Update from December 2021. On December 7, 2021, FDA issued a PMA approval for the Opko 4Kscore test. This is one of very few lab-based (sole source) tests that has a PMA, rather than 510(k), approval. The approval remarks, performed solely at Bioreference.
The 4Kscore Test measures four proteins, three are forms of PSA (tPSA, fPSA, iPSA), and kallikrein-2. If I am reading the FDA approval correctly, the test incorporates age, previous biopsy, and digital rectal exam results.
Find the FDA home page for 4Kscore here. It's P190022.
Find the summary of safety and effectiveness here (36 pp).
Find the labeling here (aka package insert; 16pp).
Medicare Policy
For reasons that are lost on me (aka above my pay grade), the Noridian MAC has an LCD (non coverage) of 4KScore, even though the test is not performed in California. The LCD is titled as a MolDx LCD and appears to be currently active (L37120, effective January 2019, revised November 2019). See also billing article A57336 and "response to comments" A56191.
The active coverage is via Novitas MAC, under LCD L37792, active since March 2019.
CPT code 81539 for the Opko 4Kscore test in CY2020 had about 13,000 Part B FFS uses for about $10M at about $760 per test. This makes it about the 20th-highest-paid MAAA or molecular code in 2020.
Intended Use
The FDA intended use is pretty long:
The 4Kscore Test is an in vitro serum or plasma test that combines the results from four
immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA,
intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the
following information: a patient’s age, previous biopsy and digital rectal exam (DRE). The
4Kscore Test is indicated for use with other patient information as an aid in the decision for
prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA
and/or abnormal DRE. The 4Kscore Test is intended to aid in detection of aggressive prostate
cancer (Gleason Score >= 7/Gleason Grade Group >= 2) for whom a biopsy would be
recommended by a urologist, based on current standards of care before consideration of the
4Kscore Test.
A 4Kscore < 5.0 is associated with decreased likelihood of a Gleason score • 7 on biopsy.
Prostate biopsy is required for the diagnosis of cancer. The test is not recommended more than
once every 6 months.
The test is intended for professional use only, and is performed at a single-site BioReference
Laboratories, Inc. [Warnings include: "Prescription Use Only.")
Tracking S&E FDA Reports
The PAIGE PROSTATE AI software was de novo approved by FDA in September 2021, but as of yet, January 2022, the safety and effectiveness report isn't posted by FDA. Here. You can also track the appearance of the S&E summary for DEN200080 here on the de novo index page.
