FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is that current screening methods that rely on detecting high levels of prostate specific antigen (PSA) in the blood are notoriously unreliable. High PSA levels may be a sign of not only prostate cancer but infection, inflammation or other disease. Another problem with current PSA PSA testing is that it over detects for low-grade cancer that don’t pose a threat to the patient but result in unnecessary biopsies or treatment that does more harm than the actual cancer.

The New Blood-Based PSA Test

On Oct. 17, 2019, Cleveland Diagnostics, Inc., a company partly owned by the Cleveland Clinic dedicated to developing next-generation diagnostic tests for early cancer detection, announced that it has received FDA breakthrough device for a test that uses a new and more accurate methodology for detecting prostate cancer risk: The so-called IsoPSA test doesn’t simply measure PSA levels but evaluates structural changes to the PSA protein allowing for more accurate differentiation between cancer and non-cancerous conditions; it is also capable of identifying whether cancer detected is serious and needs to be treated or benign enough to be left under “active surveillance.” Securing FDA breakthrough designation expedites the approval process and brings Cleveland Diagnostics significantly closer to its goal of getting final approval to market the test in the U.S. in 2020.

Genetic Tests for Early Prostate Cancer Detection

When and if it reaches the market, IsoPSA faces competition from commercially available genetic tests using biomarker detection and algorithm technologies to assess a patient’s risk of prostate cancer and avoid unnecessary biopsies. Such products include:

• Prostate Health Index (PHI) (Beckman Coulter), which uses a mathematical formula calculating prostate cancer probability by combining PSA, free PSA and p2PSA tests into a single score;
• 4Kscore (OPKO Health), which calculates a patient’s percentage risk for aggressive prostate cancer by combining four prostate-specific kallikrein assay results with clinical information in an algorithm;
• SelectMDx (MDxHealth), a urine test that measures the expression of two mRNA cancer-related biomarkers that, when combined with the patient’s clinical risk factors, provides a score assessing whether patient needs a biopsy or active surveillance;
• ExoDx Prostate (IntelliScore), aka, The EPI Test (Exosome Diagnostics), which analyzes a urine sample for three biomarkers of aggressive prostate cancer and uses an algorithm to assess the results and generate a score for use in determining whether a biopsy is necessary; and
• Mi-Prostate Score (MiPS) (Michigan Medicine), which combines the amount of serum PSA with the amounts of two genes for prostate cancer in the patient’s urine for early prostate cancer detection PROGRAMS AND PART

New FDA Approvals

Here’s a look at other new FDA product approvals announced between late October and mid-November:

NEW FDA APPROVALS

New CE Marks & Global Certifications

Notable European CE certifications announced during the period:

NEW CE MARKINGS IN EUROPE

Other international clearances announced during the period: