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FDA grants breakthrough designation to liver cancer liquid biopsy test

The Laboratory for Advanced Medicine announced via a press release that the FDA granted breakthrough device designation to its liquid biopsy liver cancer detection test.

“The FDA’s recognition of the liquid biopsy test’s potential for the early detection of liver cancer represents a significant milestone for the company,” Shu Li, PhD, chairman and CEO of Laboratory for Advanced Medicine, said in the release. “The ability to accurately detect cancer from a blood draw holds immense promise for improving the diagnosis, prognosis and monitoring of cancer. Testing for and detecting cancer earlier, even before symptoms arise, enables physicians to treat earlier and smarter, improving patient chances of survival and reducing the cost associated with treatment.”

Laboratory for Advanced Medicine previously reported data at the American Association for Cancer Research Annual Meeting in 2019 that demonstrated a 95% sensitivity and 97.5% specificity for noninvasive detection of hepatocellular carcinoma.

Additionally, the company presented data at other 2018 and 2019 society meetings that showed the liquid biopsy test had high sensitivity and specificity for the detection of breast cancer and colorectal cancer as early as stage I.

“This noninvasive way of uncovering the earliest signs of malignancy is attractive to both providers of health care services and patients alike,” Jinjie Hu, chief regulatory officer of Laboratory for Advanced Medicines, said. “With over 700,000 patients who are at increased risk for liver cancer in the United States and a 15-fold increase in 5-year survival rates when the cancer is detected at early stages versus late stages, we are honored by the FDA’s recognition and look forward to bringing this technology to the market.”

Reference: www.lamoncogroup.com