NEW YORK – Laboratory for Advanced Medicine said this week that the US Food and Drug Administration has granted breakthrough device designation for its liquid biopsy blood test to detect the presence of liver cancer at Stage I.
The company said that it previously reported data from a preliminary clinical study of its cfDNA methylation-based biomarkers for the non-invasive detection of hepatocellular carcinoma, demonstrating 95 percent sensitivity and 97.5 percent specificity. It reported the data at the Society for Immunotherapy of Cancer's annual meeting in November 2018 and at the American Association for Cancer Research's annual meeting in March 2019.
Coinciding with the breakthrough device designation, the firm said it expanded its hepatology board, adding medical doctors Robert Gish, Yujin Hoshida, and Ghassan Abou-Alfa.
Laboratory for Advanced Medicine is also broadening its offering of methylation-based blood tests. Its pipeline includes tests for the early detection of breast cancer, colorectal cancer, lung cancer, and nasopharyngeal carcinoma, and its researchers are working on discovering biomarkers for brain, ovarian, and pancreatic cancer.
Prescient Medicine Holdings subsidiary Prescient Metabiomics said this week that its LifeKit Prevent Colorectal Neoplasia Test has been granted breakthrough device designation by the FDA for the noninvasive detection of precancerous polyps and early-stage carcinomas. The test could aid in the interception of carcinogenesis and prevention of colorectal cancer, Prescient said. Using metagenomic technology, the test identifies microbial DNA and RNA biomarkers associated with neoplasia in the lower gastrointestinal tract. It uses a collection swab to analyze biomarkers from stool samples.
Precipio said this week that the department of pathology and laboratory medicine in the Perelman School of Medicine at the University of Pennsylvania has joined the company's network of academic platform partners. The partners provide their expertise in pathology-based diagnostics to physicians and their patients. Other academic members in Precipio's network include the Yale School of Medicine and the Dana-Farber Cancer Institute.
SCL Health, a multi-hospital nonprofit health system serving individuals in Colorado and Montana, announced this week that it has joined Strata Oncology's Precision Oncology Network. Through the network, eligible SCL Health cancer patients will have access to routine tumor molecular profiling, rapid interpretation of test results, and the ability to participate in local precision therapy clinical trials. SCL Health is one of two health systems in Colorado and the only one in Montana to be part of Strata's network.
DermTech said this week that its previously announced acquisition by Constellation Alpha Capital has been completed. Following the deal, the combined company effected a 1-for-2 reverse stock split, and as of Aug. 30, its common stock and certain of its warrants began trading on the Nasdaq under ticker symbols DMTK and DMTKW, respectively. All of Constellation's officers and directors have resigned, and DermTech's senior management and its board members have been appointed to serve in their current roles in the new company and on its board. John Dobak has been appointed CEO of the new firm and Matthew Posard is serving as chairman.
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