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In Brief This Week: Bio-Techne, Mologic, Caris Life Sciences, And More

NEW YORK – Bedfordshire, UK-based Mologic said this week that its rapid antigen test for COVID-19 has been selected for the second phase of the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) initiative, involving the manufacturing scale-up of the company's tests. 

Mologic is developing a nasal swab test that detects the SARS-CoV-2 nucleoprotein in about 20 minutes. A person without medical training can run the test at the point-of-need, including in the home, workplace, education settings, and travel settings.  

The company said that it is accelerating the development and clinical validation of the test and receiving guidance about its Emergency Use Authorization from the US Food and Drug Administration. 

Bio-Techne this week announced it has completed the previously announced acquisition of Asuragen for $215 million in cash and up to $105 million upon the achievement of future milestones. 

The Asuragen acquisition added a portfolio of molecular diagnostic tests and research products, including genetic screening kits, oncology testing kits, and molecular controls, Bio-Techne said. Asuragen also has a 50,000-square-foot manufacturing facility, a CLIA-certified laboratory, and expertise in bringing diagnostic tests to market through regulatory processes. 

Caris Life Sciences said this week that the Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale” (Pascale Foundation) in Italy has joined its Precision Oncology Alliance, a collaborative network of leading cancer centers working to advance comprehensive cancer profiling and establish standards of care for molecular testing and personalized treatment strategies in oncology. 

The largest clinical care and research cancer center in southern Italy, Pascale Foundation joins nearly 50 other institutions in the Caris POA. Membership confers increased access to the Caris' database and artificial intelligence platform for clinical use in patient care and for studies aimed at establishing new evidence-based standards. POA members are also able to integrate with a growing portfolio of biopharma-sponsored biomarker directed trials. 

The Barbara Ann Karmanos Cancer Institute in Detroit this week announced a partnership with The Toledo Clinic to open a new cancer center in Maumee, Ohio in 2022. The two entities will jointly provide services that involve multidisciplinary clinics, diagnostic imaging, pharmacy, laboratory testing, genetic counseling, and social services. The aim within this new cancer center, which will have 22 exam rooms and 24 infusion bays, will be to expand patients' access to advanced care options and clinical trials, the partners said.  

The involvement of Karmanos, a National Cancer Institute-designated comprehensive cancer center, will increase patients’ access to investigational drugs through clinical trials and research protocols in northwest Ohio. The new cancer center will utilize telemedicine and auxiliary services, as well as virtual support groups and social services, to expand the reach of care teams into the community.

Dante Labs said this week that it has received ISO 13485:2016 certification from the British Standards Institution Group for its Immensa genomic interpretation software as a medical device. Validation involved using whole-genome sequencing data from 500,000 samples. Illumina instruments were used for the sequencing. The company already has CE-IVD marking for Immensa. 

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.