DNA Diagnostic Solutions For Clinical Applications
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MultiGEN Diagnostics


MultiGEN has a unique patented approach to multiplexing assays. We offer multiplexed sequencing technology, and our expertise, to companies wishing to outsource practical and efficient test development. We provide services in four areas:

 a. Commissioning High Throughput Modules

As there is an increasing medical need for comprehensive and accurate results, testing for multiple analytes is becoming a necessity. At the same time, third party reimbursements  are becoming less than 50% of Medicare rates. Taking into account increasing cost centers (e.g.labor) of present testing methods, MultiGEN’s High Throughput Module (HTM) reduces the testing cost per analyte, and increases the dollar value of reimbursement per sample. An 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.
  • Offer nucleotide-based barcording to trace sample source. Read More

b. Companion Diagnostics

Following the FDA guidance on personalized medicine, there is an increasing need to have tests that predict treatment outcome of specific drugs on an individual basis. The high expectation of sensitivity and specificity of the tests, together with the availability of limited sample volume, is becoming a challenge for present testing methods. MultiGEN’s Allele Specific Multiplex Sequencing (ASMS) generates verifiable and specific somatic mutation results without wild type suppression, while at the same time acheiving a Limit of Dectection (LOD) significantly below present assays. We have the capabilitites to develop the most accurate companion diagnostic assays in oncology and viral infections.

c. Drug Development

MultiGEN is taking drug development to the next level by predicting successful outcomes. Our approach is based on pharmacophore based predictability. This involves analyzing the expression profile of the target genes from the patient population to ensure drug/target interaction. Based on these analyses one is able to select subjects for whom the drugs will have a greater chance for creating the desired pharmacological effect. Read More

d. Clinical Trials

We offer custom designed testing services for clinical trial customers. MultiGEN-based assays can test for single and/or multiple analytes from clinical materials. The analytes can be pathogens, cancer markers, single nucleotide polymorphisms (SNPs) or any combination. Assay development is 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.