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In Brief This Week: Babson Diagnostics, HTG Molecular Diagnostics, Angle, Mainz Biomed, and More

NEW YORK – Babson Diagnostics said this week that its Austin, Texas-based laboratory has received accreditation from the College of American Pathologists as the result of a recent site inspection. The lab first received CAP accreditation in 2020. In its renewal application, the firm demonstrated proficiency for its proprietary blood testing techniques, which it said use significantly less sample volume than other technologies.

HTG Molecular Diagnostics said this week that it has entered into an agreement to sell securities in a private placement with an undisclosed healthcare investor and expects to obtain gross proceeds of approximately $7.5 million. The company intends to use the net proceeds for working capital and general corporate purposes. Under the agreement, HTG will issue 3,244,987 units at $2.312 per unit minus $0.001 for each pre-funded warrant purchased in lieu of a share of common stock. Each unit consists of one share of common stock or one pre-funded warrant, a common warrant to purchase one share of HTG's common stock with a term of 24 months from the issuance date, and a common warrant to purchase one share of its common stock with a term of 66 months from the issuance date. Cantor Fitzgerald is serving as the agent for the placement, which is expected to close around March 21.

Liquid biopsy firm Angle said this week that the Centers for Medicare and Medicaid Services has issued a certificate of registration under CLIA regulation to the firm's US clinical lab. After CMS audits the lab, which includes an inspection of the facilities and documentation on the validation of the assay to be performed, as well as quality control processes, a certificate of compliance may be issued. Upon completion of the accreditation process, Angle will be allowed to process patient testing samples for most of the US, though a handful of states require their own regulatory approval. Angle noted that accreditation of its UK laboratory is also progressing.

Digital pathology firms PathPresenter and 4D Path said this week that they have partnered to globally distribute 4D Path’s research-use-only 4D Q-plasia OncoReader Breast technology within PathPresenter’s ClinPx clinical workflow platform. Under the agreement, users will be able to run the 4D Path technology within the ClinPx whole-slide image viewer. The 4D Path technology is intended to help histopathologists improve diagnostic accuracy of breast cancer features solely from digitized images obtained through biopsies or resections, the companies said in a statement. Integrating the two technologies will potentially improve the throughput, reliability, and quality of consultations provided by physicians, the firms added.

Mainz Biomed said this week that it has partnered with Sentinel Diagnostics and Alcedis to support the firm's ColoFuture clinical study to evaluate integrating mRNA biomarkers into its ColoAlert colorectal cancer test. Under the agreement, Alcedis will provide clinical trial management and Mainz Biomed will have access to the Sentifit 270 Analyzer, Sentinel's automated Fecal Immunochemical Test (FIT) processing system. The study's main goal is to determine ColoAlert's sensitivity and specificity for colorectal cancer with the new mRNA biomarkers. Secondary endpoints include sensitivity for advanced adenoma lesions in colon, specificity for advanced precancerous lesions in colon, and specificity for normal colon findings.

Strata Oncology this week enrolled the first patient in the Strata Sentinel trial evaluating its StrataMRD circulating tumor DNA test to detect tumor recurrence and monitor treatment effectiveness. The observational study aims to enroll 100,000 patients with early-stage solid tumors who have undergone surgery or other therapy with curative intent to validate the ability of the StrataMRD test to detect cancer recurrence and monitor the clinical benefit of adjuvant or other treatments. The first patient was enrolled at Ochsner Cancer Institute in Louisiana, and Strata plans to enroll patients across 25 sites in the US.

Swedish medical imaging IT company Sectra said this week that it has signed a digital pathology contract with Erasmus University Medical Center. Sectra’s digital pathology technology will be integrated into Erasmus’ IT infrastructure, including its laboratory information system, and will provide pathologists with an overview of a patient’s history in one application, Sectra said in a statement. Financial and other terms of the deal were not disclosed.

Centogene said this week that it has expanded its data access and collaboration agreement with Pfizer. The initial agreement, signed in 2019, granted Pfizer access to data from Centogene's bio/databank for the discovery and validation of genetic and biochemical targets for the development of rare disease therapies. The firms have now initiated a new collaborative research project that will use an existing cohort of patient samples from Centogene's bio/databank to validate rare genetic causes of neurodegenerative diseases as potential drug targets.

German sample prep firm BioEcho Life Sciences said this week that it has received ISO 13485 and ISO 9001 quality management certifications. The certifications "now give us the opportunity to expand into new markets like the biopharmaceutical industry and enable more companies and institutions to reduce their environmental footprint," BioEcho Founder and Managing Director Markus Müller said in a statement.

Todos Medical said this week that it has completed its previously announced acquisition of all 3CL protease biology-related assets from NLC Pharma and the formation of 3CL Pharma, a majority-owned subsidiary. The assets include TolloTest, a diagnostic testing platform to detect the presence of the 3CL protease of SARS-CoV-2. 3CL Pharma will develop diagnostics, therapeutics, and dietary supplements based on 3CL protease biology-related work of Dorit Arad, who is joining Todos as CSO and will also serve as chief technology officer of 3CL Pharma.

Australian infectious disease diagnostics firm Genetic Signatures said this week that it has opened a laboratory at BioHub Birmingham in the UK as part of its planned expansion to Europe, the Middle East, and Africa. The new BioHub laboratory will develop protocols, processes, and quality performance materials needed for the expansion and will offer customers training and technical support for the company's diagnostic kits and automated platforms.

Tesis Biosciences said this week that it will be the exclusive provider of pharmacogenomic services for Frontier Management, which operates 130 independent living, assisted living, and memory care facilities in the US. As part of the agreement, Tesis will conduct a study with Frontier Management on how pharmacogenomic testing might be able to help prevent falls in older adults by adjusting their medication correctly.

Co-Diagnostics said this week that its board of directors has authorized a share repurchase program to repurchase up to $30 million worth of the company’s common stock.

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.