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In Brief This Week: Biocept, Quest, Agilent, MDxHealth, OpGen, More

NEW YORK – Biocept carried out a 1-for-30 reverse stock split, and its shares began trading on a split-adjusted basis on the Nasdaq on May 17. Shareholders of the company's stock authorized the stock split last week. The company also disclosed in a document filed with the US Securities and Exchange Commission this week that its stockholder equity as of March 31 was $2.4 million, short of the $2.5 million minimum in stockholder equity needed to remain listed on the Nasdaq Capital Market. As a result, Biocept said it anticipated being notified by the exchange on or about May 15 of its noncompliance. The company will have 45 calendar days after receipt of the notice to submit a plan to regain compliance, and if the plan is accepted, Nasdaq may grant it up to 180 calendar days from the day of the notice to provide evidence of compliance. 


Quest Diagnostics said this week that its board of directors has declared a quarterly cash dividend of $.71 per share payable on July 25 to shareholders of record of Quest common stock on July 11. 


Agilent Technologies said this week that its board of directors has approved a quarterly dividend of $.23 per share of common stock. The dividend is payable July 26 to all shareholders of record at the close of business July 3. 


Urology diagnostics firm MDxHealth reported this week that its first quarter revenues rose 141 percent year over year to $14.7 million from $6.1 million one year earlier. The firm reported $6.2 million of its Q1 revenues came from sales of its Genomic Prostate Score assay acquired from Exact Sciences last year. Excluding sales of that test, the firm's remaining Q1 revenues of $8.5 million were up 39 percent year over year. 

Among the firm's other products, billable test volume for the three months ended March 31 was 4,366 for the firm's Confirm MDx assay, up 5 percent, and 3,181 for the firm's Select MDx assay, down 4 percent compared to the year-ago quarter. 

The firm posted a net loss for the quarter of $11.7 million, or $.05 per share, compared to a net loss of $8.3 million, or $.05, in the year-ago quarter. The firm had $48.3 million in cash and cash equivalents as of March 31. 


Maxim Biomedical said this week that it signed a contract with the National Institutes of Health through the Rapid Acceleration of Diagnostics initiative to develop a multiplex COVID-19 and influenza A and B lateral flow assay to be used with the firm's battery-powered FiarFly analyzer. The Maryland-based company said its platform delivers laboratory-like sensitivity at a cost comparable to home-use rapid antigen tests. Maxim also received RADx funding toward development of its rapid SARS-CoV-2 test, the MaximBio ClearDetect COVID-19 Antigen Home Test, and the US Food and Drug Administration issued Emergency Use Authorization for that 15-minute over-the-counter test in January 2022. 


OpGen this week said it nearly doubled its first quarter revenues to $913,444 from $469,745 a year ago, primarily driven by collaboration revenue. In Q1, the Rockville, Maryland-based company submitted a de novo classification request to the US Food and Drug Administration for the marketing authorization of the Unyvero Urinary Tract Infection panel. If cleared, this panel would become the first-ever rapid multiplex sample-to-answer in vitro diagnostic for urinary tract infections in the US. OpGen trimmed its net loss to $5.7 million, or $1.25 per share, from a net loss of $6.8 million, or $2.93 per share, a year ago. The company used approximately 4.6 million shares to calculate per-share loss in the recently completed quarter compared to about 2.3 million shares in the year-ago period. OpGen finished Q1 with $7.0 million in cash and cash equivalents. OpGen said that it expects full-year 2023 revenues to be in the range of $4 million to $5 million. 


Lucid Diagnostics said this week that its revenues more than doubled to $446,000 for the first quarter from $189,000 a year ago. The New York City-based cancer diagnostics firm said that its CLIA-certified clinical laboratory performed 1,841 commercial EsoGuard Esophageal DNA Tests for the three months ended March 31, up 245 percent year over year. Lucid had a net loss of $16.2 million, or $.40 per share, compared to a net loss of $12.3 million, or $.35 per share, a year ago. Non-GAAP loss per share for the recently completed quarter was $.24. Its R&D costs decreased to $2.1 million from $2.8 million a year ago, while its SG&A costs grew to $7.5 million from $5.5 million. The company finished Q1 2023 with $39.5 million in cash and cash equivalents. 


Mainz Biomed reported $250,104 in revenues for the first quarter of 2023 this week, more than double the Q1 2022 revenues of $100,565. Almost all revenues came from its ColoAlert colon cancer screening test. The German molecular diagnostics firm booked a Q1 net loss of $6.6 million, or $.45 per share, up from a net loss of $5.7 million, or $.42 per share, in the year-ago quarter. Its R&D expenses rose almost fivefold year over year to $2.6 million from $563,572, while its SG&A costs fell 22 percent to $4.0 million from $5.1 million a year ago. The company ended the quarter with $10.9 million in cash, which it said it believes will last "past the end of 2023." 


Centogene said this week that its 2022 revenues totaled €47.5 million ($51.4 million), up 12 percent from €42.2 million in restated 2021 revenues, which don't include receipts from the firm's hence-discontinued COVID-19 testing business. Diagnostics revenues were up 18 percent year over year to €31.4 million, driven by clinical whole-exome and whole-genome sequencing, while pharmaceutical revenues increased 3 percent to €16.1 million, buoyed by collaborations with pharma partners in rare and neurodegenerative disorders. The German molecular diagnostics company said it expanded its bio-databank to more than 750,000 patients last year. Net loss for the year totaled €31.9 million, or €1.19 per share, compared to a net loss of €45.7 million, or €2.04 per share, in 2021. R&D expenses for 2022 totaled €17.5 million, down 9 percent from €19.3 million the year before, and SG&A costs were €42.5 million, down 20 percent from €52.8 million in 2021. Centogene ended the year with €36.0 million in cash and cash equivalents and stated that there is "uncertainty about the company's ability to continue as a going concern." For 2023, the Rostock-based company expects revenue growth between 10 and 15 percent. 


 Exagen this week reported that its Q1 2023 revenues rose 8 percent to $11.2 million compared to $10.4 million in Q1 2022. It delivered 37,312 Avise CTD tests during the quarter, up 21 percent year over year. Net loss in the quarter was $7.7 million, or $.44 per share, compared to $10.3 million, or $.60 per share, in the first quarter of 2022. The company ended the quarter with $52.2 million in cash and cash equivalents. Exagen also said it expects Q2 2023 revenues in the range of $10.7 million to $11.2 million. 


Liquid biopsy firm Cellsway and genetics lab Omega Genetik said this week that they have entered into a partnership and commercialization agreement to provide cancer management solutions to patients and healthcare professionals throughout Turkey. Under the agreement, Omega Genetik will use Cellsway's circulating tumor cell isolation technology to analyze tumor-associated gene expression for noninvasive monitoring and treatment personalization. Financial terms were not disclosed. 


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.