ANGLE: FDA approval awaited, LDT data expected H122
ANGLE’s updates reveal dialogue with FDA for Parsortix’s approval for use in mBC (metastatic breast cancer) is continuing and constructive, first submissions for accreditation of UK and US clinical laboratories have been made, but development of the ovarian cancer LDT (Laboratory Developed Test) has been hampered by a delay to data read out from a key study (due to third-party supply issues) to H122. A new study comparing CTC harvest and downstream analysis against biopsies in mBC shows good correlation and indicates Parsortix use could materially benefit clinical diagnoses and treatments. The longer wait for FDA approval and first LDT roll-out prompt us to revisit our forecasts and valuation models. Our new valuation of £506m ($658m), or 215p/share compares to £581m ($755m), 248p/share previously.ANGLE is a holding company. Through its subsidiares, Co. operates as a medical diagnostic company focusing on the development of products in the fields of cancer diagnostics and foetal health. Co. develops products for use in rare cell diagnostics that enable early identification of an individual's condition for the prevention, treatment, and monitoring of disease. Co.'s principal trading activity is undertaken in relation to the development and commercialization of the Parsortix cell separation system, with deployment in liquid biopsy (non-invasive cancer diagnostics).
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