20/20 Bioresponse, a business unit of Rockville, Md.-based 20/20 Genesystems Inc., said it is accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits.
Northvale, N.J.-based Adm Tronics Unlimited Inc. (ADMT) said that Origin Inc., of Princeton, N.J., filed an IDE application with the U.S. FDA to conduct clinical studies to treat patients diagnosed with COVID-19 with its plasma-generated nitric oxide (NO) technology. ADMT has developed and manufactured for Origin the Ionojet, which aims to allow for the targeted delivery of NO generated by a thermal plasma, produced from room air at the point of therapy.
Columbia, Md.-based Ambu Inc. has won a national contract in the category of single-use endoscopes with a group purchasing organization. The agreement enables Ambu to serve about 20% of the acute care hospitals in the U.S.
Anpac Bio-Medical Science Co. Ltd., a biotechnology company with operations in China and the U.S., has obtained three grants and one rental award from various local authorities in China with a portion of the funding subject to milestone achievements. In total, these grants and award reached about $8 million. Grant and award payments or benefits are expected to be received over a few years and will help the company fund R&D and new product commercialization.
Irvine, Calif.-based Capillary Biomedical Inc. has received a $1.5 million program-related investment in the form of a loan from The Leona M. and Harry B. Helmsley Charitable Trust. The funds will fuel clinical studies of the company’s Steadiflow technology to assess the potential for extended wear of insulin infusion sets by people with type 1 diabetes for seven days and longer.
Cb2 Insights, of Mississauga, Ontario, completed the asset acquisition of Maverick County Medical in Eagle Pass, Texas. The acquisition expands the company’s bricks and mortar and telemedicine services to 14 states and adds 10,300 new patients to its current roster of 100,000.
San Diego-based Decipher Biosciences said that Evicore Healthcare, of Bluffton, S.C., updated the Clinical Guidelines for its Lab Management Program to incorporate Decipher Prostate into its coverage criteria for prostate cancer patients with adverse pathology following surgical removal of the prostate who are being considered for radiation therapy.
Scottsdale, Ariz.-based Electromedical Technologies Inc. reported its uplisting to the OCTQB Market.
Ellume Ltd., of Brisbane, Australia, reported a $30 million phase 2 award from NIH’s Rapid Acceleration of Diagnostics (RADx) initiative to accelerate the clinical testing and manufacturing of three COVID-19 antigen tests. The fluorescent immunoassay-based tests are designed for three distinct uses: at-home, point-of-care and laboratory settings. Each delivers results in less than 15 minutes.
Madison, Wis.-based Exact Sciences Corp. and New York-based Pfizer Inc. have extended and amended their agreement to promote Cologuard, an FDA-approved noninvasive stool DNA screening test for colorectal cancer. Under the terms of the nationwide agreement, Pfizer will continue to provide marketing and related support for Cologuard and join Exact Sciences’ efforts to educate patients, physicians and health systems about Cologuard.
San Diego-based Exonbio LLC has launched its SARS-CoV-2 Spike recombinant monoclonal antibodies for the development of antigen assays and therapeutics for COVID-19.
Imagin Medical Inc., of Vancouver, British Columbia, has selected Boston-based Lighthouse Imaging LLC as the contract manufacturer for its i/Blue imaging system.
West Palm Beach, Fla.-based Imed Surgical LLC has filed a federal lawsuit against Dror Paley, founder and director of the Paley Orthopedic and Spine Institute, of West Palm Beach, Orthex LLC, a wholly owned subsidiary of Orthopediatrics Corp. based in Lakewood Ranch, Fla., Orthopediatrics Corp., of Warsaw, Ind., and Squadron Capital LLC, of Granby, Conn. The complaint, filed in the U.S. District Court for the Southern District of Florida, accuses Paley of misappropriating trade secrets and confidential information used to duplicate Imed’s patented and copyrighted technologies for the development of the Orthex External Fixation System and related software using Point and Click technology.
Oncimmune Holdings plc, of Nottingham, U.K., said it has received U.K. government funding to support a joint collaboration with Medicines Discovery Catapult, of Alderley, U.K., to deliver the IMmunity Profiling of pAtients with COVID-19 for Therapy and Triage (IMPACTT) program. The collaboration will focus on enabling better treatment for patients according to their immune profile.
Polarean Imaging plc, of Durham, N.C., has submitted a new drug application and request for priority review to the U.S. FDA for hyperpolarized Xenon gas used to evaluate pulmonary function and to assess the lung using magnetic resonance imaging.
Amsterdam-based Royal Philips NV and Lequest BV, of Rotterdam, are partnering to provide online interactive training for the Philips Ultrasound Affiniti system.
Qosina Corp., of Ronkonkoma, N.Y., has teamed up with Resolution Medical LLC, of Fridley, Minn., to offer a 3D-printed sterile nasal swab for COVID-19 testing.
Wavre, Belgium-based Oncomfort SA, the developer of Digital Sedation – a drug-free method for relieving patients’ pain and anxiety, and Vygon SA, an Ecouen, France-based provider of single-use medical devices, reported a partnership for the commercialization of Sedakit, the Digital Sedation virtual reality solution, in Europe. Vygon will introduce the Sedakit in France, the U.K., Ireland, Spain, Portugal and Italy beginning in 2021.
Quanterix Corp., of Billerica, Mass., entered a phase 2 contract with the NIH through its Rapid Acceleration of Diagnostics (RADx) initiative. The RADx contract, which has a total award value of $18.2 million, will accelerate the continued development, scale-up and deployment of a SARS-CoV-2 antigen test based on Quanterix’s Simoa technology.
Sonic Healthcare USA, of Austin, Texas, reported it has launched a multiplex RT-PCR assay in the U.S. that combines testing for SARS-CoV-2 and influenza A/B with a single specimen collection.
Synthace Ltd., the London-based developer of the cloud-based software Antha, said it launched a new software capability for streamlining enzyme-linked immunosorbent assay (ELISA). Antha now allows researchers to flexibly design and execute automated ELISA protocols and gather, structure, and analyze the data in an accessible, in-depth format.
Rehovot, Israel-based Todos Medical Ltd., reported it has entered an exclusive supply agreement with mobile CLIA laboratory company Integrated Health LLC, of Baton Rouge, La. Integrated Health is operating Motopara Foundation Inc.’s mobile biosafety level 3-built laboratories, which were developed to address the COVID-19 pandemic.
New Zealand-based Ubiquitome Ltd. said it signed an NIH Rapid Acceleration of Diagnostics (RADx) contract. Ubiquitome will use the funds to scale its portable Liberty16 RT-PCR technology to test for COVID-19 in U.S. hospitals and mobile labs. Ubiquitome is one of the first companies outside the U.S. to be awarded a RADx contract.