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Prenetics' ACT Genomics Profiling Test for Solid Tumors Receives FDA Clearance

NEW YORK – Genomic and diagnostic testing company Prenetics Global said Tuesday that the US Food and Drug Administration has cleared ACTOnco, a comprehensive genomic profiling test for solid tumors.

ACTOnco was developed by ACT Genomics, a Taipei, Taiwan-based precision oncology company of which Hong Kong-based Prenetics acquired a majority stake in December.

The ACTOnco diagnostic test analyzes 440 cancer-associated genes to support clinicians prescribing targeted oncology therapies, such as immunotherapies. The test can be used for solid tumors including breast, colon, endometrial, and lung cancers.

The decision makes Prenetics the first company based in Asia to receive FDA clearance for a comprehensive genomic profiling test, according to the firm.

"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," said Hua Chien Chen, CEO of ACT Genomics, in a statement. Unlike most tests developed by US companies, which mainly use clinical samples from Western countries, half of the samples to develop and validate the ACTOnco assay came from Western and half from Asian countries, he said. 

Prenetics plans to continue to invest in R&D efforts related to early cancer detection, said Danny Yeung, chairman of ACT Genomics and CEO of Prenetics, in a statement.

The company's investment in ACT Genomics served as an entry point into the global precision oncology market, the firm said. Prenetics did not disclose financial terms of its agreement to acquire a majority of ACT Genomics in December, but said it would issue 19.9 million shares of its ordinary stock to ACT Genomics and pay $20 million in cash.