Multigen Diagnostics Inc.

MultiGEN Diagnostics offers multiplexed assays based on a novel modification of the ‘Gold Standard' Sanger sequencing method. The MultiGEN platform provides the most accurate, cost effective and comprehensive bio-informatics for molecular diagnostics, drug development and personalized medicine (Companion Diagnostics). Custom designed assays are our specialty. All products and services are based on our patented intellectual properties. Novel MultiGEN technology provides: Simultaneous detection of multiple pathogens or multiple SNPs in a single test on a single sample. Reports with verfiable accuracy based on modified ‘Gold Standard' Sanger Sequencing. Overall cost-effectiveness. MultiGEN Diagnostic Inc is a private biotechnology company incorporated in 2006 in California. Our business involves: Commissioning custom designed High-Throughput Test Modules (HTMs) that allow clinical laboratories to provide testing services using the MultiGEN platform. Developing custom designed MultiGEN based multiplexed assays. Providing testing services for drug development. Management T. V.Moorthy M.Sc., Ph.D., President, Founder The Company was founded in 2006 by Dr. Moorthy. Dr. Moorthy is a scientist with 35 years of experience in molecular biology. He holds numerous patents in a variety of fields covering three other platform technologies unrelated to MultiGEN. He received his training in Molecular biology from University of Uppsala, Sweden and the University of Alberta, Canada. He previously held the position of Head of the Department of Biochemistry, University of Jaffna, Sri Lanka. Some of his research includes identification of new trimethoprim resistance gene, cloning of glycogen de-branching enzyme, molecular characterization of the first melanoma associated human structural gene - Calnexin and novel hybridoma technology. He has more than 50 research publications and has been awarded five international fellowships. Dr. Moorthy is the principal intellectual force behind the development of MultiGEN technology, and has managed biotech companies for more than 15 years. He has been President Elect of the Rotary club of Jaffna, Sri Lanka, member of the University Senate and Chairman sports advisory committee (University of Jaffna Sri Lanka), member of the President's Council, University of Alberta, Adjunct Professor Department of Medicine, University of Saskatchewan Saskatoon and Visiting Professor Central Michigan University, Michigan. Dr. Roger Hodkinson MA MB.BChir, FRCP(C) Director, Clinical Affairs Dr. Hodkinson is a Pathologist by training and Director of Clinical Affairs of MultiGEN Diagnostics Inc. He was previously the CEO of Stirrat Laboratories, a large retail-oriented diagnostic medical laboratory in Alberta, Canada. Dr. Hodkinson is a Past President of the Alberta Society of Laboratory Physicians (ASLP), which represents pathologists in Alberta, Canada and has acted as a laboratory accreditation inspector. He is a co-author of a number of articles based on MultiGEN technology and holds medical degrees from Cambridge University in the United Kingdom. Marketing and Sales The Company will enter into a Marketing and Sales agreement with Select Laboratories. which is led by Ernest A Knesel as CEO and his team of team of executives, all with significant experience in the commercial clinical laboratory and diagnostic product segments of major healthcare business. Knesel was a founder and a senior executive of Roche Biomedical Laboratories which today is Laboratory Corporation of America (Labcorp). He was also a founder and President of Roche Image Analysis Systems and Autocyte which today is Tripath Imaging-BD. Manufacturing The Company is in discussion with Infrared Lab Systems of Indiana for the manufacturing of reagent components to suppot its technology. Infrared Lab System is an ISO 13485 manufacturer of diagnostic reagents and it is a FDA registered facility. Clinical Services MultiGEN has a unique patented approach to multiplexing assays. We can offer the basic multiplex technology and our expertise to companies engaged in practical and efficient test development. We provide services in four areas: a. Commissioning High Throughput Modules There is an increased medical desire to have comprehensive and accurate results, thus testing multiple analytes is becoming a necessity. At the same time, third party reimbursements are getting below 50% Medicare rates. Taking into account the increasing cost centers (e.g.labor) of present testing methods, MultiGEN's High Throughput Module (HTM) will reduce the testing cost per analyte and increase the dollar value of reimbursement per sample. The HTM consists of off-the-shelf equipment to process large volumes of samples using 96 and/or 384 plates. The HTM can be custom designed to; Detect multiple nucleic acid analytes per well/sample Generate nucleotide sequence based results for detection and confirmation. Process 200-10,000 samples per day. Process different test panels on the same test plate. Detect potential sample contamination during testing process. Nucleotide based barcording to trace sample source. b. Companion Diagnosis Following the FDA guidance on personalized medicine, there is an increasing need to have tests that will predict the treatment out come of specific drug on an individual basis. High expectation of sensitivity and specificity of the tests together with the availability of limited sample volume is becoming a challgene to present testing methods. MultiGEN's Allele Specific Multiplex Sequencing (ASMS) generates somatic mutation specific verifiable results without wild type suppression at the same time acheiving a Limit of Dectection (LOD) significantly below present assays. We have the capabilitites to develop the most accurate and companion diagnostic assays in oncology and viral infections. c. Drug Development MultiGEN is taking drug development to next level of predicting success. Our approach is based on pharmacophore based predictability. This involves analyzing expression profile of the target genes from the patient population to ensure drug/target interaction. Based on these analysis one could select the subjects on whom the drugs will have a greated chance for bring out desired pharmacological effect. d. Clinical Trials We offer custom designed testing services for clinical trials customers. MultiGEN based assays can test for single and/or multiple analytes from clinical materials. The analytes can be pathogens, cancer markers, single nucleotide polymorphism(SNP) or any combination. Assay development will be carried out at our facility in San Diego and the clinical validation and sample processing will be carried out through our CLIA approved clinical laboratory.