U.K.-based Avacta Group plc reported it is shipping Affimer reagents for COVID-19 antigen testing to its diagnostic test development partners. The company recently reported that it had generated multiple, highly specific Affimer reagents that bind the SARS-COV-2 viral antigen and do not cross-react with SARS, MERS and other closely related coronaviruses. These Affimer reagents will be used to develop a point-of-care saliva based COVID-19 antigen test strip by Cytiva for CE marking and FDA approval.
Avita Medical Ltd. of Melbourne, Australia, reported that the Australian Securities and Investments Commission (ASIC) has registered the scheme booklet in relation to the proposed scheme of arrangement under which Avita Therapeutics Inc. will become the parent company of the company and its subsidiaries for the purposes of effecting a redomiciliation of the Avita Group from Australia to the U.S. The reason for the company seeking this relief was to reduce the substantial costs, burden and risks associated with the dual financial reporting and related compliance obligations that the company currently has in both the U.S. and Australia as a result of being treated (since Dec. 31, 2019) as a domestic public company in both of these jurisdictions for financial reporting purposes.
Franklin Lakes, N.J.-based Becton, Dickinson and Co., (BD) reported it has stopped selling a point-of-care test, developed by Morrisville, N.C.-based Biomedomics Inc., touted as being able to detect antibodies to COVID-19 in as little as 15 minutes. The test, by Biomedomics, was one of about 100 serological tests that the FDA allowed manufacturers to sell beginning March 26, via emergency use authorization (EUA), if the companies self-validated their accuracy. The agency did not require the companies to submit reports of the results of their validation efforts. On May 4, the FDA reversed its policy, saying manufacturers of COVID-19 antibody tests must prove the tests’ accuracy to the agency before they can begin marketing them. The agency gave companies already selling tests 10 days to submit their validation information or risk having the tests pulled from the market. BD spokesman Troy Kirkpatrick told BioWorld MedTech that given the latest guidance from the FDA, BD has suspended distribution of the current test. He noted that Biomedomics has completed development of a second generation of the test and is currently coordinating validation activities. Kirkpatrick added that Biomedomics intends to submit a new EUA application to FDA once the second-generation test has successfully completed all validation testing.
Cantel Medical Corp., of Little Falls N.J., reported that given the significant uncertainty related to the COVID pandemic, the company is withdrawing its financial guidance for fiscal year 2020.
Capsule Technologies Inc., of Andover, Mass., and Yale New Haven Health System have teamed up to provide Capsule’s Ventilated Patient Surveillance workstation for real-time monitoring COVID-19 ventilated patients.
Boston-based Caresyntax Inc. said it is expanding its partnership with Diversified Inc., of Mukilteo, Wash., to accelerate the launch of multiple surgical telepresence and proctoring solutions during the COVID-19 pandemic.
Clinone Inc., of Greenwood Village, Colo., is expanding its strategic collaboration with Denver-based Biointellisense Inc. to combine continuous health monitoring and clinical intelligence with the Clinone Clintrialconnect patient portal platform. The addition of the FDA-cleared Biosticker and Biobutton single-use medical devices aims to provide an effortless and improved trial participant experience for continuous temperature and vital sign monitoring of symptoms associated with COVID-19.
Endologix Inc., of Irvine, Calif., said it has completed enrollment in the EVAS2 confirmatory clinical trial to assess its Nellix Endovascular Aneurysm Sealing (EVAS) system. In response to the COVID-19 outbreak and delays in patient recruitment for clinical trials, Endologix submitted an IDE supplement to the FDA with a revised statistical analysis plan proposing a minimum of 95 patients. The study’s two-year effectiveness endpoint is from 93.8% to 87.4%. The company plans to submit a premarket approval application after the first 95 patients reach one-year follow-up in March 2021.
Charlotte, N.C.-based Honeywell International Inc. has unveiled a new temperature monitoring tool, Thermorebellion, that incorporates advanced infrared imaging technology and artificial intelligence algorithms to conduct noninvasive, preliminary screening of people entering a building.
Laboratory Corporation of America Holdings, of Burlington, N.C., reported that its COVID-19 at-home collection test kit is now available to individuals nationwide who have either have symptoms of the novel coronavirus or may have been exposed. The test, which can be accessed through the Pixel by Labcorp online platform, was originally limited to frontline health care workers and first responders.
Lifescan Inc., of Malvern, Pa., and New York-based Noom Inc. are collaborating on a pilot program integrating Lifescan’s Onetouch Reveal app with Noom’s digital diabetes and weight loss management program. The program will include select Onetouch patients with type 2 diabetes and track clinical outcomes, as well as patient experience and satisfaction.
Rochester, Minn.-based Mayo Clinic and Ultromics Ltd., of Oxford, U.K., are teaming up to use the latter’s artificial intelligence software, Echogo Core, to analyze echocardiograms of COVID-19 patients for clues about how the virus affects the cardiovascular system. The goal is to provide a roadmap for cardiac features seen with COVID-19 and improve triaging and treatment of high-risk patients.
Medtek21, of West Chester, Pa., and Houston-based Accessdx Laboratory LLC reported the availability of a COVID-19 testing and compliance tool for nursing homes and adult care facilities within New York state impacted by Executive Order 202.30, “Continuing Temporary Suspension and Modification of Laws Relating to the Disaster Emergency.”
Minerva Surgical Inc., of Redwood City, Calif., reported the closing of the acquisition of Marlborough, Mass.-based Boston Scientific Corp.'s intrauterine health franchise. Minerva's combined product line will provide health care practitioners with a product portfolio for treating abnormal uterine bleeding.
Natera Inc., of San Carlos, Calif., said that Noridian had issued positive coverage for the Prospera donor-derived cell-free DNA (dd-cfDNA) test. Noridian also announced it is developing a generic policy for dd-cfDNA testing that will include multiple commercially available tests under one consistent policy.
Natus Medical Inc., of Pleasanton, Calif., reported a partnership with Holberg EEG AS, of Bergen, Norway, designed to advance the development and distribution of an Autoscore algorithm to automate electroencephalography (EEG”) classifications and improve reporting efficiency.
Irvine, Calif.-based Nihon Kohden (NK), reported the launch of its NK-Healthprotect Patient Triage Solution, which includes the necessary tools to help evaluate patients potentially suffering from COVID-19.
Bethlehem, Pa.-based Orasure Technologies Inc. reported that its Diversigen and Corebiome subsidiaries have combined their microbiome service offerings under the Diversigen name.
Prevencio Inc., of Kirkland, Wash., reported a research collaboration with Seattle Children’s Research Institute leveraging the company's artificial intelligence (AI) expertise in developing blood tests. Seattle Children’s sought to partner with Prevencio to develop a test for Kawasaki Disease, a rare but fatal childhood disease, which can be triggered by COVID-19. Seattle Children’s will provide blood samples to Prevencio, which will use its Hart AI platform to develop a blood test. Prevencio retains exclusive world-wide rights. Additional terms of the deal were not disclosed.
Procisedx, of San Diego, reported its 510(k) filing for Procise CRP test. The company said its test measures C Reactive Protein (CRP) levels from fingerstick whole blood in two minutes. It also reported the appointment of Jacques Cavadenti, vice president of international.
Protxx, which has a presence in California and Calgary, Alberta, reported product development and pilot deployment collaborations and supporting investments focused on integrated diagnostic/therapeutic applications of the its precision health care platform. In collaboration with researchers at the University of Calgary Human Performance Lab (UCHPL), Protxx has recently demonstrated the ability to integrate both diagnostic and therapeutic functions into its wearable devices in order to enhance the management of neurodegenerative medical conditions. The newly announced collaborations and investments will drive product prototyping of the integrated device with Newark, Calif.-based Triple Ring Technologies and pilot testing at UCHPL.
Rewalk, which has a presence in Berlin, Marlborough, Mass., and Yokneam, Israel, reported a binding offer to Deutsche Gesetzliche Unfallversicherung - German Social Accident Insurance to provide qualified spinal cord injury patients with the Rewalk 6.0 robotic exoskeleton device.
Dallas-based Spotsee is providing hands-off forehead thermometers for essential businesses and companies to help ensure workplaces remain fever and virus free throughout the U.S. as businesses plan to reopen in the coming weeks.