NEW YORK – Biocept said this week that it received a notice from the Nasdaq Listing Qualifications Department advising it that it was not in compliance with the exchange's continued listing requirements as a result of its failure to file its quarterly Form 10-Q for the quarter ended June 30, 2022, in a timely manner. On Aug. 16, 2022, Biocept disclosed in an SEC filing that it was unable to file Form 10-Q within the prescribed time period as a result of an ongoing accounting review, including the analysis of previously reported material weaknesses and matters related to the US Health Resources Services Administration and its funding for reimbursement of COVID-19 testing services performed by Biocept.
Under Nasdaq rules, Biocept has 60 calendar days from the receipt of the notice, or until Oct. 17, 2022, to submit a plan to regain compliance with the rule. If Nasdaq accepts Biocept's plan, it may grant Biocept up to 180 calendar days from the due date of Form 10-Q, or until Feb. 13, 2023, to regain compliance.
The US Food and Drug Administration this week granted breakthrough device designation to BioMérieux’s Specific Reveal Rapid Antimicrobial Susceptibility Test (AST) System. BioMérieux announced the acquisition of the technology along with its developer, Specific Diagnostics, in April.
Genetron Cofounder, Chairman, and CEO Sizhen Wang has submitted a preliminary nonbinding proposal letter to acquire all of the company's outstanding ordinary shares, the China-based precision oncology firm said this week. Wang's proposal dated Aug. 21 also includes American depositary shares of Genetron, each representing five ordinary shares. The bid suggests Wang intends to fund the transaction with a combination of debt and equity capital. In a filing with the US Securities and Exchange Commission, Genetron said that equity financing for the transaction is expected to be provided in the form of rollover equity in the company and cash contributions from both Wang and third-party sponsors. The firm's board has formed a special committee comprising two independent directors to evaluate the proposed transaction "as well as other potential strategic alternatives," Genetron said.
Biocartis announced this week that it has obtained ISO 27001 certification for the design, development, maintenance, service provision, and support of the Idylla platform and associated customer-facing software.
Todos Medical this week said that its second quarter revenues grew 29 percent year over year to $2.2 million from $1.7 million a year ago. The company had a net loss of $6.8 million, or $.01 per share, for the three months ended June 30 compared to a profit of $3.4 million, or $.01 per share, a year ago. Its R&D costs dropped to $13,000 in Q2 2022 from $239,000 a year ago, while its SG&A costs grew 45 percent to $3.2 million from $2.2 million. Todos exited Q2 with $17,000 in cash and cash equivalents.
MDxHealth said this week that its revenues for the first half of 2022 increased 21 percent to $13.0 million from $10.7 million a year ago. The firm added that revenues for the second quarter, ended June 30, grew 22 percent year over year to $6.9 million. MDxHealth had a net loss of $18.1 million, or $.12 per share, for the first half of 2022 compared to a net loss of $13.3 million, or $.12 per share, during the year-ago period. The company had $40.0 million in cash and cash equivalents as of June 30. For full-year 2022, it is guiding to revenues of between $27 million and $29 million for the company's existing business. Adding revenues from the Oncotype DX GPS business acquired from Exact Sciences earlier this month, MDxHealth's total revenues for the year are anticipated to be between $40 million and $42 million.
Nanomix announced this week a distribution agreement with BioAsia to distribute the Nanōmix eLab system in Singapore and Brunei. The deal includes the Nanōmix S1 Panel assay and future new test products for the eLab system. Financial and other terms were not disclosed. The Nanōmix eLab system is a handheld, mobile immunoassay and chemistry diagnostic system that provides results in minutes, lower cost, and portability, the company said. BioAsia is a medical diagnostics distributor based in Singapore.
Devyser Diagnostics said this week that its preliminary second quarter revenues rose 42 percent to SEK 30.9 million ($2.9 million) from SEK 21.8 million a year ago. The Swedish firm said that the after-tax loss for the recently completed quarter was SEK 14.3 million, or SEK .90 per share, compared to an after-tax loss of SEK 6.2 million, or SEK .55 per share, a year ago. Devyser had SEK 400.8 million in cash and cash equivalents as of June 30.
Immunovia said this week that its net sales for the second quarter rose 171 percent to SEK 103,000 ($9,680) from SEK 38,000 a year ago. The Swedish developer of blood-based diagnostics reported a net loss of SEK 33.7 million, or SEK 1.49 per share, for the three months ended June 30 compared to a net loss of SEK 49.3 million, or SEK 2.18 per share, a year ago. Immunovia had SEK 197 million in cash and cash equivalents at the end of Q2 2022.
Quotient Limited announced this week the Sanquin Blood Supply Foundation's National Screening Laboratory has joined the MosaiQ Innovator's Circle, made up of lab experts focused on transfusion medicine and other issues in clinical diagnostics. Sanquin, the Netherlands' nonprofit central blood bank, will work with Swiss firm Quotient to improve clinical practices and patient care, the company said. MosaiQ is Quotient's microarray testing platform.
C2N Diagnostics and Eisai have entered into a memorandum of understanding to build awareness about the role of blood-based assays in diagnosing and guiding treatment for cognitive impairment, including Alzheimer's disease, particularly in underserved communities. As part of the agreement, the companies said they will work to build awareness and develop real-world evidence to support the use of blood-based assays in people living with cognitive impairment who are not currently participating in a clinical trial.
Privately held medical device company Satio said this week that it has formed a strategic partnership with Senegal's Institut Pasteur de Dakar to combine Satio's intradermal patches with various technologies from the institute to accelerate the clinical development of vaccine patches and diagnostic patches for blood sampling, genetic testing, and pathogen surveillance. Satio's technologies are designed to "transform the workflows in healthcare for blood draw, diagnostics, and drug delivery using our patented patch-based technology," Namal Nawana, executive chairman and founder of Satio, said in a statement. The Boston-based company has three platforms in development: a vaccine and drug-delivery patch that allows for intradermal delivery; dry blood spot and whole-blood sampling patches for lab-based and genomic testing; and a consumer-based diagnostic patch.
Telehealth firm LifeMD said this week that its wholly owned subsidiary Cleared is partnering with Allergenis to offer that firm's peanut allergy diagnostic blood test. Cleared will be the exclusive telehealth provider for the commercial launch of the test. The laboratory-developed test provides patients their reactivity level to peanuts and is validated for individuals ages 4 and above.
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.