LabCorp reps are visiting offices to hawk OvaSure a new ovarian cancer screening test. The need for an ovarian cancer screening test is huge. Ovarian cancer is a tremendous problem because although it affects relatively low numbers of women each year it often presents at an advanced incurable stage. A screening test for ovarian cancer therefore is welcome and overdue. I have not personally been impressed by the performance of CA-125 as a screening test and pelvic ultrasound is invasive and not very effective either. Enter OvaSure. It's a blood test that profiles a series of six markers (leptin prolactin osteopontin insulin-like growth factor II macrophage inhibitory factor and CA-125) and detect ovarian cancer with 99% specificity and 95% sensitivity. Oh. My. Goodness. Reports of CA-125 sensitivity have it at 72%. This means that adding five other markers to the CA-125 adds 20+ points of sensitivity to the test without adversely affecting specificity. A little hard to believe but ok I'm willing to give it a chance. There is a peer-reviewed paper: Diagnostic markers for early detection of ovarian cancer; Visintin I. et. al. Clin Cancer Res. 2008 Feb 15;14(4):1065-72. Epub 2008 Feb 7. There is even a statement from the Society of Gynecological Oncologists (SGO): OvaSure's interesting but not ready for prime time. Here's the thing: we've been down this road before. A few years ago a guy named Lance Liotta went around the country claiming that he had a blood profile test that could detect ovarian cancer with 99% accuracy. Sound familiar? Turned out it probably wasn't true and there was commercial bias to taint the story as well. The journal Science ran a fascinating profile on the story a few months ago. I think this is why SGO is so conservative here: fool me once shame on you fool me twice shame on me. I think that's right--there needs to be more than one paper on this. A phase III study is due at the end of 2008. Also there are two other multi-marker assays entering commercial availability: OvaCheck and a test called OVA1. Are we going to see an all-out marketplace battle until only one of these three tests remains? The OvaSure test is only $300 which to me seems a bargain in this age of high-priced tests. I personally prefer my test accuracy numbers in terms of the AUC-ROC which are less dependent upon negative and positive cutoffs than sensitivity and specificity (in case anybody from Clinical Cancer Research is reading). With very good numbers like we have on OvaSure the AUC-ROC is going to be excellent but it's still nice to see the number in the abstract. So I think if you wanted to test a patient or two to see how things go on OvaSure no problem. If you are considering offering it to every person in your office probably wait for the confirmatory studies. I have discussed the test with a few patients in the past several days and there has been a high degree of excitement with it. We generally take about ten years to really learn how to use a new technology whether it be heart cath Rituxan or ovarian cancer screening tests. I welcome a new potentially life-saving technology into the clinic but let's understand what we're getting ourselves into.