There are a number of biomarkers for detecting ovarian cancer or working up adnexal masses.
If you'd like to be prepared for a tough review picking apart your new diagnostic test, get hardened up by reading the NGS MAC article about ovarian cancer tests (A58112) and the LCD (L38371). I just ran across these documents; they're from 2020.
My only point here, is when you enthusiastically bring your shiny new test and your one first publication in 40 patients to Medicare or another payer, you may get some pretty rough handling. (Many startup labs don't foresee this.)
Summarizing the NGS MAC author:
- "This is a non-coverage policy for all multi marker serum tests related to ovarian cancer testing."
Read the LCD and data review here:
Read the public comment article and the NGS rebuttals, here:
While not the only tests reviewed, two of them, Ova1 and OVERA come from Aspira Women's Health. Both have been FDA cleared.