The biomarker field is a complex one, wrought with a certain amount of confusion as a result. One issue of contention right now is where the biomarkers derive from. Typically, biomarkers are taken from tumors in patients who already have cancer, but ARYC’s patented methodology allows for first-time-ever pre-symptomatic diagnosis, taking biomarkers not from tumors but from the patient’s own immunological response to preliminary indicators.
President of ARYC Dr. Mark Schena highlighted the important distinction between the industry biomarker known as CA125 and the Company’s OvaDx™ in a recent interview with the leading Proteomics periodical ProteoMonitor by saying, “OvaDx™ “allows primary screening of all women, whereas CA125 is used mainly as a monitoring tool for women who already have ovarian cancer.”
Schena was eager to point out the revolutionary change this meant for how Ovarian Cancer is detected and treated, saying that because “OvaDx™ allows early-stage, pre-symptomatic detection of ovarian cancer”, it is the first truly preventative treatment available for this type of cancer.
Schena anticipated a 4Q 2010 approval for OvaDx™ and said, in a January 15 interview with Clinica, a European medical technology publication, that he hoped “to get it reviewed on an expedited basis, as there is such an unmet need”.
The reason OvaDx™ is so profoundly different is that it can be used for screening the public in a method similar to Pap screening for cervical cancer, which has shown great results in reducing fatality rates.
Schena also told Clinica that the Company plans to CE-mark (Conformité Européene ) the test for sale in Europe after approval in the U.S., and that he hopes this test could “nip ovarian cancer in the bud” by offering a test procedure which measures “markers produced by the immune system in response to early-stage ovarian cancer”.
Schena also commented on the potential applicability of this methodology for early diagnosis of other diseases such as Prostate Cancer and Parkinson’s, saying that in the interim he was “very excited about bringing this rather revolutionary ovarian cancer test to the market”.