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, 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. Our Onko-Sure™ cancer test kits are currently sold in the form of a 96 well test plate, which, after standards are applied, 41 individual tests can be run in duplicate. These tests are typically run in a reference laboratory with test results determined by using a micro-titer reading analyzer. Results are sent to the attending physician who then relays those results to the patient. Typically, a patient can receive results within 3-5 days from the blood draw date. Because the Onko-Sure™ test kit is a non-invasive blood test, there are no side effects of the administration of the test. As with other cancer diagnostic products, false positive and false negative test results could pose a small risk to patient health if the physician is not vigilant in following up on the Onko-Sure™ test kit results with other clinically relevant diagnostic modalities. While the Onko-Sure™ test kit is helpful in diagnosing whether a patient has cancer, the attending physician needs to use other testing methods to determine and confirm the type and kind of cancer involved. On July 8, 2009 we changed the brand name of our in vitro diagnostic cancer test from DR-70 to the more consumer friendly, trademarked brand name “Onko-Sure™,” which we believe communicates it as a high quality, innovative consumer cancer test. We are also installing a new tag line -- “The Power of Knowing” -- which communicates to cancer patients and their physicians that the test is effective in assessing whether a patient’s cancer is progressing during treatment or is in remission. The DR-70® (FDP) test is the first new cancer test to be approved by the US FDA for monitoring colorectal cancer (CRC) since January 14, 1982 when Carcinoembryonic Antigen (CEA) was approved. Onko-Sure is more effective than CEA in patients with low CEA values. Greater than 50% of all stage CEA patients with biopsy-confirmed CRC have low CEA values; therefore, Onko-Sure should add significant clinical value for monitoring CRC patients. Strategic Advantages Simple, non-invasive blood test Standard Sandwich ELISA format New US FDA approved cancer marker Tumor Marker is abundant in serum floats-freely in blood (unlike CEA) levels rise dramatically with cancer progression (up to 38 times greater than in normal patients) International regulatory approvals Multiple clinical uses: International use as a cancer screen—verify type with other methods US approved for colorectal cancer monitoring—use to check for cancer recurrence or disease status during cancer treatment Medical Usefulness of Onko-Sure, The AMDL DR-70® (FDP) Test: Clinical data supports the medical utility of Onko-Sure, the AMDL-ELISA DR-70® (FDP) immunoassay, for the detection and monitoring of cancers in the ovaries, tongue, gastrointestinal tract, lung, breast, and colon/rectum. In the studies cited at the end of this document, Onko-Sure was used to measure FDP levels in 7,999 patients (see references on back). Within these studies, the Onko-Sure results consistently correlated with either the positive detection or positive progression of a variety of cancers. A complete list of references follows. Onko-Sure Overview How Onko-Sure Works: While the production of Fibrin and Fibrinogen Degradation Products (FDP) is restricted in healthy individuals, FDP are over produced by cancer cells, which release proteolytic enzymes such as plasmin and thrombin. Current assays for FDP usually measure a specific FDP component, such as D-dimer, as a representative of this group; whereas the Onko-SureTM test detects the full complement of FDP. Onko-SureTM acts as a “barometer for cancer” by simultaneously measuring the multiple FDP species that may be underestimated by other tests. Onko-Sure for CRC Treatment For CRC survivors, effective monitoring for disease recurrence is perhaps the most important part of an effective post-surgery treatment plan. Onko-SureTM is the first new cancer test to be approved by the US FDA for the monitoring of CRC in over 25 years. In early CRC stages (Duke’s stages A & B), between 68% and 97% of the biopsy positive patients have negative CEA values and are unable to be monitored with CEA. Onko-Sure is more effective at detection CRC recurrence than CEA in patients with low CEA values. Onko-Sure / DR-70 References 1 Schaffrath, M et al. (2006) German J Obstetrics and Gynocology 66, 68-75. 2. Lee, K.H et al. (2006) Immune Network 6, 43-51. 3. Adonis, M et al. (2005) Toxicol Lett. 159:32-7. 4. Li, X. et al. (2005) Br J Oral Maxillofac Surg 43, 513-515. 5. Adonis, M et al. (2005) Xenobiotica 35:519-30. 6. Kerber, A. et al. (2004) Aliment Pharmacol Ther 20, 983-987. 7. Rucker, P et al. (2004) Analytical Letters 37, 2965-2976. 8. Wu, DF et al. (1999) Analytical Letters 32, 1351-1362. 9. Ding, L. et al. (1999) Chongqing Med J 28, 1-3. 10.Wu, D et al. (1998) J Immunoassay 19, 63-72.