FDA Clears Genomic Profiling Test for Solid Tumours
On January 10th, 2023, the genomic and diagnostic biotech company Prenetics Global announced that it had received regulatory approval from the US Food and Drug Administration (FDA) for the ACTOnco genetic profiling test for solid tumours.
The diagnostic test analyses 440 distinct types of cancer-associated genes and provides decision-making support for clinicians on the use of targeted oncological and immunotherapeutic treatments. The ACTOnco is a pan-cancer test used to treat solid tumours, including breast, colon, lung, endometrial, and many more.
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With its ability to perform a genomic profiling analysis on individual tumours, the technology signifies an impressive step towards unlocking opportunities for personalised medicine in cancer treatment. The ACTOnco will help work towards actively matching a treatment to target the exact weakness of an individual cancer.
News of the regulatory approval makes Prenetics the first company in Asia to receive FDA clearance for a comprehensive genomic profiling test. Prenetics acquired ACT Genomics, the precision oncology company responsible for developing the ACTOnco, in December 2022.
In an official press release statement, Chairman of ACT Genomics and Chief Executive Officer of Prenetics, Danny Yeung said: “Today’s landmark clearance by the FDA represents a significant advancement in personalised 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.”
Clearance of the comprehensive genomic profiling test is set to improve and impact the continued R&D investment into the early detection of cancer.
Chief Executive Officer of ACT Genomics, Hua Chien Chen, also stated that “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.”
Clearance of the comprehensive genomic profiling test is set to improve and impact the continued R&D investment into the early detection of cancer. What’s more, the hope is that such innovation will lead to improved liquid biopsy testing and improve routine clinical practice.
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