NEW YORK – Biodesix said this week that its laboratory in DeSoto, Kansas, has been accredited by the College of American Pathologists and has received ISO 13485:2016 certification. CAP accreditation followed an inspection by the college’s inspectors, while the British Standards Institute awarded the firm ISO certification on behalf of the International Organization for Standardization.
Avisa Diagnostics said this week that it has closed a non-brokered private placement that was announced last week. The company issued 632,000 common shares at a price of C$.20 ($.16), raising a total of C$126,400. It was made to an eligible purchaser resident in the US. Avisa said it would use the funding for operations and to expand its business, as well as for general capital purchases.
French testing certification firm GMED said recently that it has been designated a notified body, effective Aug. 20, making it the sixth firm to receive such designation under the EU's In Vitro Diagnostic Regulation. The new regulatory framework for IVDs in Europe is scheduled to take effect in May 2022, though there are calls to postpone its implementation. Notified bodies assess IVDs to ensure they comply with the new regulations.
OrigiMed said last week that its Human NTRK1/2/3 Genomic Alteration Testing Kit was granted a special review procedure for innovative medical devices by China's National Medical Products Administration. The test is being developed in China as a companion diagnostic for Bayer's TRK inhibitor larotrectinib (Vitrakvi) to identify NTRK gene fusion-positive patients. Bayer submitted larotrectinib for marketing authorization in China in May.
New York City-based Mount Sinai Health System said this week that it has received a $60 million gift from James S. and Merryl Tisch, which it will put toward establishing the Mount Sinai Tisch Cancer Center. The center, which will include the Tisch Cancer Hospital, the Tisch Cancer Institute at Icahn Mount Sinai, several cancer centers of excellence, and an ambulatory cancer network, is designed to improve access to breakthrough therapies, diagnostics, and clinical trials, and will help Mount Sinai achieve its mission of providing personalized cancer treatment to patients from all communities and backgrounds.
Sophia Genetics and Brazilian molecular diagnostics firm Dasa said this week that they have expanded an existing partnership to create a decentralized homologous recombination deficiency analytics system. The firms have been working together since 2016.
Wiltshire, UK-based Presymptom Health said this week it has closed a seed round of financing to support the development of a blood test for the early detection of sepsis. The company said the funding from Ploughshare Innovations and UK Innovation & Science Seed Fund will enable it to complete clinical trials at several hospitals in the UK and advance its test toward registration and launch. This latest round of funding takes Presymptom to almost £1 million ($1.4 million) raised since early 2020, the firm said. On its website, Presymptom noted that it intends to offer molecular central laboratory tests and a protein-based point-of-care test for sepsis.
Caris Life Science said this week that the O'Neal Comprehensive Cancer Center at the University of Alabama at Birmingham has joined the Caris Precision Oncology Alliance. The alliance is a network of 52 cancer centers that conduct research on predictive and prognostic biomarkers to advance comprehensive cancer profiling and establish standards of care for molecular testing. The O'Neal Comprehensive Cancer Center will gain access to Caris' database and artificial intelligence platform and can participate in biomarker directed trials sponsored by the pharmaceutical industry.
Personalis said this week that it plans to relocate both its corporate headquarters and clinical laboratory from its current location in Menlo Park, California, to a 100,000-square-foot facility at 6600 Dumbarton Circle in Fremont, California. The new facility will support the company's future growth plans and provide greater capacity for laboratory operations and R&D activities. The relocation is expected to occur within the next 12 months and the firm has signed a 13-year lease.
CellMax Life said this week that its FirstSight colorectal precancer and cancer detection blood test has received Breakthrough Device Designation from the US Food and Drug Administration. The test is based on both circulating cancer cell detection and analysis of circulating tumor DNA, which are algorithmically combined with age and gender to give a readout on whether a patient is at low or high risk of developing a colorectal tumor or at high risk for precancer.
The firm said it is currently conducting a multicenter US study to further optimize its test, prior to initiating a pivotal study to support FDA approval.
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.