Applied DNA Sciences Inc., of Stony Brook, N.Y., said that its wholly owned diagnostics testing subsidiary, Applied DNA Clinical Labs LLC , has completed all compliance and clinical data submissions required under the Clinical Laboratory Evaluation Program (CLEP) administered by the New York State Department of Health’s (DoH) Wadsworth Center to secure a clinical laboratory permit to conduct COVID-19 testing. Upon approval of certain submissions by CLEP, the company anticipates an on-site inspection by DoH personnel in the coming weeks that, if successful, would complete the permitting process. Certification as a CLEP-approved clinical lab would initiate the launch of the organization's testing-as-a-service offering that will use the Linea COVID-19 SARS-CoV-2 Assay Kit, to enable clinical testing of patient samples.
Utrecht, Netherlands-based Cergentis BV, a genomics company that develops kits and services based on its Targeted Locus Amplification (TLA) technology, reported the expansion of its product portfolio with new service packages for cell line development: clonality assurance package and genetic stability package. These packages rely on Cergentis' TLA technology for transgene and integration site sequencing and provide reliable, single-nucleotide information on the genetic composition of producer cell lines.
Kansas City, Mo.-based Cerner Corp. reported that a new collaboration with Seattle-based Amazon that allows consumers to easily connect vital health and well-being information with their broader health care teams. The Amazon Halo, a new service dedicated to helping customers improve health and wellness, can connect to Cerner’s technology where individuals can opt-in to share activity, sleep, body fat percentage and other important wellness data from the comfort of their home. Wearable technology, such as the Amazon Halo, can help achieve greater interoperability across health care when integrated directly into a patient’s electronic health record. Longtime Cerner client Sharp Healthcare is the first health system to implement Amazon Halo in the health care setting.
Herndon, Va.-based Iron Bow Technologies, an information technology solutions provider to health care, government and commercial markets, reported the formation of a strategic relationship with Viinetwork, Inc. (dba Viimed), a Washington-based virtual care platform company. The partnership combines Iron Bow’s 10 years of telehealth and virtual care solution and services expertise with Viimed’s workflow-centric virtual care platform to deliver on the promise of next-generation virtual care solutions for enterprise organizations.
Lunit, a South Korean medical AI software company, reported a partnership with Lakeway, Texas-based Emergent Connect LLC, a provider of cloud-based PACS software. This partnership will bring AI solutions to Emergent Connect's imaging cloud customer base, allowing AI to be more easily accessible to its clients.
San Carlos, Calif.-based Natera Inc. revealed a collaborative agreement with Mass General Cancer Center of Massachusetts General Hospital, related to an investigator-initiated multicenter, phase II randomized clinical trial of Kisqali (ribociclib), a CDK4/6 inhibitor, for the treatment of ER-positive breast cancer. The company said it is the first circulating tumor DNA (ctDNA)-based study of a CDK4/6 inhibitor in ER-positive early stage breast cancer. Natera's Signatera test will be used to determine patient enrollment eligibility based on presence of ctDNA via longitudinal monitoring and to evaluate response based on ctDNA clearance as the primary endpoint.
Novacyt Group, which has a presence in Vélizy-Villacoublay, France, and Camberley, U.K., reported the launch of its CE-mark approved polymerase chain reaction respiratory test panel, Winterplex. The Winterplex test panel includes two gene targets specific to COVID-19, as well as gene targets for influenza A&B and respiratory syncytial virus.
Owlytics Healthcare, of Ramat Gan, Israel, entered a definitive service agreement with a global pharma vendor. The service will provide continuous motion and physiological personal functionality monitoring of neurology disease patients as part of a multisite clinical study conducted in the U.S., Europe and additional sites.
Rewalk Robotics Ltd., of Yokneam, Israel, said the U.S. Court of Appeals for the Frist Circuit has dismissed a class action lawsuit filed against the company in 2017. The complaint alleged that Rewalk violated the Securities Act of 1993 and Securities Exchange Act of 1934 by misrepresenting itself in the company’s initial public offering in 2014 and in public statements made following the IPO. In dismissing the case, the court affirmed the lower court decision citing the plaintiffs’ failure to state a claim regarding the Securities Act and lack of standing to bring the Exchange Act claims.
Hudson, N.Y.-based mobile health technology company Utm:Healthcare has released My Medcheck, a free smartphone app that can help consumers track key medical indicators of serious respiratory infections, such as COVID-19. Consumers can download the My Medcheck app from Apple’s App Store or the Google Play app store. More health metrics are expected to be added in future updates.
Viewray Inc., of Oakwood Village, Ohio, reported that Genesiscare Foundation’s Compassionate Access Programme is now accepting patients for treatment on the Mridian MRI-guided radiation therapy system. The program, in collaboration with the University of Oxford, is available to eligible National Health Service patients with localized pancreatic cancer and is designed to improve access to precision radiotherapy in the U.K.
Vitanova Biomedical Inc., of San Antonio, has received a $225,000 Small Business Innovation Research grant from the National Science Foundation to conduct research and development on its light-activated intracellular acidosis-targeted cancer therapy.
Richland, Wash.-based Vivos Inc. said that, based on the recommendation of its medical advisory board, it has decided on treating nonresectable cancerous lymph nodes, particularly in the head, neck and lungs, as the initial indication for use of its Radiogel therapy. Radiogel is an Yttrium-90-based injectable therapy device that can be administered directly into a tumor.
Austin-based Wenzel Spine Inc., a company focused on minimally invasive solutions for treating spinal disorders, has completed its acquisition of Statera Spine Inc., also of Austin, a software-enabled spine imaging analytics company. Financial terms of the deal were not disclosed.