Phoenix-based Accumen Inc. has partnered with Spectrum Solutions Inc., of Madison, Ala., to provide COVID-19 saliva testing kits nationally. The U.S. FDA authorized saliva collection using Spectrum’s SDNA-1000 saliva collection device in April, based on a trial with Rutgers University. Accumen is offering full kit or saliva collection device-only orders.
Alercell, of Bozeman, Mont., reached an agreement for the distribution of COVID-19 rapid antibody serology tests with manufacturer Medigen Biotechnology Corp., of Taipei, Taiwan.
Brain Navi Biotechnology Co. Ltd., of Zhubei, Taiwan, has developed a robot to perform nasal swab tests to prevent cross infections. The company is in the process of obtaining U.S. FDA emergency use authorization and Taiwan FDA approvals for the device.
Cytosorbents Corp., of Monmouth Junction, N.J., said that the assistant secretary of defense for health affairs has awarded the company a three-year contract valued at up to $4,421,487 as part of a Peer Reviewed Medical Research Program Technology/Therapeutic Development Award to complete preclinical development of the Hemodefend-BGA plasma and whole blood adsorber.
Electrocore Inc., of Basking Ridge, N.J., reported more information about the Gammacore Sapphire CV noninvasive vagus nerve stimulation therapy under its emergency use authorization (EUA). The EUA allows for the use of at home or in a health care setting to acutely treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief. Initial distribution to hospitals and patients was slated to begin July 31.
Fluidigm Corp., of South San Francisco, said it is among the first seven companies selected to advance the National Institute of Biomedical Imaging and Bioengineering’s Rapid Acceleration of Diagnostics program, which aims to fast track development and commercialization of novel technologies to boost U.S. testing capacity for SARS-CoV-2. A letter contract provides Fluidigm with up to $12 million of initial funding based on completion and delivery of certain milestones related to Fluidigm microfluidics technology and expansion of related manufacturing capacity.
Guardant Health Inc., of Redwood City, Calif., reported a strategic collaboration with Waltham, Mass.-based Radius Health Inc. to pursue regulatory approval of the Guardant360 CDx as a companion diagnostic for elacestrant (RAD1901), an investigational selective estrogen receptor degrader being studied in the treatment of advanced ER-positive, HER2-negative breast cancer resistant to CDK4/6 inhibitors in combination with hormone therapy.
Mammoth Biosciences Inc., of South San Francisco, has received a contract from the NIH as part of its $1.5 billion Rapid Acceleration of Diagnostics program, making it the first CRISPR-based initiative to be funded by the program. The company will use the award to scale its Detectr test onto high-throughput platforms in commercial labs for COVID-19 diagnostics at an accelerated rate.
Salt lake City-based Myriad Genetics Inc. said CMS has expanded Medicare coverage for its Bracanalysis CDx to include men with prostate cancer who are eligible or may become eligible for treatment with Lynparza (olaparib).
San Francisco-based data analytics company Phylagen Inc. has launched its Phylagen Surface SARS-CoV-2 (COVID-19) test kit for surface testing in shared spaces such as nursing homes, schools and offices.
San Diego-based Quidel Corp. said it has entered a preliminary letter contract with the National Institutes of Health, through its newly launched Rapid Acceleration of Diagnostics – Advanced Technology Platforms initiative, to support the expansion of its diagnostic assays that test for SARS-CoV-2 antigen using its Sofia Fluorescence Immunoassay platform. The preliminary contract is expected to lead to a definitive agreement for $71 million to support the initiative by mid-September.
Amsterdam-based Royal Philips NV said it has received the report from the U.S. House of Representatives Subcommittee on Economic and Consumer Policy on the COVID-19 pandemic and is providing an initial response. In April, the company received a letter from the subcommittee seeking information about its hospital ventilator activities in connection with contracts for the delivery of 10,000 Trilogy Universal ventilators and 43,000 Ev300 ventilators to the U.S. Department of Health and Human Services. Philips said it has cooperated with the subcommittee’s requests.
St. Louis-based Stereotaxis Inc. and Acutus Medical Inc., of Carlsbad, Calif., reported the first integrated cardiac ablation procedure benefiting from remote telerobotic support. The procedure was performed at Baptist Health in Lexington, Ky., using Stereotaxis’ Robotic Magnetic Navigation and Acutus’ Acqmap systems supported by technical and clinical experts from each company using proprietary connectivity technology.