CytoDyn Inc (OTCMKTS:CYDY) announced Wednesday it has requested a meeting with the US Food and Drug Administration to discuss the 510(k) application for FDA 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.
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.
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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 treatments' long-term side effects
Aggressive treatment has significant long-term side effects like incontinence, erectile dysfunction, and urinary dribbling.
“The inability to determine which cases of prostate cancer may be aggressive leads to significant and, often, unnecessary highly invasive treatment,” Dr Pestell said. “The development of an FDA-cleared prostate cancer prognostic test may aid patients and physicians in better decision-making.”
CytoDyn’s stock recently traded flat at $0.52 on the OTC Market.
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