Alercell Inc., of Bozeman, Mont., said it will begin distributing its Clip COVID rapid antigen test across the U.S. through its networks and partnerships. The tests received FDA emergency use authorization in December for point-of-care use in CLIA laboratories, including CLIA-waived laboratories.
Denver-based Assure Holdings Corp. has inked an agreement with Aetna Colorado allowing the company to provide its neuromonitoring services as an in-network health care provider for the insurer in Colorado.
Boulder, Colo.-based Biodesix Inc. said it plans to add a blood-based 52-gene next-generation sequencing test to its portfolio of molecular testing, based on a recent publication in Diagnostics. The study showed that the liquid biopsy test was able to detect actionable genomic alternations in patients with non-small-cell lung cancer with a turnaround time of 72 hours.
Singapore-based Genesis Medtech Group has entered an agreement with Livsmed Inc., of Seongnam, South Korea, for the sale and distribution of Livsmed’s Artisential line of products in China and Singapore.
Singapore-based Health Management International Ltd. (HMI Group) and Siemens Healthineers AG, of Erlangen, Germany, have forged a five-year partnership to advance health care delivery in Southeast Asia. As part of the collaboration, HMI Group will invest more than SGD32 million (US$24.1 million) to roll out medical technologies and digital platforms, enhance clinical education and further develop centers of excellence in cancer, neuroscience and cardiovascular disease.
San Diego-based Illumina Inc. said it will donate $60 million in sequencing capabilities to a global pathogen genomics initiative, in partnership with the Bill & Melinda Gates Foundation and other public and private entities. The initiative expands on the Africa Pathogen Genomics Initiative announced in October, and will help create a comprehensive pathogen genomic network around the world, building critical public health capabilities in areas of need.
Inivata Ltd., of Cambridge, U.K., has entered an agreement with Agendia Inc., of Irvine, Calif., giving the latter co-exclusive rights to distribute Inivata’s Radar liquid biopsy assay for the detection of minimal residual disease and early detection of relapse in patients with breast cancer in North America and Europe. The agreement includes an option to extend to other territories over time. It is expected that the Radar assay will be reimbursed and available in the U.S. during 2022. Financial and commercial terms were not disclosed.
Isohelix Ltd., of Kent, U.K., and Holliston, Mass.-based Autogen Inc. reported a far-reaching supply agreement. The agreement follows the successful validation of the Isohelix Genefix range of saliva collection products on the Autogen Flexstar and Flexstar+ DNA extraction workflows.
Lewisville, Texas-based Orthofix Medical Inc. said it has entered an exclusive license agreement to commercialize the portfolio of Campania, Italy-based Igea SpA’s bone, cartilage and soft tissue stimulation products in the U.S. and Canada. Under the terms of the agreement, Orthofix has the rights to pursue FDA approvals and commercialization of Igea’s platform of orthopedic products, which are not currently available in the U.S.
Shockwave Medical Inc., a Santa Clara, Calif.-based developer of intravascular lithotripsy (IVL) technology to treat severely calcified cardiovascular disease, reported that CMS published the Fiscal Year 2022 Hospital Inpatient Prospective Payment System Proposed Rule, which recommended that coronary IVL cases be eligible for incremental payment via a new technology add-on payment from CMS when performed in the hospital inpatient setting. The proposed annual rule is now open for public comment and is expected to be finalized and in effect by Oct. 1, 2021.
Tridiuum Inc., a Philadelphia-based provider of digital behavioral health solutions, and Nocd Inc., a Chicago-based provider for the treatment of obsessive-compulsive disorder (OCD), reported a partnership to support individuals with OCD. The companies will focus on identifying more patients with OCD to diagnose them correctly faster and with less effort. The integrated approach will guide patients to Nocd's therapy.
Xphyto Therapeutics Corp., of Vancouver, British Columbia, said it has delivered 2,000 of its Covid-ID Lab rapid PCR tests to a medical distributor in Israel for clinical evaluation in order to obtain commercial regulatory approval.