1Health.io, of San Francisco, is partnering with Ehe Health to provide saliva-based COVID-19 tests to large, self-insured employers across the country. New York-based Ehe Health will make testing kits available to its clients, enabling them to deploy private, secure and scalable onsite testing portals, foster a safer work environment and support employees as they re-enter the workplace.
Charlottesville, Va.-based Adial Pharmaceuticals Inc. received an initial firm order for the purchase of 10,000 Assure/Fastep COVID-19 IgG/IgM rapid test devices from a California-based technology corporation. As previously reported, the Fastep COVID-19 IgG/IgM rapid test device is the first serology (antibody) point-of-care test for COVID-19 using fingerstick blood samples approved by the U.S. FDA, which has issued an emergency use authorization for the Fastep COVID-19 IgG/IgM rapid test device.
Boston-based American Well Corp. (Amwell), a telehealth company, reported that it is expanding its partnership with Tyto Care Ltd., a modular device and examination platform for artificial intelligence-powered, on-demand, remote medical exams. The companies will introduce exclusive integrations and newly designed workflows and tools to enhance the ability for providers using the Amwell platform to examine and diagnose patients virtually. Additionally, Amwell will become a reseller of Tyto Care's integrated devices.
Stony Brook, N.Y.-based Applied DNA Sciences Inc. reported the signing of a master services agreement (MSA) with Stony Brook University Hospital (SBUH). Under the terms of the one-year MSA, Applied DNA will supply its emergency use authorizated Linea COVID-19 assay kit to SBUH on an as-needed basis. Concurrently, the company reported the receipt of an initial purchase order under the MSA. Terms of the MSA and initial purchase order were not disclosed.
Wetherby, U.K.-based Avacta Group plc reported that the Bams assay to detect the SARS-CoV-2 virus has been launched as a research kit by its partner, Beverly, Mass.-based Adeptrix, and the assay has been presented by Bruker Scientific, of Billerica, Mass., in a new application note.
Mechelen, Belgium-based Biocartis Group NV received a €1.2 million (US$1.41 million) grant from Vlaio, for the development of the Genefusion assay on its Idylla diagnostics platform.
Amsterdam-based Biogx BV, the European subsidiary of Birmingham, Ala.-based Biogx, reported the availability of a CE-IVD marked test for simultaneous detection of SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus RNA in a patient sample using the BD Max system. The BD Max system, commercialized by of Franklin Lakes, N.J.-based Becton, Dickinson and Co. (BD), is a fully integrated and automated molecular diagnostic platform already in use at thousands of laboratories worldwide.
San Diego-based Bionano Genomics Inc. reported that its Saphyr system has been adopted through reagent-rental agreements by two institutions in Australia and Slovenia: the Royal North Shore Hospital in Northern Sydney, New South Wales, Australia; and the University Medical Center Ljubljana in Ljubljana, Slovenia. Both hospitals aim to assess Saphyr’s potential for diagnosing leukemias vs. current standards of care, including karyotyping, chromosomal microarray and fluorescence in situ hybridization.
Billerica, Mass.-based Bruker Corp. unveiled the recent acquisition of the Integrated Proteomics Pipeline (IP2) search engine and proteomics workflow software platform. IP2 was developed by San Diego-based Integrated Proteomics Applications Inc. Financial details of the transaction were not disclosed.
Lexington, Mass.-based Cbset Inc., a not-for-profit translational research institute, said that its preclinical study, “Balloon-based drug coating delivery to the artery wall is dictated by coating micro-morphology and angioplasty pressure gradients,” has been published in the November 2020 Journal of Biomaterials.
Cellsafe, a specialist in developing diagnostics located at the Republic of Korea, and Dynasty Castle Investments Ltd., a Hong Kong-based company specializing in the procurement, distribution and delivery of medical supplies, have signed an exclusive distribution agreement for Portugal and six African countries for the sale and distribution of LAMPlex RT-qLAMP COVID-19 detection assay, real-time reverse transcription loop-mediated isothermal amplification (LAMP) technology-based kit that can detect the novel coronavirus within 25 minutes.
Westlake Village, Calif.-based Decision Diagnostics Corp. (DECN) signed an agreement with a certified U.S.-based testing partner to undertake a feasibility study and required testing for FDA emergency use authorization (EUA) and CE Mark certification, as well as with the Russian Federation for submission of the Genviro! COVID-19 saliva swift kit. The company expects the lab to report its results to DECN, which will include these results in its upcoming FDA EUA applications in the fourth quarter.
Cardiff, U.K.-based Ekf Diagnostics said that the novel viral transport media Primestore molecular transport medium has been successfully evaluated for effective SARS-CoV-2 inactivation in a new study published by Public Health England.
Electrocore Inc., of Basking Ridge, N.J., said that the Department of Veterans Affairs (VA) has agreed to sponsor a quadruple blind, randomized, sham-controlled clinical trial of noninvasive vagal nerve stimulation (nVNS) in mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD). The trial is being sponsored by the VA Office of Research and Development at the Atlanta VA Medical Center. The study, which plans to enroll 100 veterans, is designed to assess the clinical and physiological effects of nVNS in patients with mTBI and PTSD. The study’s primary outcome measures include assessments of the veterans’ clinical improvement, several objective measurements of brain activity, and changes in the levels of the inflammatory cytokine interleukin-6 in response to stress.
GE Healthcare, of Chicago, reported the launch of the AI Dream project, a consortium that gathers French small and mid-size enterprises, startups, research labs and clinical centers to facilitate the development of artificial intelligence (AI) in medical imaging. Supported with €13 million (US$15.2 million) by the Investments for the Future program, led by the French General Secretariat for Investment and operated by Bpifrance, AI Dream aims at improving diagnosis accuracy, patient’s care pathway and efficiency of health care systems.
Lantheus Holdings Inc., of North Billerica, Mass., reported the submission of a new drug application (NDA) to the U.S. FDA for PyL (18F-DCFPyL), a prostate specific membrane antigen-targeted positron emission tomography imaging agent for prostate cancer. The NDA includes a request for priority review, which, if granted, could shorten the FDA’s review of the NDA to six months from the time of acceptance vs. the standard review timeline of 10 months from acceptance. The company expects to receive notification from the FDA confirming acceptance of the filing for substantive review in early December.
Neuromaker, the STEM (science, technology, engineering and math) education arm of Somerville, Mass.-based Brainco Inc., is partnering with Vinci Robotics Academy, a 501(c)(3) nonprofit that operates STEM educational programs in the greater Boston area. Neuromaker STEM initiatives create middle and high school solutions that introduce real-world applications of neuroscience, brain machine interfaces, artificial intelligence, advanced prosthetics and more.
Opgen Inc., a precision medicine company with headquarters in Gaithersburg, Md., and Holzgerlingen, Germany, said the German government has awarded a grant to its subsidiary, Curetis GmbH, and collaborators at the Research Campus Infectognostics. The project is coordinated by Jena University Hospital and designed to use artificial intelligence-based assay development for carbapenem resistance based on porin loss and efflux pump overexpression in Gram-negative bacteria. It is slated to run from September until August 2025, with overall funding of more than €350,000 (US$410,000).
Purdue University researchers have begun a study to determine if continuously collected biometric smartwatch data, such as heart and breathing rates, could be used to detect changes that might indicate a person should get tested for COVID-19. Data from the study will be used by Physiq Inc., a Purdue-affiliated digital health company based in Chicago, to inform the development of new algorithms.
Secaucus, N.J.-based Quest Diagnostics Inc. released three new combined COVID-19 and respiratory virus tests. The new test options include the Cobas SARS-CoV-2 & Influenza A/B, an automated, high-throughput, multiplex, real-time polymerase chain reaction (RT-PCR) assay from Roche, which was granted U.S. FDA emergency use authorization (EUA) earlier this month. Two additional test panels from Quest, the Respiratory Viral Panel test and the Respiratory Pathogen Panel, now include testing for SARS-CoV-2 using the company’s SARS-CoV-2 RT-PCR test, which received FDA EUA in March to diagnose COVID-19.
Siemens Healthineers AG, of Erlangen, Germany, and Raleigh, N.C.-based Wakemed Health & Hospitals, have forged a 10-year partnership to transform care delivery and improve patient outcomes through robotics initiatives, advanced imaging capabilities and artificial intelligence, as well as provider and staff training.
San Francisco-based Spire Health reported that the first patient has been enrolled in the University of Rochester Medical Center’s A-SPIRE heart failure study using Spire Health Tags. The study will evaluate the use of the wearable physiological sensors to identify heart failure patients at risk of hospital readmission. The prospective study will enroll 100 heart failure patients at their time of discharge from the hospital and monitor their respiration, pulse and activity for 30 days using Spire Health Tags.
T2 Biosystems Inc., of Lexington, Mass., said the Biomedical Advanced Research and Development Authority, part of HHS’ Office of the Assistant Secretary for Preparedness and Response, has exercised its first contract option valued at $10.5 million. The option was exercised under a multiyear contract, valued at up to $69 million if all options are exercised, following completion of the base option to advance development of three products: a direct-from-blood panel to detect biothreat pathogens such as B. anthracis, F. tularensis, Y. pestis, burkholderia spp and R. prowazekii; a direct-from blood panel to cover up to 99% of all bloodstream infections by means of ≥36 results, including pan-Gram positive and pan-Gram negative results; and a next-generation high-throughput instrument.
The Targetcancer Foundation reported the first patients enrolled in the TRACK study to research genomic testing in people with rare cancers. The foundation is conducting the study in partnership with Foundation Medicine, of Cambridge, Mass., and with support from Leverkusen, Germany-based Bayer AG.
Todos Medical Ltd., of Rehovot, Israel, has entered an exclusive branding and distribution agreement with Australia-based Melbourne Biotech to supply high complexity CLIA laboratories in the U.S. with 96- and 384-well real-time polymerase chain reaction (RT-PCR) machines. Todos intends to focus the initial deployment of Melbourne RT-PCR machines on its mobile high-complexity CLIA lab project, which it expects to reach commercialization stage early in the fourth quarter of this year.
Southborough, Mass.-based Veristat Inc. has launched a virtual, flexible and customizable clinical research organization that enables patient interactions at the clinic, remotely at home or via a hybrid strategy.
San Diego-based Xifin Inc. has released Xifin RPM 12 to expedite workflow and improve financial performance for diagnostic providers amid the COVID-19 pandemic.