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

NEW YORK – 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.

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.

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.

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.

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 45 CE-marked tests available on the two systems.

Dutch genome annotation company Annogen said this week that is has entered into a research collaboration with an undisclosed pharmaceutical company. Under the terms of the agreement, Annogen will use its proprietary SuRE technology to functionally annotate noncoding genome sequences in order to identify disease-relevant regulatory elements and variants.

Tempus said this week that it is expanding an existing strategic collaboration with Janssen Research & Development to include artificial intelligence-based work to aid in the discovery and development of oncology treatments.

Labcorp and ConcertAI this week announced a collaboration to optimize precision oncology clinical trials. The partnership aims to launch cancer trials that minimize the burden on physicians, improve patient recruitment and retention, and ensure equitable access to research. Labcorp will use ConcertAI's artificial intelligence and real-world data platforms to design more effective and more inclusive trials.

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.

Hologic said this week it has completed its previously announced acquisition of Louisville, Colorado-based Bolder Surgical, which provides energy vessel sealing surgical devices. 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, the firm said.

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.

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.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb. 

The Scan

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The approach helps overcome limitations of previous studies that had investigated the molecular mechanisms of pancreatic islet beta cells, the authors write in their Nature Genetics paper.

Culture-Based Methods, Shotgun Sequencing Reveal Transmission of Bifidobacterium Strains From Mothers to Infants

In a Nature Communications study, culture-based approaches along with shotgun sequencing give a better picture of the microbial strains transmitted from mothers to infants.

Microbial Communities Can Help Trees Adapt to Changing Climates

Tree seedlings that were inoculated with microbes from dry, warm, or cold sites could better survive drought, heat, and cold stress, according to a study in Science.

A Combination of Genetics and Environment Causes Cleft Lip

In a study published in Nature Communications, researchers investigate what combination of genetic and environmental factors come into play to cause cleft lip/palate.