 2021. Chembio recorded a Q3 net loss of $6.7 million, or $.21 per share, up slightly from a net loss of $6.4 million, or $.24 per share, a year ago. The firm had $21.1 million in cash and cash equivalents as of Sept. 30. 

Sense Biodetection announced this week that it has entered into a strategic agreement with medical distributor Biotecom for nonexclusive distribution of Sense’s Veros COVID-19 testing platform in Chile. The point-of-care test uses a proprietary rapid amplification technology to return results in 15 minutes without an instrument. The agreement marks Sense’s entry into the South American market, the firm said in a statement. Sense has recently signed distribution deals for the test in Australia, New Zealand, and Europe. 

Yourgene’s first-half 2023 revenues declined 45 percent year over year to £9.6 million ($10.75 million). The firm this week said the decline was a result of a transition away from COVID services post-pandemic. Excluding COVID-related activities, its revenues were up 14 percent year over year at £8 million versus £7 million for the first half of 2022. The Manchester, UK-based firm noted that its Genomic Technologies business brought in revenues of £6.1 million for the six months ended Sept. 30, up 10 percent from revenues of £5.5 million. Within that segment, its noninvasive prenatal testing (NIPT) revenue was up 18 percent year over year. Yourgene also reported Genomic Services revenue growth of 26 percent to £1.9 million with NIPT services up 50 percent year over year. 

Trinity Biotech said this week that its revenues for the second quarter ended June 30 declined 29 percent year over year to $18.5 million from $25.8 million a year ago. Excluding a $7.4 million decline in the firm's COVID-19-focused PCR Viral Transport Media products, Q2 revenues were flat year over year. The company posted a net loss of $9.7 million, or $.29 per share, compared to a net loss of $783,000, or $.04 per share, a year ago. Trinity Biotech ended the quarter with $10.5 million in cash and cash equivalents. The firm said its revenue guidance for the full year is between $19 million and $20 million, with a predicted 30 percent increase in HIV point-of-care revenue and a 25 percent rise in revenue from its life sciences supply business, Fitzgerald Industries. The company also reduced its average number of employees in the first half of fiscal 2022 to 410 from 500 the prior year half and expects to further reduce that to fewer than 400 employees, and the firm is seeking US Food and Drug Administration 510(k) approval for its Premier Resolution Haemoglobin Variants instrument, which could be launched by Q2 2023. 

Talis Biomedical this week reported that its Q3 2022 revenues more than tripled to $796,000 from $218,000 in the prior-year quarter. Product revenue rose to $730,000 in the quarter after not recording any in Q3 2021, driven by antigen testing sales, and grant revenue declined to $66,000 from $218,000. Net loss was $26.0 million during the quarter, compared to $38.4 million in the third quarter of 2021. The company had $148.3 million in unrestricted cash and cash equivalents as of Sept. 30. During the quarter, Talis announced it would be cutting its workforce by 35 percent and stopping commercialization efforts for its standalone COVID-19 test to refocus on women’s and sexual health. 

AnPac Bio-Medical Science announced this week that its request for continued listing on the Nasdaq was granted by the Nasdaq Hearings Panel. The company must demonstrate compliance with the minimum bid price requirement of $1 by Nov. 23 to stay listed on the Nasdaq and must be able to demonstrate compliance with all requirements for continued listing, AnPac said in a statement. If it’s unable to maintain compliance, the firm’s securities may be delisted. Last month, the company presented its plan to regain compliance with the minimum bid price, which includes a share reverse split. The firm was notified by Nasdaq in September that its stock would be delisted. 

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.