San Diego, January 18th, 2010 -- MultiGEN Diagnostics Inc. announced today a modification of its patented MultiGEN platform technology that allows the development of tests with significantly enhanced sensitivity for predicting the efficacy of chemotherapy (Companion Diagnostics), and for detecting fetal genetic diseases using maternal blood samples.
The new platform technology Allele Specific Multiplex Sequencing (ASMS) is capable of accurately detecting variations at very low concentrations of mutated cells in genetically heterogeneous cell populations from any clinical sample. Results to date shows ASMS acheiving a sensitivity of detecting one mutation in a mixture with 1,000 normal wild type, or a ratio of 0.1%. Dr. T.V. Moorthy, CSO and Founder, stated “ASMS technology produces a single readout with two clearly separate stretches of DNA sequences from the locus in question, generated simultaneously from a mixture of normal and mutated cells”. He added, “In addition, the verifiable accuracy of sequencing, and the use of an integral internal control allows for confident result reporting”. ASMS technology can also simultaneously detect multiple mutations, bringing down the cost significantly relative to status quo methods.
In 2011 it is estimated that more than 370,000 patients in the USA will be diagnosed with lung and colon cancer, and have access to a wide range of chemotherapeutic agents. Detection of specific mutations in EGFR and K-ras is of value to predict the efficacy and side effects of chemotherapeutic agents used for these types of malignancy. Currently available tests to identify these mutations require cell enrichment of the biopsy sample using high value professional labor (micro-dissection) which increases the cost of testing to well over $6,000. Dr Joseph Voland, Medical Director, commented, “ASMS based cancer tests will eliminate the need for micro-dissection, and reduce the end price by 50%”.
Current methods of performing non-invasive prenatal diagnostic testing (NIPD) for the identification of fetal genetic disorders using maternal blood are facing significant difficulty in achieving the desired sensitivity for reliable reporting. ASMS allows the development of much more sensitive assays for non-invasive prediction of fetal sex, Rhesus status, and other inherited conditions (such as cystic fibrosis, Huntington’s disease, myotonic dystrophy etc).
MultiGEN is the only technology currently available to commercialize multiplexed DNA sequencing. “This results in many advantages” noted Dr Roger Hodkinson, Director of Clinical Affairs, “particularly verifiable accuracy, a larger number of targets per panel, enhanced clinical utility, and overall cost-effectiveness”.
Looking forward, the Company will shortly be creating a new subsidiary, MultiGEN Companion Dx, to take these test panels through FDA regulatory process.
For more information please contact Dr Moorthy at moorthy@multigen-diagnostics.com or call 858.523.1675
