Present screening procedures are done mostly through physical examination or imaging (e.g. mammography), which often detects cancer only after it is well established. MultiGEN foresees cancer-detection tests using <10 ml of blood to identify circulating cancer markers at a very early curative stage. Presently, there are no other platform technologies other than MultiGEN that can achieve this objective. MultiGEN’s novel AFNA platform technology detects cancer-specific genetic markers (e.g. demethylation, cancer mutations) from any bodily fluid (e.g. blood) and clinical samples (e.g. stool) with greater accuracy than any other known or foreseen test platforms.
The objective of a biopsy of a malignancy has widened to include detection of chemotherapeutic-associated cancer markers. These include K-ras and EGFR for lung and colon cancers, and B-raf for melanoma. However, current technology does not allow these tests to achieve the desired clinical sensitivity. MultiGEN’s ASMS platform technology has 1000X greater sensitivity than the best current technologies, enabling the detection of multiple markers simultaneously, with a wild type marker as internal control. The higher the sensitivity, the greater the chance of detecting mutations, particularly with a heterogeneous mixture of normal cells and cancer cells. Further, the higher sensitivity of MultiGEN assays eliminates the need for the cell enrichment process, which saves cost and eliminates the possibility of not detecting clonal variants.
Following initial treatment with surgery, radiation, and/or chemotherapy, cancer management programs involve follow-up examinations to determine whether cancer at the primary site is cured with no secondary malignancies. While it would be ideal to detect circulating tumor cells or their remnants in the blood to monitor for the possible reoccurrence of malignancy, there are presently no effective technologies to do so. Novel features of MultiGEN’s tests are expected to satisfy clinical expectations for routine blood testing for the presence of molecular markers associated with specific cancers. Vigilance enabled by MultiGEN technology will provide an early indication of malignancy reoccurance.
MultiGEN’s technology offers the promise of dramatically enhanced cancer detection, chemotherapy treatment, and post-treatment monitoring.