FDA Grants Breakthrough Device Designation to LAM's Novel Liver...
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FDA Grants Breakthrough Device Designation to LAM's Novel Liver Cancer Detection Test

By Pharma Tech Outlook | Tuesday, September 10, 2019

Shu Li, Ph.D., CEO, LAM

The breakthrough device designation will enable the company to streamline its development process and make the novel approach easily accessible to doctors and patients.

FREMONT, CA: Healthcare providers often find it challenging to identify liver cancer in its early stages since the symptoms start to appear only in the later stages. The liver tumors are too small to detect using physical examination approaches. For many years, Laboratory for Advanced Medicine (LAM) has strived to develop robust and innovative technologies for early diagnosis. The company recently received a breakthrough device designation by the United States Food and Drug Administration (FDA) for its liver cancer detection test.

The liver cancer detection test developed by LAM is a highly specific and sensitive blood test designed to detect the presence of cancer in the liver. It offers an accurate and noninvasive approach of care according to the current standards of care. The conventional cancer tests do not provide the sensitivity needed for early detection. The LAM approach equips the clinicians with a potent tool to detect the presence of cancer in patients with cirrhosis before it can become life-threatening. Also, the test has low false negative and false positive rate and offers reliable outcomes for a more accurate diagnosis.

The liquid biopsy blood test is designed to identify liver cancer in the early stages and promises high specificity and sensitivity. The FDA recognizes the approach to have the potential to facilitate more effective diagnosis of the life-threatening ailment. The designation will enable the company to streamline development, assessment, and review to provide faster access for clinicians and patients.

Shu Li, Ph.D., CEO of LAM, said, "We look forward to continuing helping people at high liver cancer risk by dramatically improving standard cancer screening methods using our blood-based test. The breakthrough device designation is a recognition of the benefits of our technology in detecting cell-free DNA methylation patterns to provide early and accurate information to diagnose when treatment options are favorable."

Richard A. Brand, MBA, CFO, LAM

LAM is a commercial-stage medical technology company focused on the commercialization of innovative, noninvasive, and nontoxic technologies designed for early diagnosis and intervention for cancer. It specialized in building and developing robust technologies designed to bolster the healthcare sector. LAM is headquartered in the United States, with offices in California, Indiana, and Texas.

The company collaborates with scientists, physicians, research institutions, and business leaders across the world, leveraging their expertise in developing effective and safe diagnostic technologies. LAM also has a CLIA-registered and CAP-accredited laboratory, as well as third-party laboratories and cGMP facilities striving to equip the medical community with robust and innovative technologies.

Richard A. Brand, MBA, CFO at LAM, said, "With this designation, the FDA acknowledges the public health need for more powerful and less invasive methods to diagnose liver cancer. In addition to this milestone in our efforts to detect liver cancer earlier, we recently strengthened our hepatology board with the appointment of three distinguished medical experts that will help guide further developments."

The data from the preliminary clinical study of the cfDNA methylation-based biomarkers for noninvasive detection of hepatocellular carcinoma (HCC) by LAM revealed a sensitivity of 95 percent and a specificity of 97.5 percent. The outcomes of the test were presented at the Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting and at the American Association for Cancer Research (AACR) Annual Meeting.

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