ANGLE reported it has enrolled over 75% of the required 200 metastatic breast cancer patients and 200 healthy volunteers of a similar age and demographic for its ANG-002 FDA clinical study.
The enrolment of patients and analysis of results are being conducted by independent cancer centres outside the company’s control. However, the clinical study and associated analytical studies are expected to be complete by the end of the first quarter CY 2019.
Studies at ANGLE’s own laboratories have provided insights that will further differentiate the Parsortix system in the market.
Andrew Newland, Chief Executive and Founder of ANGLE, said: “We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis. This would be a key step in establishing the Parsortix system as the system of choice for CTC liquid biopsy, securing a leading position in the emerging multi-billion dollar liquid biopsy market.”