Technology

Detection and prognosis of early stage cancer is critical not only in selecting appropriate treatment, but also in lowering mortality rates among cancer patients. Cancer detection in early stages is typically performed by detecting cancer specific serum antigens. Unfortunately, cancer serum antigens are present at very low levels in early stage disease. Also, cancer antigens are not present in all patients due to heterogeneity of the disease. Detection of serum auto-antibody responses to tumor antigens provides more reliable serum marker(s) for cancer diagnosis. Serum auto-antibodies are more stable than serum antigens and may be more abundant than antigens, especially at low tumor burdens characteristic of early stage cancer.

Researchers at the University of Michigan have developed a “phage-protein microarray method to characterize auto-antibodies signatures in cancer” (N Engl J Med 2005; 353:1224-1235; United States Patent Appl. 20060014138 (2006). This promising method for the early detection and assessment of cancer is to look not for cancer, but for the immune response to cancer. There is no detection instrument that rivals the sensitivity and specificity of the immune system.

The following auto-antibody signatures have been clinically validated based on multiple clinical cohorts for multiple cancers:

  • Early detection of prostate cancer (better diagnostic than existing PSA method (AUC based on ROC* of 0.94 vs. 0.60)
  • Only serum-based method for identifying patients with aggressive prostate cancer (AUC based on ROC of 0.93)
  • Only serum-based method for identifying patients with lung cancer (AUC based on ROC of 0.92)

Receiver Operating Characteristic

The initial focus will be a prostate cancer test with both high sensitivity (90%) and high specificity (90%). The PSA test is currently used as a prostate cancer diagnostic test and it has good sensitivity (90%), but very poor specificity (< 30%) resulting in high false positive rates and many unnecessary biopsies because 70-80% turn out to be negative. A prostate cancer prognostic test to differentiate between indolent and aggressive prostate cancer to will also be developed. The second focus will be a lung cancer diagnostic test and a prognostic test. The technology also has application for a breast cancer diagnostic test and this will be pursued through a grant strategy.