Angle Working Toward FDA Approval of CTC Isolation Platform for Breast Cancer Testing

NEW YORK (GenomeWeb) – UK-based diagnostics firm Angle has made strides over the past year in its goal to become the first to bring an unbiased, epitope-independent circulating tumor cell diagnostic through the US Food and Drug Administration, the firm said in a recent update to investors.

Circulating tumor cells have been somewhat overshadowed in recent years by the excitement over tests that, instead, detect circulating cell-free DNA molecules, and early iterations of CTC technologies that failed to demonstrate adequate clinical sensitivities across cancer types didn’t do much to stem that tide.

But researchers and commercial firms are now starting to demonstrate that with the right technology to extract and isolate CTCs, analyzing the genomic or other molecular features can have diagnostic value.

Unlike the first FDA-approved CTC capture technology, Menarini-Silicon Biosystems’ Cellsearch, Angle’s Parsortix uses a patented microfluidic technology with a disposable cassette to capture and harvest CTCs from blood, based not on specific expression markers but on their less-deformable nature and larger size compared to other blood components.

Angle Founder and CEO Andrew Newland said in an interview this week that the firm has now completed most of its internal analytical validation of the system, demonstrating its technical

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