This weekend, there was a good overview in the Philadelphia Inquirer on OvaCheck, the controversial ovarian cancer detector that may or may not be nearing FDA approval:
Now, scribbling on his napkin, Levine suggested looking not for a single protein, but for changes in the overall pattern of blood proteins. Even if the identities of the proteins were unknown, the pattern itself would be the biomarker: “Rather than looking for the needle in the haystack of data… look at the configuration of the haystack.”
After that brunch, Levine enlisted another friend, biochemist and computer expert Ben Hitt, to come up with protein-pattern-recognition software.
Levine, Hitt, Petricoin and Liotta tried the software to see whether it could find clusters of proteins that distinguished blood samples of ovarian-cancer patients from samples of healthy women. To their joy, it worked.
But from those humble beginnings emerged a six-year saga of overoptimistic predictions, statistical errors, and ethics violations. The prognosis for OvaCheck is far from certain.
More from Cancer.gov‘s OvaCheck FAQ…