CytoDyn Inc (OTCMKTS:CYDY) revealed Monday that the US Food and Drug Administration has granted the company a meeting in August this year to discuss the company’s 510(k) application for clearance of its ProstaGene Prognostic Test.
The test is intended for use in patients who have undergone a prostate biopsy and been found to have prostate cancer by the Gleason score, which is a classification system to help determine treatment and predict the outlook for prostate cancer — the second most common diagnosed cancer among men, behind skin cancer.
Shares in CytoDyn were up slightly at $0.50 on the OTC Market.
The FDA's center for devices and radiological health (CDRH) has scheduled the face-to-face meeting for August 28.
“We are extremely grateful to the FDA for the timely action date on our recently filed 510(k) application for clearance of the ProstaGene Prognostic Test,” said CytoDyn CEO Nader Pourhassan. “The test holds the potential to aid patients and physicians in better decision-making,”
Dr Pourhassan said the company looked forward to working with the FDA to ensure it developed the ProstaGene Prognostic Test and solidified the “potential commercialization alternatives,” including partnerships.
To support its application for FDA clearance, CytoDyn said it will cite a previously published retrospective clinical study in two populations of men (79 and 139 men), a subsequent study in 130 men and a recent study of 218 men.
The Vancouver, Washington-based biotech said the test was developed by Dr Richard Pestell, the company's chief medical officer. The test became an asset of CytoDyn upon its acquisition in November 2018 of ProstaGene, a biotech company founded by Dr Pestell.
The test, which uses a gene signature and computer algorithm to create a score, could revolutionize the detection and treatment of prostate cancer at less cost while helping to maintain a patient’s quality of life.
Aggressive treatment has significant long-term side effects like incontinence, erectile dysfunction, and urinary dribbling.
Contact Uttara Choudhury at [email protected]