Vermillion (www.vermillion.com) and Quest Diagnostics (www.questdiagnostics.com) got FDA approval for their OVA1TM Test, the first blood test that that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery. The test is a multiplexed assay simultaneously testing for five ovarian cancer biomarkers−Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) and then using an algorithm to look for specific pattern to come up with a prognosis. The test in conjunction with other clinical tests will help physician and patients make right choices about the possible treatment and help in reducing mortality rate.
Ovarian cancer is 8th most common cancer among women excluding skin cancer. According to FDA, in 2009 approximately 21,550 new cases of ovarian cancer will be detected and 14,600 deaths will reported as a result of ovarian cancer. Early detection of ovarian cancer is critical because ovarian cancer has a 5-year survival rate of 93 percent when detected early the 5-year survival rate falls to 18 percent for late stage disease.
I have written extensively in my Blog about several multiplexed Assays/biosensing devices under development all targeted toward improving diagnosis or prognosis of diseases and it is nice to see something moving out of Research Lab to a Clinical Laboratory.
In the end it is all about saving lives.