Access Medical Labs said that it will run the Siemens Health FDA authorized reagent under the emergency use authorization at its facility in Jupiter, Fla. The new Ultra Sonic Antibody Test has demonstrated 100% sensitivity and 99.8% specificity for SARS-CoV-2 total antibodies.
Airehealth Inc., of Winter Park, Fla., said it reached a merger agreement with Breathresearch Inc., a respiratory health care company that has a presence in the San Francisco Bay area and works to detect increasing declines in respiratory health status. With this acquisition, Nirinjan Yee, Breathresearch's founder, has been named as Airehealth’s head of innovation. Financial terms were not disclosed.
Avectas, which has a presence in Cambridge, Mass., and Ireland, entered a collaborative agreement with the Simon Laboratory at University of California Davis to engage in the characterization of cells engineered with Avectas' proprietary, non-viral Solupore cell engineering platform. Under the collaboration, the Simon Laboratory will characterize cells engineered using Solupore, leveraging the school’s cell membrane characterization expertise and assays.
Oakville, Ontario-based Ehave Inc. has signed a letter of intent to acquire 51% of Mdlink Solutions Inc., of Miami, a telemedicine platform licensed for all Caribbean and Common Market countries. The company plans to use Mdlink’s artificial intelligence-based Coronavirus Screener to screen tourists, and will provide FDA-authorized COVID-19 rapid test kits via the Mdlink platform.
Luxembourg-based Eurofins Technologies reported the launch of its CE-IVD-marked Ingezim COVID 19 DR serology-based total antibody test. The company’s Eurofins Ingenasa company led the development of the test, which has a sensitivity of 100 from day 17 after symptoms onset and 99.2% specificity.
Evogene Ltd., of Rehovot, Israel, said it is participating in the CRISPR-IL consortium. Supported by the Israeli Innovation Authority as part of its Bio-Convergence program, the consortium goal is to develop Go-Genome, an artificial intelligence-powered, end-to-end system for genome editing. Evogene’s chief scientific officer, Eyal Emmanuel, will serve as the consortium’s chairman.
San Diego-based Exagen Inc. said it is conducting a prospective trial with Duke University to evaluate biomarkers – including the Avise panel and Cell-bound complement activation products (CB-CAPs) – that distinguish between changes in subsets of lupus patients with Type 2 and Type 2 systemic lupus erythematosus activity. The study design combines patient- and physician-reported measures to group patients into two main categories.
San Francisco-based Fitbit Inc. said it has obtained emergency use authorization from the U.S. FDA for a low-cost emergency ventilator to help address global needs during the COVID-19 pandemic. The automatic resuscitator, called Fitbit Flow, was inspired by the MIT E-Vent Design Toolbox and is based on specifications for rapidly manufactured ventilation systems published by the U.K.’s Medicines & Healthcare products Regulatory Authority.
Fractyl Inc., of Lexington, Mass., said the U.S. FDA has approved its IDE application for a pivotal study of Revita DMR (duodenal mucosal resurfacing) in type 2 diabetes patients treated with insulin. The prospective, randomized, double-blind, sham-controlled Revita T2Di study will enroll 300 patients at up to 35 sites globally, with about 25 sites in the U.S. The aim is to assess the treatment’s effect on glycemic control and insulin needs. The primary outcome of the study is the percentage of patients who are able to achieve target glycemic control of HbA1c less than or equal to 70% without the need for insulin at 24 weeks, compared with the sham arm.
Haemonetics Corp., of Braintree, Mass., said it has agreed to sell its Fajardo, Puerto Rico, manufacturing operations to Gvs S.p.A., of Bologna, Italy, for an undisclosed sum. Under the agreement, Haemonetics will retain intellectual property rights to its proprietary blood filters currently manufactured at the facility, while Gvs will obtain certain operating assets, including manufacturing equipment and inventory and a sublease to the plant. The deal, which is expected to close in the second quarter of 2020, also includes a long-term filter supply agreement between the two companies.
Toronto-based patient advocacy group Heart Valve Voice Canada is calling on provincial governments and health care facilities to prioritize patients with heart valve disease as elective surgeries begin to resume during the COVID-19 crisis.
Instem, a Conshohocken, Pa.-based provider of information technology solutions to the global life sciences market, said South Korea’s Biotoxtech Co. Ltd. has purchased a comprehensive package of preclinical data collection, analysis and regulatory submissions management solutions to automate and optimize study related processes at its R&D facility in South Korea’s North Chungcheong Province.
Boston-based Lyniate reported that Biointellisense Inc., of Denver, and Healthcare Integration Consulting Group, of Warren, Ohio, have leveraged Lyniate’s interoperability engines, Rhapsody and Corepoint, to streamline the complexities of health care data.
Nanologix Inc., of Hubbard, Ohio, is seeking a partner or partners for the development, U.S. FDA emergency use authorization, if required, and marketing of its sub 1-hour COVID-19 point-of-care modified-ELISA detection test. The rapid viral assay can be configured for other viruses as well, such as HIV, herpes papilloma virus and hepatitis. A home test version of the COVID-19 test could produce results in 30 minutes from a nasal or saliva sample.
Opgen Inc., of Gaithersburg, Md., reported that its collaboration with the New York State Department of Health to develop an infectious disease digital health and precision medicine platform for statewide surveillance and control of antimicrobial resistance is entering its second-year expansion phase. Having successfully achieved all of the milestones of the first-year pilot phase, Opgen will continue to work to expand the reach of the platform, increase the volume of testing, and enhance data collection.
Pluristem Therapeutics Inc., a regenerative medicine company based in Haifa, Israel, said it was selected as a member of the CRISPR-IL consortium, a group funded by the Israeli Innovation Authority. The consortium aims to develop an artificial intelligence-based system to provide users improved genome-editing workflows.
Proscia Inc., of Philadelphia, reported that Unity Biotechnology Inc., of South San Francisco, has deployed its Concentriq digital pathology platform to advance its research and development pipeline, which is focused on developing therapeutics to slow, halt or reversing diseases of aging. Unity will implement Proscia’s technology in an effort to accelerate the drug development process.
Proteintech Group Inc., of Rosemont, Ill., completed its ISO 13485 certification for medical devices. With this certification, Proteintech’s Humankine Human cell-expressed cytokines and growth factors are now available in GMP-compliant versions for use in clinical trials and commercial manufacturing.
Q2 Solutions, a Morrisville, N.C.-based joint venture of Iqvia Inc. and Quest Diagnostics Inc., reported its partnership with Thermo Fisher Scientific Inc., of Waltham, Mass., to use the Ion Torrent Genexus system. As a fully integrated, next-generation sequencing platform, the Ion Torrent Genexus system improves turnaround time and minimizes human error for genome profiling.