Profile image
By ProactiveInvestors (Reporter)
Contributor profile | More stories
Story Views
Last Hour:
Last 24 Hours:

CytoDyn requests FDA meeting to discuss clearance of prostate cancer-detection test

% of readers think this story is Fact. Add your two cents.

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. 

READ; Breakthrough test predicts which HIV patients will respond to CytoDyn’s leronlimab as a monotherapy

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.  

Contact the author: [email protected]

Follow him on Twitter @PatrickMGraham

Story by ProactiveInvestors

Support BeforeitsNews by trying our natural health products! Join our affiliate program
Order by Phone at 888-809-8385 or online at
Get our Free Ebook, "Suppressed Health Secrets" THEY don't want you to know!

APeX - Far superior to colloidal silver!  Desroys Viruses, Bacteria, Pathogens!
Ultimate Curcumin - Natural pain relief, reduce inflammation and so much more.
Supreme Fulvic - Nature's most important supplement! Vivid Dreams again!
MitoCopper - Bioavailable Copper destroys pathogens and gives you more energy.
Oxy Powder - Natural Colon Cleanser! Cleans out toxic buildup!
B-12 - Supports healthy metabolism, brain function, hormone balance!
Nascent Iodine - Promotes detoxification, mental focus and thyroid health.
Never Wax Your Car Again -
Protects vehicles for years with dazzling shine!
Smart Meter Cover - Reduces Smart Meter radiation! See Video!
Prodovite - The Secret To Healing is in the Blood!

Tactical Laser Blinds
Bring Batteries Back
New Laser Blinds Attackers Instantly! Bring Dead Batteries Back to life!
US Faces 100 Year Drought
Cut Power Bills by 65%
NASA - US Faces 100 Year Drought! Discovery Can Cut Power Bills by 65%
Report abuse


    Your Comments
    Question   Razz  Sad   Evil  Exclaim  Smile  Redface  Biggrin  Surprised  Eek   Confused   Cool  LOL   Mad   Twisted  Rolleyes   Wink  Idea  Arrow  Neutral  Cry   Mr. Green




    Email this story
    Email this story

    If you really want to ban this commenter, please write down the reason:

    If you really want to disable all recommended stories, click on OK button. After that, you will be redirect to your options page.