Cambridge, U.K.-based Avacta Group plc said it has entered a global distribution agreement with Abcam plc, also of Cambridge, to sell the former’s SARS-CoV-2 research ELISA Affimer reagents.
Applied Spectral Imaging Inc. (ASI), of Carlsbad, Calif., and Kromatid Inc., of Longmont, Colo., are forged a strategic commercial partnership granting ASI worldwide rights to market Kromatid’s Pinpoint FISH (PPF) probes and assay services. PPF is sued by researchers to directly analyze unique and small genomic targets in tissues, microarrays and dissociated cells.
Brainchip Holdings Ltd., of Perth, Australia, said the Brainchip Research Institute has entered a research collaboration with Biotome Pty. Ltd., of West Perth, Australia, to develop antibody tests for SARS-CoV-2. Under the arrangement, Brainchip’s Akida neuromorphic processor chip will be used to interpret sensor responses and determine which responses are the most representative for protective antibodies. The aim of the Biotome research is to create a hand-held device that uses nanomaterial-based sensors in combination with the Akida chip that will give accurate results in seconds.
Nashville, Tenn.-based Cryoport Inc. has acquired Critical Transport Solutions Australia Pty. Ltd. (CTSA), a health care logistics management company headquartered in Castle Hill, Australia, for about $5 million. CTSA will become a part of Cryoport’s Cryopdp business unit and will continue to be run by the current management team.
Lee’s Summit, Mo.-based Eurofins Viacor Inc. has launched the Cpass coronavirus SARS-CoV-2 neutralizing antibody test, which aids in the identification of recent or prior infection for SARS-CoV-2. The test has been authorized by the FDA under an emergency use authorization. It can identify if a person has produced neutralizing antibodies in response to a COVID-19 infection or inoculation with a vaccine. The ELISA-based methodology detects neutralizing antibodies to the receptor binding domain of the spike protein.
Three additional Medicare Administrative Contractors (MACs) have published final Local Coverage Determinations (LCDs) providing coverage for the Heartflow FFRct Analysis, developed by Redwood City, Calif.-based Heartflow Inc. Heartflow Analysis is a noninvasive, personalized cardiac test for stable symptomatic patients with coronary artery disease (CAD). The LCDs were published by CGS Administrators LLC, WPS Government Health Administrators, and Noridian Healthcare Solutions. The published policies were finalized based on the body of clinical evidence for the Heartflow Analysis and are consistent with policies previously published by two other MACs, Palmetto GBA and National Government Services Inc. With the publication of the latest policies, patients with CAD in 38 states now have formal Medicare coverage for the technology.
Masimo Corp., of Irvine, Calif., said a study evaluating four rescue therapies on the systemic and cerebral oxygenation of mechanically ventilated COVID-19 patients with acute respiratory distress syndrome used the Masimo Root patient monitoring and connectivity platform with O3 regional oximetry to gauge impact. The researchers found that recruitment maneuvers (RMs), prone positioning, inhaled nitric oxide, and extracorporeal carbon dioxide removal had varied impact on cerebral oxygenation and the other measured parameters, noting in particular that after RMs, while there was no significant change in partial pressure of oxygen or partial pressure of carbon dioxide, there was a significant decrease in cerebral oxygen saturation. The study, which was published in Critical Care, demonstrates the importance of brain monitoring during the treatment of patients with severe COVID-19.
Motus GI Holdings Inc., of Fort Lauderdale, Fla., has submitted a 510(k) application to the FDA for a version of its Pure-Vu system for upper GI endoscopy. It is designed to integrate with therapeutic gastroscopes to enable safe and rapid cleansing during the procedure, while preserving established procedural workflow and techniques.
Molecular diagnostics platform Novel Microdevices Inc., of Baltimore, has been awarded up to $13.8 million in non-dilutive funding by the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to develop its rapid molecular test for the diagnosis of sexually transmitted bacterial infections, including Chlamydia trachomatis and Neisseria gonorrhoeae. The device will also detect antibiotic-resistant gonorrhea. The award consists of $3.6 million in initial funding with up to $10.2 million of milestone-based funding. CARB-X will also provide Novel with access to industry expertise and business consulting resources.
Nottingham, U.K.-based Oncimmune Holdings plc signed separate agreements with Basel, Switzerland-based Roche Pharmaceuticals, a unit of Roche Holdings AG, and Cedars-Sinai Medical Center, Los Angeles, to use the company’s infectious disease panel. In the Roche deal, Oncimmune will utilize its panel to profile antibody and autoantibody responses in all patient samples from the Roche COVACTA trial, set up to evaluate the safety and efficacy of tocilizumab in patients with severe COVID-19 pneumonia to look for immune signals of response, non-response and adverse events. In the agreement with Cedars-Sinai, Oncimmune provides antibody profiling in COVID-19 samples as biomarkers for the disease. Following on from this first project, Cedars-Sinai has agreed to expand its collaborative COVID-19 program to study a unique cohort of patients.
Ortho Regenerative Technologies Inc., of Montreal, has submitted an investigational new drug application to the FDA for the initiation of a phase I/II trial of its Ortho-R in rotator cuff tear repair. Ortho-R is a chitosan-platelet-rich plasma hybrid implant, designated by the FDA as a drug/biologic combination product. It is formulated and designed to augment the healing rate of occupational and sports related injuries to tendons, meniscus and ligaments.
Researchers at the University of South Florida in Tampa have received a $44.4 million grant from the NIH for the Preventing Alzheimer’s with Cognitive Training study. The grant furthers prior research that showed a small amount of cognitive training significantly reduced the risk and incidence of dementia among older adults. The computerized brain training used studies is based on the science of brain plasticity. The technology, the Brainhq app, is developed by San Francisco-based Posit Science Corp.