Laboratory for Advanced Medicine Announces FDA Breakthrough Device Designation for Liquid Biopsy Test to Detect Early-Stage Liver Cancer

On September 4, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that the medical technology company Laboratory for Advanced Medicine (LAM) announced that its liquid biopsy technology for liver cancer had received FDA Breakthrough Device designation.

Hepatocellular carcinoma (HCC) is a common form of primary liver cancer, with approximately 740,000 deaths and over 780,000 new cases annually worldwide. The disease has an insidious onset with no obvious symptoms in the early stages and progresses rapidly; patients are often diagnosed at a locally advanced stage or with distant metastasis. Consequently, HCC is difficult to treat and carries a poor prognosis. In China, more than 300,000 people die from HCC each year, accounting for approximately half of the global liver cancer mortality.

Liquid biopsy utilizes high-throughput sequencers to analyze DNA fragments in human blood. This test provides relevant information when tumor-derived or donor-derived DNA from transplanted organs is present in the body. Compared with other cancer detection methods, liquid biopsy offers several advantages: it is minimally invasive, allows for unrestricted testing timing during treatment, and enables clinicians to monitor molecular changes in tumors in real time. Furthermore, circulating tumor DNA (ctDNA) can reveal the complete molecular profile of a tumor, whereas other cancer detection methods are limited to analyzing only the sampled portion of the tumor.

LAM previously reported preliminary clinical study data on its non-invasive biomarker for hepatocellular carcinoma detection based on cfDNA methylation, showing a sensitivity of 95% and a specificity of 97.5%.

LAM, established in 2014 and headquartered in California, USA, is a commercial-stage medical technology company. The company maintains offices in Indiana and Texas. LAM collaborates with globally leading scientists, physicians, research institutions, and business leaders to provide safe and effective diagnostic technologies for patients and clinicians. The company operates CLIA- and CAP-certified laboratories in the United States, along with cGMP-certified facilities, and is committed to developing cutting-edge technologies for the healthcare community.

Dr. Shu Li, Chairman and CEO of LAM, stated, “The ability to accurately detect cancer through blood tests holds great promise for improving the diagnosis, prognosis, and monitoring of cancer patients. Through early cancer screening, physicians can initiate treatment earlier and more accurately before symptoms appear, significantly enhancing patients’ survival rates and reducing treatment costs.”

Jinjie Hu, Chief Regulatory Officer at LAM, stated, “This non-invasive method for detecting early signs of malignant tumors holds significant importance for healthcare providers and patients. There are over 700,000 liver cancer patients in the United States; if liver cancer is detected at an early stage, the five-year survival rate for these patients will increase by 15-fold. We are honored to have received FDA clearance and look forward to bringing this technology to market.”

(Compiled by Hu Yifan)