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In Brief This Week: Roche, Veracyte, Hologic, Danaher, Chembio Diagnostics, Natera, and More

NEW YORK – Roche announced this week that it has completed its share purchase agreement to acquire 100 percent of the outstanding shares of TIB Molbiol Group. TIB Molbiol will operate as a subsidiary under Roche's diagnostics division and will expand the company’s molecular diagnostic solutions, particularly for Roche’s LightCycler PCR and MagNA Pure sample prep systems, Roche said, adding that TIB Molbiol already has more than 45 CE-marked tests available on the two systems.

Veracyte said this week that the Swedish Medical Technologies Product Council has recommended its Prosigna breast cancer assay for immediate reimbursement and clinical use in all Swedish healthcare regions without legal restrictions beginning Nov. 22. In addition to Sweden, Prosigna also saw a recent reimbursement approval in Germany. The assay is also endorsed by the UK's NICE diagnostics guidance and reimbursed in Spain, Denmark, Switzerland, and Israel.

This milestone supports Veracyte’s approach of offering its genomic tests in Europe and other countries on the nCounter Analysis System, which enables laboratories to run them for physicians and their patients locally, the company said, adding that this strategy aligns well with the European regulatory environment and can provide clinical information more effectively and efficiently.

PathoQuest said this week that it has obtained a Good Manufacturing Practices certificate for its quality control testing activities at its facility in Paris following a recent inspection by the French National Agency for the Safety of Medicine and Health Products. PathoQuest is offering sequencing-based testing services to assess the quality of human medicinal products and human investigational medicinal products at the French facility.

Chembio Diagnostics said this week that the South Africa Health Products Regulatory Authority has granted approval for its DPP SARS-CoV-2 Antigen test, enabling marketing and distribution of the assay in the country for use at the point of care by professional healthcare providers. The DPP SARS-CoV-2 Antigen test detects viral antigens in 20 minutes using a nasal swab and can be read visually or with the firm's DPP Micro Reader 2 optical analyzer, Chembio said.

The antigen test and the firm's DPP SARS-CoV-2 IgM/IgG Antibody test are authorized for import and distribution in South Africa by Chembio's distributor Patient Focus Africa.

Hologic said this week it has completed its previously announced acquisition of Louisville, Colorado-based Bolder Surgical. The transaction adds laparoscopic vessel sealing, dividing, and dissecting devices to the Hologic surgical portfolio and will enable it to expand the use of Bolder's devices to OB/GYN specialists.

OpGen said this week that its subsidiary Ares Genetics has licensed part of its proprietary ARESdb database of antimicrobial resistance genetic markers to an unnamed microbiology and infectious disease diagnostics company. Under the terms of the deal, the partner is gaining unrestricted and nonexclusive access to a small subset of the database, including genotype and AMR phenotype data, for a narrowly defined, undisclosed group of pathogens implicated in a type of treatment-resistant infections. Ares Genetics will receive an undisclosed on-time fee for data generation, data transfer, and data access.

Danaher said this week it plans to redeem all €800 million ($900 million) aggregate principal amount of 2.5 percent senior notes due in 2025. The notes were issued by DH Europe Finance and guaranteed by Danaher at a redemption price equal to the outstanding principal amount and a make-whole premium specified in the notes' indenture, plus accrued and unpaid interest. The redemption date is Dec. 29.

In a class action suit filed against Natera in the US District Court of the Northern District of California, the plaintiff filed a motion this week declining to proceed with the case before a magistrate judge. The clerk of the court reassigned the case to a district judge through a random drawing.

Todos Medical announced this week it has signed a binding agreement to acquire all 3CL protease biology-related assets from NLC Pharma and to form a majority-owned subsidiary called 3CL Sciences. The new business will develop diagnostics, therapeutics, and dietary supplements based on the assets. Todos will own 60 percent of 3CL Sciences with NLC Pharma shareholders owning the remaining 40 percent. Todos will provide $2.2 million in initial funding to 3CL and pay $2 million in cash over 15 months, as well as 13,333,000 ordinary shares of Todos' stock and single digit net royalties on 3CL protease-biology-related product sales to NLC Pharma. Todos also will support efforts to bring 3CL Sciences public within nine months of the closing of the deal, which is expected to be on Dec. 15.

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.