Arbor Biotechnologies Inc., of Cambridge, Mass., and Visp, Switzerland-based Lonza AG have entered a license agreement to provide Lonza with access to Arbor’s next-generation CRISPR-based gene editing technology. Financing details of the agreement were not disclosed.
Boulder, Colo.-based Biodesix Inc. said it has begun a biomarker study to affirm the importance of its Nodify Xl2 test clinical decision-making. The randomized, blinded, controlled study will assess how clinical decision-making is affected by the introduction of Nodify Lung test results into risk assessment. The study will focus on new, incidentally identified patients with lung nodules that are estimated to have low-to-moderate risk of lung cancer using the current standard of care. The study is aligned with recommendations from the 2018 American Thoracic Society policy statement on the early detection of lung cancer.
Minneapolis-based Celcuity Inc. reported a clinical trial collaboration with Massachusetts General Hospital and Puma Biotechnology Inc., of Los Angeles. The open-label phase II study will evaluate the safety and efficacy of Puma’s drug, Nerlynx (neratinib), and Faslodex (fulvestrant, a drug made by Astrazeneca plc, of Cambridge, U.K.), in previously treated metastatic HR-positive and HER2-negative breast cancer patients selected with Celcuity’s Celsignia HER2 activity test.
New York-based Deerfield Management Co. has launched the X-Seed Award, a new program designed to support early-stage life science startups. Each year, the company selects five teams that will be awarded a total of up to $500,000. Award winners will be women and other minority founders in New York City.
Luxembourg-based Eurofins Scientific said it has launched COVID-19 polymerase chain reaction tests with at-home, self-sampling options in Europe and is donating sequencing capacity to identify the VUI-2020-12/01 strain reported to spread faster in the U.K.
Excalibur Healthcare Services Ltd., a London-based medical supplies company, said it is rolling out independent COVID-19 testing programs built on its Rapid SARS-CoV-2 antigen test. The Medicines and Healthcare Products Regulatory Agency-registered test has 100% sensitivity on highly infectious people and 99% on moderately infectious. Visual results are observed within three minutes for highly infectious individuals and within 15 minutes for lower viral load infections.
Cleveland-based Identitysensors Biologics said it has developed technology that detects COVID-19 RNA in saliva through electronic nanosensors, significantly reducing error rates associated with chemical-based home tests. The company’s over-the-counter self-test, which can be performed entirely at home, is in the final stages of development at Purdue University.
Iridex Corp., of Mountain View, Calif., said its Micropulse transscleral laser therapy, performed using the Iridex Cyclo G6 laser system and Micropulse P3 delivery device, has been included in the European Glaucoma Society terminology and guidelines for glaucoma.
San Francisco-based software company Ixlayer Inc. unveiled multilingual support for COVID-19 testing and vaccine monitoring, including Spanish, French and Italian.
Lgc Maine Standards, the brand name for Cumberland Foreside, Maine-based Maine Standards Co. LLC and an entity of Lgc Clinical Diagnostics, reported the release of Validate Il-6 to meet the linearity and calibration verification needs of clinical laboratories running the Cobas platform offered by Roche Holding AG, of Basel, Switzerland.
Mogene LC, of St. Louis, said it launched a comprehensive saliva-based COVID-19 testing service as a part of its return-to-work coronavirus testing support program in the U.S. While Mogene is focusing on employers in Missouri, the COVID-19 test also will be available nationally to nursing homes, assisted living facilities, physician offices and pharma companies seeking to screen patients for the coronavirus before admission into clinical trials.
Orasure Technologies Inc., of Bethlehem, Pa., said its Omnigene·Oral collection device was included in the U.S. FDA emergency use authorization amendment granted to 3B Blackbio Biotech India Ltd., a provider of real-time polymerase chain reaction tests based in Bhopal, Madhya Pradesh. The EUA amendment will allow 3B Blackbio’s North American distributor, Somerset, N.J.-based Genophyll Enterprises, to expand saliva COVID-19 PCR-based viral diagnostic testing across the U.S., as well as from its upcoming New Jersey-based laboratory.
Palantir Technologies UK Ltd., of London, signed a new two-year contract worth up to £23.5 million (US$31.5 million) with the U.K.’s National Health Service (NHS). Palantir Foundry will provide a software platform for the secure, reliable, and timely processing of data to enable NHS decision-makers to best plan use of resources and improve patient care.
New York-based Pwnhealth LLC, a national clinician network, reported an expansion of its COVID-19 testing initiative. Since April, Pwnhealth’s platform has supported more than 10 million COVID-19 polymerase chain reaction, antibody and antigen tests. The company said it is tripling its capacity over the coming months.
Solutions in Critical Care, of Allendale, N.J., said it has partnered with Nanotronics Health LLC, of Brooklyn, N.Y., to distribute Nhale in the U.S. The noninvasive respiratory support device has received emergency use authorization for the treatment of COVID-19 patients.
Sorrento Therapeutics Inc., of San Diego, reported that an emergency use authorization application has been submitted to the U.S. FDA for its Covi-Stix rapid diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples.
Todos Medical Ltd., of Rehovot, Israel, entered a preferred vendor agreement to supply COVID-19-related testing products and services to Natural Wellness Clinics, of Louisville, Ky., for use in its initiative to test the uninsured population in Kentucky.
Natural Wellness Clinics Corp., of South San Francisco, reported plans to offer a synthetic RNA control that includes the new variant of SARS-CoV-2 circulating in the U.K. and South Africa. The company said it expects the new control to be available for customers by Jan. 15, 2021.