Franklin Lakes, N.J.-based Becton, Dickinson and Co. (BD) and Los Angeles-based Scanwell Health Inc. reported a collaboration to create an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app. As part of the collaboration, BD plans to produce a lateral flow antigen test and pair it with the Scanwell Health mobile app. The app is expected to provide step-by-step instructions on how to collect and transfer a nasal swab sample and use the mobile device's camera to analyze and interpret results. The test result will be displayed onscreen, and the companies are also planning to develop functionality to assist in automated reporting to public health agencies. This approach is intended to provide an efficient and scalable rapid antigen home testing solution.
New York-based Brainstorm Cell Therapeutics Inc. recently met with senior leadership from the U.S. FDA and received feedback on a high-level data summary from the Nurown (autologous MSC-NTF cells) amyotrophic lateral sclerosis phase III clinical trial. The FDA concluded from their initial review that the current level of clinical data does not provide the threshold of substantial evidence that FDA is seeking to support a biologics license application (BLA). In addition, the FDA advised that this recommendation does not preclude Brainstorm from proceeding with a BLA submission.
San Carlos, Calif.-based Gala Therapeutics Inc. reported a U.S. FDA conditional investigational device exemption approval to commence its pivotal clinical trial called Rhesolve, which is designed to evaluate the Rheox bronchial rheoplasty system for chronic bronchitis. The Rhesolve trial is a double-blind, randomized, sham controlled study in chronic obstructive pulmonary disease (COPD) patients with moderate to severe chronic bronchitis. The study will randomize 270 subjects in a 2:1 ratio at up to 40 U.S. centers and up to 10 international centers. The trial will assess the safety and efficacy of the Rheox system when used to treat the symptoms of chronic bronchitis. The primary efficacy endpoint is the change from baseline to 6 months in the COPD Assessment Test score.
Boulder, Colo.-based Lightdeck Diagnostics said it has been awarded a $5.65 million contract from the Biomedical Advanced Research and Development Authority, part of HHS’ Office of the Assistant Secretary for Preparedness and Response, to develop a rapid antigen test to detect SARS-CoV-2, the virus that causes COVID-19. The funds will enable Lightdeck to develop a point-of-care antigen test that delivers results in less than six minutes, the company said.
Medica Group, of Hastings, U.K., and Integral Diagnostics Ltd., of Melbourne, Australia, have created a joint venture, Medx, to provide teleradiology reporting services and increased reporting capacity in Australia, New Zealand, the U.K. and Ireland.
Mediwound Ltd., of Yavne, Israel, has launched a new clinical development program to evaluate its drug product candidate MWPC005 in patients with non-melanoma skin cancer. Mediwound recently submitted a protocol to the FDA for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma (BCC) and is preparing to initiate this study in the U.S. in the second quarter of 2021. A phase II investigator-initiated trial of MWPC005 in non-melanoma skin cancer will be conducted in parallel at the Soroka Medical Center in Israel. Mediwound expects data from both studies will be generated by the end of 2021.
Houston-based Nuprobe Inc. has released its Varmap Pan-Cancer NGS Panel, which uses the quantitative blocker displacement amplification technology to enrich, detect and quantitate more than 6,500 mutations and indels in 61 clinically relevant genes. The panel can be used on cell-free DNA samples to detect mutations down to 0.1% variant allele frequency (VAF) using only 1 million next-generation reads. It can also be applied to formalin-fixed paraffin-embedded tumor samples or other cellular samples for minimum residual disease detection, detecting mutations down to 0.01% VAF.
Paragonix Technologies Inc., of Cambridge, Mass., reported the first-in-man use of its Lungguard donor lung preservation system by Duke University Hospital.
New York-based Pavmed Inc. said its majority-owned subsidiary, Lucid Diagnostics Inc., intends to spin off into a separate public company, either through an IPO or a merger with a health care special purpose acquisition company. The company also reported that Lucid is launching an initiative to accelerate Esoguard commercialization by targeting multiple sales and marketing channels and building Lucid’s own network of Esocheck operators to assure sufficient testing capacity at its facilities. A pilot program in one major metropolitan area is planned for the second quarter of 2021. Meanwhile, Paymed subsidiary Solys Diagnostics Inc. has advanced research and development on licensed, noninvasive glucose monitoring technology, and has advanced its own noninvasive glucose monitoring. The company plans to focus on its technology and mutually unwind the license agreement.
Oslo-based Pre Diagnostics AS said its Preadx immunoassay for early detection of Alzheimer’s disease has successfully completed a clinical evaluation. The company plans to further optimize the assay in advance of CE marking in the second quarter of 2021.
Seaspine Holdings Corp., of Carlsbad, Calif., reported the limited commercial launch of its 3D-printed Waveform TA (TLIF articulating) interbody implant system. The device represents the first 3D-printed lumbar system and follow the September 2020 launch of the Waveform C interbody implant system, designed for use in anterior cervical discectomy fusion procedures.
Spineway SA, of Écully, France, is partnering with Tsunami Medical Srl, of Modena, Italy, for the sale of Twin Peaks interbody cages produced with 3D printers.