NEW YORK – In documents filed with the US Securities and Exchange Commission this week, OpGen disclosed that its subsidiary Curetis is in default of its contract with the European Investment Bank as it has failed to repay certain outstanding debts. Curetis currently owes the EIB approximately €9.7 million ($10.4 million) and interest will continue to accrue until all the amounts owed are paid in full, OpGen said. The EIB demanded that OpGen immediately pay all of the amounts owed, but OpGen said it is unable to repay the amount owed to the EIB. If it is unable to negotiate a resolution of the defaults and the EIB enforces payment through legal means, it could cause the company to file for bankruptcy protection, OpGen said.
The US National Institutes of Health said this week its Home Test to Treat program has expanded to provide national at-home COVID-19 testing, telehealth sessions, and antiviral treatment. The NIH, Administration for Strategic Preparedness and Response, and Centers for Disease Control and Prevention launched Home Test to Treat in January as a pilot program for up to 8,000 eligible patients and said at the time that program officials aimed to offer services to about 100,000 people in the US in the following year. With the expansion, the program now offers free testing, telehealth, and treatment for COVID-19 and flu A/B. The program provides Lucira by Pfizer COVID-19 & Flu Test.
Danaher this week said that its board of directors has approved a regular quarterly cash dividend of $.24 per share of its common stock, payable on Jan. 26 to shareholders of record on Dec. 29.
The company also announced this week that it has completed its previously announced acquisition of Abcam. Abcam was acquired for $24 per share in cash through a court-sanctioned scheme of arrangement that became effective Dec. 6. Abcam is now an indirect wholly owned subsidiary of Danaher.
Oncocyte said this week that it has begun the process of seeking US Food and Drug Administration approval for its laboratory developed VitaGraft transplant assays. The move comes after the company received a positive coverage decision in August from the Center for Medicare and Medicaid Services MolDx Program for its Kidney indication, which is expected to launch commercially in the first half of 2024.
Cardio Diagnostics said this week that it has regained compliance with Nasdaq's minimum bid price requirement for continued listing on the exchange. The Chicago-based company had been notified by Nasdaq on Sept. 21 that it was not in compliance because its common stock did not close at $1.00 or more for 30 consecutive business days. To regain compliance, the company's stock needed to have a minimum closing price bid of $1.00 or more for at least 10 consecutive business days. As a result, the matter is now closed.
Dutch startup MLA Diagnostics said last week that it has obtained an undisclosed amount of "seven-figure" funding for the further development of its DNA methylation assay on skin biopsies to discriminate between patients at high or low risk of skin cancer. The goal is to externally validate the assay, which looks for LY75 gene promoter methylation, in preparation for future clinical trials. The investment came from NLC Health Ventures, LIOF, and Brightlands Life Science Ventures. -
Biological Dynamics announced this week that it is expanding enrollment for its ExoLuminate study with the addition of four new institutions: the Dana-Farber Cancer Institute; Moores Cancer Center at UC San Diego Health; University of Florida Health; and MedStar Georgetown.
The study (NCT05625529) aims to validate the firm's ExoVita Pancreas assay for early cancer detection in individuals with high risk of pancreatic cancer based on genetic mutations, strong family history, the presence of cystic lesions in the pancreas, and pancreatitis. Biological Dynamics previously partnered with the PRECEDE Consortium to accelerate enrollment of at least 5,000 subjects.
Swedish diagnostics company Devyser announced this week that it has been awarded a tender with Wales Blood Services for its Devyser RHD test, a noninvasive qPCR-based assay to determine fetal RHD status in maternal plasma during pregnancy. The tender covers fetal RHD testing in Wales and is valid for three years with the possibility of a two-year extension. The order value is estimated to be about SEK 1 million ($96,379) per year, the company said in a statement.
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.