The prospective, observational clinical trial is aimed at determining the test’s sensitivity and specificity in detecting lung cancer over a 12-month and additional 24-month period. Credit: Shutterstock / create jobs 51

California-based biotechnology firm, Freenome, has launched a new trial in a bid to gain approval for its cancer screening tools in the US market.

The trial, dubbed the PROACT LUNG study (NCT06122077) is looking to enrol 20,000 potential patients over the age of 50 at high risk of developing lung cancer, and who are eligible for screening with a low dose computerised tomography scan (LDCT), to validate the company’s own lung screening test.

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The prospective, observational clinical trial is aimed at determining the test’s sensitivity and specificity in detecting lung cancer over a 12-month and additional 24-month period with the results set to form the basis of Freenome’s attempts to acquire market approval from the US Food and Drug Administration (FDA).

The trial is also looking to ensure some demographic and geographic diversity among trial participants with it set to take place at up to 100 sites across the US.

Lance Baldo, chief medical officer of Freenome, said: “Despite treatment advances, lung cancer remains the deadliest cancer worldwide, in part because it is often detected late.

“Freenome is answering the call for better screening tools with a test that identifies the diverse range of biomarkers associated with this highly heterogeneous cancer. Our expanding healthcare partnerships will increase access to these improved tools.”

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It follows after the company partnered with German pharmaceutical group, Merck in 2022 for a trial that sought to determine the molecular features of disease severity in a subpopulation of non-small lung cell cancer (NSCLC) patients.

It also comes alongside a series of other studies launched by Freenome including a 2020 study alongside Novartis, as well as its ongoing Vallania study (NCT05254834) which seeks to contrast blood samples from cancer cases and non-cancer control participants to establish the test’s efficacy.

The announcement follows after the  FDA announced that it is considering plans, set to come into force in 2024, that would see Laboratory Developed Tests (LDTs) regulated as medical devices proposing to alter regulations to make explicit that In Vitro Diagnostic Products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act. In June of 2023, Freenome also announced that it will work with US supermarket and pharmacy chain, Walgreens, to advance  clinical trials by engaging Walgreen  customers and encouraging participation in the company’s cancer screening studies.