Original from: 360DX

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.

Source: Angle, BioView Partner to Develop Quantitative HER2 Assay Using Circulating Tumor Cell