Cancer Diagnostics - Onko-Sure

Cancer Diagnostics

Our Onko-Sure™ in vitro diagnostic test enables physicians and their patients to effectively monitor and/or detect solid tumor cancers by measuring the accumulation of specific breakdown products in the blood called Fibrin and Fibrinogen Degradation Products (FDP). Onko-Sure™ is a simple, non‐invasive blood test used for the detection and/or monitoring of 14 different types of cancer including: lung (Oncologystat.com), breast, stomach, liver, colon, rectal, ovarian, esophageal, cervical, trophoblastic, thyroid, malignant lymphoma, and pancreatic. Onko-Sure™ can be a valuable diagnostic tool in the worldwide battle against cancer, the second leading cause of death worldwide. Onko-Sure™ serves the IVD cancer/oncology market which, according to Bio-Medicine.org is growing at an 11% compouned annual growth rate.

Onko-Sure™ is sold as a blood test for cancer in Europe (CE Mark certified), India, Taiwan, Korea, Vietnam, and in Chile (research use); approved in the U.S. for the monitoring of colorectal cancer (CRC); approved in Canada (by Health Canada) for lung cancer detection and lung cancer treatment monitoring; and in many key markets, has the significant potential to be used as a general cancer screening test.


The product is manufactured at our Tustin, California based facilities and is sold to third party distributors, who then sell directly to CLIA certified reference laboratories in the United States as well as clinical reference labs, hospital laboratories and physician operated laboratories in the international market. Our test kits are currently being sold to one diagnostic reference laboratory in the United States. Through distributors, we have limited sales of these test kits outside the United States. We have developed our next generation version of the Onko-Sure™ test kit, and in 2009 we entered into a collaborative agreement with the Mayo Clinic to conduct a clinical study to determine whether the new version of the kit can lead to improved accuracy in the detection of early-stage cancer...cont'd