NEW YORK (360Dx) – Guardant Health said that its Guardant360 liquid biopsy assay has received expedited access pathway designation from the US Food and Drug Administration. The designation will allow the company to work with the FDA to finalize its data-development plan as it prepares a regulatory submission later this year, Guardant Health said. The liquid biopsy test was developed so that oncologists can select the most appropriate treatment for their patients, eliminating the need for an invasive tissue biopsy. The expedited access pathway is intended to accelerate an FDA review of breakthrough technologies and medical devices that serve unmet medical needs.
Roche said this week that it had established a strategic alliance with Wisconsin Diagnostic Laboratories of Milwaukee and selected it as a Roche Molecular Center of Excellence. Established in 2002, the Roche Molecular Center of Excellence enables non-competing regional labs across the US "to collaborate and capitalize on scientific knowledge in molecular testing and, in turn, help accelerate the advancement of new test methods and technology," Roche said. Wisconsin Diagnostic Laboratories serves more than 30 hospitals, 500 long-term care facilities, and 100 outreach practices in Wisconsin and the Chicago area, Roche added.
Immunovia said that Spain's University Hospital of Santiago de Compostela has joined PanFAM-1, a multicenter prospective validation study for the early diagnosis of pancreatic cancer in high-risk individuals using Immunovia's IMMray PanCan-d blood test, which is based on antibody biomarker microarray analysis. Professor Enrique Domínguez-Muñoz will lead the team at the University Hospital of Santiago de Compostela. PanFAM-1 now includes Mount Sinai Health System; Knight Cancer Institute at Oregon Health and Sciences University; Massachusetts General; University of Liverpool; Ramon y Cajal Institute for Health Research in Madrid; and Sahlgrenska University Hospital in Sweden.
The College of American Pathologists has accredited Diagnomics’ San Diego laboratory. It had already been CLIA certified in 2015. Achieving both designations will enable the company to expand into new diagnostic markets, including NIPT, cancer screening, clinical sample management, and trial support, Diagnomics Chairman Min Seob Lee said in a statement.
Avalon GloboCare said that its GenExosome Technologies subsidiary has launched US operations with new headquarters in Ohio. The firm plans to market and distribute its exosome isolation systems out of the new location. The systems are designed for biomarker discovery, clinical diagnostic development, and the advance of targeted therapies, the firm said. GenExosome currently has research kits and services available to isolate exosomes or extract exosomal RNA and protein from serum, plasma, urine, and saliva samples.
Abbott’s board of directors declared a quarterly dividend of $.28 per share payable May 15, 2018, to shareholders of record at the close of business on April 13, 2018.
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