Allied Bioscience Inc., of Plano, Texas, said its Surfacewise2 coating received EPA approval for a public health emergency exemption waiver submitted by the Texas Department of Agriculture. Surfacewise2, a non-toxic coating applied via an electrostatic spray, was approved for use to continuously protect against SARS-CoV-2 with a single application. The company said it is pursuing this emergency waiver across all 50 states.
Beckman Coulter, of Brea, Calif., reported the launch of its Access SARS-CoV-2 IgM assay. The new IgM antibody test demonstrated 99.9% specificity against 1,400 negative samples and 98.3% sensitivity at 15-30 days post-symptom onset.
San Diego-based Bionano Genomics Inc., the developer of the Saphyr genome imaging platform, has acquired Lineagen Inc., a Salt Lake City, Utah-based genetic diagnostic company. Bionano paid approximately $9.6 million in consideration for Lineagen, consisting of 6,167,510 shares of Bionano’s common stock, approximately $1.7 million in cash and assumption of approximately $2.9 million in liabilities. Concurrent with the closing of the merger, Bionano also paid approximately $1.1 million to satisfy outstanding principal and accrued interest amounts due pursuant to a Paycheck Protection Program loan issued to Lineagen under the Coronavirus Aid, Relief, and Economic Security Act. Lineagen was advised by Evolution Life Science Partners in connection with the merger.
Clinical Laserthermia Systems AB (CLS), a Lund, Sweden-based developer of image-guided laser ablation technology for minimally invasive soft tissue and cancer tumor treatment, and Advanced Medical Systems Pte. Ltd. (AMS), a Singapore-based provider of medical devices and services for the Asia-Pacific region, have entered a collaborative agreement. Through the joint venture company Clinical Asia Pacific Pte. Ltd., CLS and AMS will launch the Tranberg thermal therapy system and Imilt treatment protocol in the Asia-Pacific market.
Diomics Inc., a San Diego-based biotech company, said it is developing the Diocheck Antibody Indicator, which provides a simple way for individuals to monitor for the presence of antibodies to SARS-CoV-2 over an extended period. Diocheck will be able to detect and report within 24 to 36 hours whether a person has developed a circulating level of SARS-CoV-2-specific antibodies. A positive response causes a visible change to the Diocheck skin patch, which resembles a nicotine patch and is expected to be effective for up to 14 days. The Diocheck system is expected to move from preclinical to human clinical trials in late September 2020.
Lumiata Inc., of San Mateo, Calif., is partnering with Fgc Health, of Winnipeg, Manitoba, to use Lumiata’s artificial intelligence predictive models to identify high-risk patients. The collaboration will give Fgc Health to ability to provide its customers with proactive interventions, the companies said.
San Diego-based Nex Cubed is teaming up with Enterprise Singapore, a government agency, to support Singapore-based digital health startups that are interested in expanding to the U.S. market. Under the partnership, Nex Cubed will run its Innovation Launchpad Program to support up to 16 Singapore digital health startups in two cohorts, with a focus on preparing them for U.S. market entry.
Charlotte, N.C.-based Nn Inc. has agreed to sell its life sciences division to affiliates of American Securities LLC, of New York, for the purpose of being combined with its portfolio company, Mw Industries Inc., a provider of springs, specialty fasteners and precision components based in Rosemont, Ill. Under the definitive agreement, the life sciences division will be purchased for $825 million, including $755 million in cash payable when the transaction closes and an additional $70 million earnout payable in cash based on the division’s 2022 performance. The deal is expected to be completed in the fourth quarter of 2020.
Qiagen NV, of Hilden, Germany, released its access Anti-SARS-CoV-2 Total test in the U.S., following FDA emergency use authorization. The easy-to-use digital test is done on a portable device to detect antibodies to the virus that causes COVID-19, with results provided in about 10 minutes.
Singapore-based Restalyst Pte. Ltd. said it has developed a COVID-19 antibody test comparable to market leaders. In a study using 387 clinical samples, comprising 56 RT-PCR positive and 331 healthy cohort for COVID-19, COVID19n-Reaad had an estimated clinical sensitivity and specificity of 98.2% and 100%, respectively. The test was validated through comparative studies with the U.S. FDA-authorized serological tests Advia Centaur SARS-CoV-2 Total from Munich-based Siemens AG and the Elecsys Anti-SARS-Cov-2 from Roche Holding AG, of Basel, Switzerland.
Terumo Cardiovascular Systems Corp., of Elkton, Md., a subsidiary of Tokyo-based Terumo Corp., is partnering with Cytosorbents Corp., of Monmouth Junction, N.J., to sell Cytosorb to hospitals in 10 U.S. COVID-19 hotspot states: Alabama, Arizona, California, Georgia, Louisiana, Mississippi, New Mexico, Oregon, Texas and Washington. Cytosorb previously received emergency use authorization from the U.S. FDA for use in adult, critically ill COVID-19 patients with imminent or confirmed respiratory failure.
Todos Medical Ltd., of Rehovot, Israel, reported a nearly $1.3 million contract to supply a Texas-based laboratory with polymerase chain reaction (PCR) testing equipment and accessories. The agreement also gives Todos a priority right to supply the lab with up to 75,000 COVID-19 PCR tests per day in the event of a significant increase in testing demand.
Austin-based Xbiotech USA Inc. said the U.S. FDA’s granted emergency use authorization for COVID-19 convalescent plasma (CCP) opens the door for use of its antibody screening technology to identify CCP. The company collaborated with Biobridge Global, of San Antonio, to develop the test. The latter is using Xbiotech’s test to identify convalescent plasma in patients who have recovered from COVID-19.