New DNA-barcode Patent Virtually Eliminates False Test Results and Sample Mix-up

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Bio-ID Diagnostics Inc., the parent company of MultiGEN Diagnostics Inc., has been awarded a US patent for broad based QC/QA applications in clinical diagnostic testing. This can eliminate false negatives and provide novel features for sample tracking.

The patent provides substantially greater confidence in the reporting of molecular diagnostic test results. It also enables true sample ID and superior tracking capabilities necessary for the validation and reporting of high profile assays such as those used in oncology. Molecular diagnostics is a rapidly growing area of biotechnology that includes DNA based tests for infectious disease, genetic predisposition, cancer, and companion diagnostics in personalized medicine. The new patent overcomes two major challenges faced by all molecular diagnostic tests: firstly, confirmation that the critical steps of any one test really are performing as intended, and secondly, ruling out the possibility of false positive results caused by cross-contamination.

Confirmation of the core question “is the test working right?” is best addressed with a built-in positive internal DNA control tested with every sample. The positive internal control and the sample are thereby subjected to identical test conditions, and a sample result can be rejected if the presence of the internal control is not confirmed. This unique capability is expected to significantly improve the quality of molecular diagnostics in modern clinical medicine.

Irrespective of the platform technology used, all molecular diagnostic assays have two steps: an amplification step (PCR) and an identification step. "Unfortunately, present molecular tests only provide good control for the amplification step, not the identification step” said the inventor, Dr. T. V. Moorthy. “MultiGEN’s true internal control provides excellent quality control for both of these critical steps” he added. He further noted that “the new patent thereby virtually eliminates the potential for false negative results in molecular diagnostics.”

The patent also allows for a unique DNA-based barcode to be included in the testing of each sample. The barcode specifies the gender, sample type, customer (hospital/referring physician), collection time, specific tests and clinical diagnosis. This important new ID control detects any false positive results caused by cross-contamination, and also enables confident sample tracking. “Although this feature will be a component of all MultiGEN based assays, we expect it will be used independently as an effective component for system validations in other areas of clinical diagnostics including clinical chemistry, liquid based cytology, and LC-MS systems,” said Dr. Roger Hodkinson, Chairman of Bio-ID Diagnostic Inc. “Consequently,” he added, “sample mix-ups will shortly become a thing of the past”. “But more importantly,” he noted, “in a generic sense, this new patent addresses the critical question of ‘what’s in the tube?’, as opposed to the current ‘who’s on the label?’, and promises to transform current regulatory requirements for QA and QC.”

For further information please contact Dr. T. V. Moorthy at moorthy(at)multigen-diagnostics(dot)com.

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