Prenetics Owned ACT Genomics Receives FDA Clearance for ACTOnco, the First Asia-Based Company to Receive Clearance for a Comprehensive Genomic Profiling Test for All Solid Tumors


Prenetics Global Limited a leader in genomic and diagnostic testing, today announced that ACT Genomics, a company which Prenetics recently acquired a majority stake in, has received clearance from the U.S. Food and Drug Administration (FDA) for ACTOnco, the company’s comprehensive genomic profiling test for solid tumors. ACTOnco is intended for use by healthcare professionals to help them inform clinical management decisions in accordance with professional guidelines for cancer patients with solid tumors. This is the first and only Asia-based company to receive FDA clearance for a comprehensive genomic profiling test. ACTOnco is a diagnostic test which:

• provides a comprehensive genomic profiling test that looks at 440 cancer-associated genes;
• provides information to help guide clinical management decisions on the use of targeted oncology therapies, including immunotherapies;
• is intended as a pan-cancer test including breast, colon, endometrial, lung, and other cancers;
• is an FDA-cleared platform for comprehensive genomic profiling assay development for biopharma companies developing precision therapeutics.

The ability to perform a comprehensive genomic profiling test on an individual tumor helps open the door for personalized medicine, and a future where a person is matched with a treatment that targets the specific weaknesses in his or her cancer.

"Today’s landmark clearance by the FDA represents a significant advancement in personalized cancer care in Asia and may lead to reimbursement and coverage by private insurers and healthcare systems. The clearance by the FDA further validates our status as a pioneer in the industry and we will continue to invest further in R&D efforts, especially related to early detection of cancer in healthy populations,” said Danny Yeung, Chairman of ACT Genomics and Chief Executive Officer of Prenetics.

Dr. Hua Chien Chen, Chief Executive Officer of ACT Genomics, said, “It was a tremendous team and scientific effort to develop ACTOnco. Asia contributes 48% of the new cancer cases and 55% of the cancer deaths in the world. The disease imposes a serious burden on Asia. While precision medicine provides an advantage in disease diagnosis and treatment planning and has become a routine clinical practice in the west, it is not the case in Asia. ACT Genomics is the first biotech company in Asia that received market authorization for a cancer comprehensive genomic profiling assay. Unlike most of the currently marketed tests developed by US companies using mainly clinical samples from Western countries, the ACTOnco assay was developed and validated using half of the Western clinical samples and half of the Asia clinical samples. ACTOnco enables physicians to gain better insights into the genetic underpinnings of each patient’s illness and helps them to formulate the best treatment decisions. Having ACTOnco cleared by the FDA will open new opportunities for patients to get the best cancer care. With this incredible milestone achieved, we will continuously promote precision medicine in Asia and our company mission to turn genomics into action.”