Technology
LPL Technologies has developed a diagnostic blood test for ovarian cancer, and potentially for breast cancer. The company has established expertise in the field of bioactive lipids, which are fat-soluble molecules functioning as messengers between cells. LPL Technologies has determined that one of these molecules, LPA, is elevated in gynecological cancers. With a simple blood test, LPL Technologies can detect Stage I ovarian cancer, a condition that is invisible using existing tests. Following on their success in developing a diagnostic for ovarian cancer, the company has isolated a combination of lipids unique to breast cancer and is developing a second diagnostic assay. As they complete the large-scale clinical trial that will allow for sales of the ovarian test, LPL Technologies is already enrolling women in a clinical trial of its breast cancer diagnostic.

Ovarian Cancer
The American Cancer Society reports that 25,000 new cases of ovarian cancer are diagnosed every year. It is the most deadly gynecological cancer - not because it is the most common, but because it is difficult to diagnose at an early stage. If diagnosed and treated early, 90% of ovarian cancers are cured; thereafter, it is 80% fatal. Nearly 75% of women diagnosed with ovarian cancer find out after it is too late.

The only existing test for ovarian cancer, CA 125, is not actually approved by the Food and Drug Administration as a diagnostic, but only as a tool to monitor residual cancer in patients after surgery. The FDA restricts the indicated use of CA 125 because it has both high rates of both false positive results in a normal population and high rates of false negative results in women with cancer. Nevertheless, one half of CA 125's worldwide sales of 15 million tests in 2000 were requested by women seeking to use CA 125 as a screening test. LPL Technologies's LPA test detects ovarian cancer earlier, and far more accurately, thus LPL Technologies is applying to the FDA for more expansive claims than those allowed for CA 125. Based upon the target population size and the sales of CA 125, an annual U.S. market size of $400 million is realistic for LPL Technologies's superior LPA test.

Clinical Success
LPL Technologies has gathered blood samples from 1600 women in seven locations to demonstrate LPA's utility as an ovarian cancer diagnostic. The company is currently testing the samples; when the results are unblinded, the company will have completed the requirements for FDA approval for U.S. sales (Pre-Market Approval). LPL Technologies's confidence in the successful outcome of this study is based upon their experience with a parallel clinical trial of 600 patients already processed outside of the FDA study. An independent study, performed on 165 women and published in The Journal of the American Medical Association in August 1998, revealed elevated LPA levels were found in 90% of patients with Stage I ovarian cancer and 100% of patients with Stage II, Stage III, and Stage IV ovarian cancer.