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Angle, BioView Partner to Develop Quantitative HER2 Assay Using Circulating Tumor Cells

NEW YORK – UK circulating tumor cell firm Angle said Wednesday that it has signed an agreement with BioView to develop a liquid biopsy HER2 assay using its cell isolation technology, Parsortix, and BioView's automated microscopy systems and software.

Both the Parsortix PC1 Clinical System and BioView's HER2 FISH analysis application — which employs Abbott's PathVysion HER2 DNA probe kit — have been cleared by the US Food and Drug Administration. Angle also said it has already integrated BioView's technology into its R&D and clinical laboratories for assay development and pharma services.

The two companies will now begin a development program for a clinical HER2 assay coupling immunofluorescence detection of the HER2 protein with FISH-based assessment of HER2/neu gene amplification in CTCs harvested by Parsortix.

According to Angle, this is expected to take about a year, with the CTC firm receiving £1.2 million ($1.5 million) in revenue for its development services. Other financial terms were not disclosed.

The company cited changing market dynamics spurred by recent discoveries that HER2-low breast cancers can be responsive to new antibody-drug conjugate therapies — namely Daiichi Sankyo and AstraZeneca's Enhertu (trastuzumab deruxtecan) — even though these patients have historically failed to benefit from earlier HER2-targeted drugs.

According to Angle, this development marks a major commercial opportunity to develop a quantitative CTC-based HER2 assay. Unlike current standard-of-care tests developed for use on FFPE tissue, a CTC HER2 assay could also be used for longitudinal monitoring of HER2 status throughout disease progression, the firm added.

Given what Angle said could be significant third-party interest in a new assay for quantitative HER2 analysis, the two companies have agreed to allow for the inclusion of third parties in this project and its funding as they move into commercialization.