ANGLE hails watershed moment of Parsortix FDA submission in 2020

ANGLE PLC (LON:AGL) (OTCQX:ANPCY) has hailed the full De Novo submission of its Parsortix system to the US Food and Drug Administration (FDA) in 2020 as “a watershed moment” for the company and its goal to achieve the first-ever FDA clearance for a system to harvest cancer cells from patient blood for analysis. In its results for the year to December 31, the biopsy specialist also noted that an ovarian cancer clinical verification study in progress with a leading US cancer centre, headline results from which are expected in the fourth quarter of 2021. READ: Angle completes recruitment for key ovarian cancer study Meanwhile, ANGLE said post-year end it has launched clinical labs in the UK and US and initiated a global pharma services business, adding that it also signed its first large-scale pharma services contract with an oncology-focused pharma customer utilising the Parsortix system. Looking to the numbers for the year, the company reported revenues of £0.8mln, up from £0.6mln in 2019, while losses for the year were £11.6mln reflecting planned investments, compared to a loss of £7.6mln in the prior year. The firm also said it had ended the year with a cash balance of £28.6mln compared to £18.8mln in 2019, and that it had raised £19.6mln during the year from institutional investors. Looking ahead, ANGLE said it is planning to establish a test for ovarian cancer around the end of 2021, which it said will address “a large unmet medical need”, adding that it has continued to gather momentum in 2021 and will accelerate the commercialisation of its biopsy platform. "ANGLE adapted to [coronavirus] related disruption and successfully completed the work required to make the full De Novo FDA Submission for the Parsortix system. This marked a watershed moment for ANGLE in its goal to achieve the first ever FDA clearance for a system to harvest cancer cells from patient blood for subsequent analysis, initially in metastatic breast cancer”, ANGLE chairman Garth Selvey said in a statement. “It was encouraging that FDA's Additional Information Request was received without undue delay despite the ongoing pressure on FDA resources as a result of COVID-19. Whilst recent communication with FDA indicates a potential delay to their review processes, our response, which will be comprehensive, is expected to be submitted in May 2021, with a regulatory decision from FDA anticipated during [the second half of] 2021. “ANGLE continues to gather momentum and, through its new services business, has begun to accelerate commercialisation of its unique liquid biopsy platform to support personalised cancer care. I look forward to the coming year with confidence", he added.