Avita Therapeutics Inc., of Valencia, Calif., enrolled the first patient in its pivotal study assessing the use of the Recell system to treat stable vitiligo. The study will evaluate the safety and effectiveness of Recell to repigment skin in patients who have vitiligo that has been stable for at least a year.
Minneapolis-based Bio-Techne Corp. and the Mount Sinai Health System in New York, through its commercial affiliate Kantaro Biosciences LLC, have launched the COVID-Seroindex, a Kantaro quantitative SARS-CoV-2 IgG antibody research use-only kit. The parties will leverage a joint commercialization and distribution team to support rapid distribution of the assay to the vaccine development community. It is expected to be available for research use this month.
Guided Therapeutics Inc., of Peachtree Corners, Ga., has shipped four Luviva Advance Cervical Scan systems and associated disposables to its Chinese co-manufacturing partner and distributor for China, Shandong Yaohua Medical Instrument Corp., of Jinan City. Shandong will use the products to support approval by China’s National Medical Products Administration.
Luminultra Technologies Ltd., of Fredericton, New Brunswick, has submitted its Genecount COVID-19 RT-qPCR Assay Kit to the U.S. FDA for emergency use authorization and to Health Canada for an interim order.
Cincinnati-based Meridian Bioscience Inc. has launched a SARS-CoV-2 antibody pair to the trimeric spike protein to speed development of COVID-19 assays from patient saliva.
Mimedx Group Inc., of Marietta, Ga., reported the release of its Epicord Expandable placental allograft. The technology’s patent-pending design allows the allograft to cover up to twice the surface area once expanded.
San Carlos, Calif.-based Natera Inc. has launched an initiative to improve care for organ transplant patients with a history of cancer, using its Signatera test for molecular residual disease assessment pre- and post-transplant in combination with the Prospera test for transplant rejection assessment.
Nevro Corp., of Redwood City, Calif., said it will establish global manufacturing operations in Costa Rica to support future growth. The company has signed a 10-year lease for a 35,000-square-foot plant, which it expects to be validate and approved in 2022.
Lake Forest, Calif.-based Staar Surgical Co. said it has completed patient enrollment in its multicenter, U.S. clinical trial of the Evo/Evo+ Visian implantable collamer lens. Primary study analysis will be conducted when 300 primary eyes complete six months of follow-up, which is expected early in the second quarter of 2021. The company will submit the study results to the U.S. FDA shortly thereafter.
Telo Genomics Corp., of Toronto, said it has launched a commercial evaluation in collaboration with Applied Spectral Imaging (ASI), of Carlsbad, Calfi., to assess the applicability of integrating GenASIs, an ASI automated imaging and analysis solutions, into Telo’s workflow.
Thermo Fisher Scientific Inc., of Waltham, Mass., reported the Thermo Fisher Precision Medicine Science Center is collaborating with Astrazeneca plc, of Cambridge, U.K., and the University of Nebraska Medical Center (UNMC) as part of its ongoing development of solutions for unmet needs in clinical biomarker discovery. Ongoing and planned studies with both Astrazeneca and UNMC will utilize standardized plasma protein profiling workflows for biomarker discovery for a range of conditions.
Transenterix Inc., of Morrisville, N.C., has established the first training center for the Senhance surgical system in the Asia-Pacific region. The center is located in Japan at the Saitama Medical University International Medical Center in the greater Tokyo area.