'Bar Code' Diagnostic Method Analyzes DNA Structure, Not Sequence
Scientists are saving time and money in the laboratory thanks to a novel approach to identifying genetic variations that was transformed into a practical tool with support from NIST’s Advanced Technology Program (ATP). The technique also is expected to reduce healthcare costs by improving the precision of medical diagnosis and treatment—saving patients the money, time, and pain often wasted on ineffective therapies. The technique was developed by Third Wave Technologies, Inc., a small biotechnology company in Wisconsin. Known as CFLP®, the new approach identifies mutations and other variations that affect physical structure of DNA, making it an alternative to conventional methods based on chemical sequence. When analyzed with the new method, each different piece of DNA produces a unique “fingerprint” that looks like a bar code (similar to those on supermarket products). The ATP funding enabled the company to expand on its early observations of the proprietary bacterial enzymes involved in the process, design a process that is practical and reliable, develop reagents, and conduct extensive testing. The first product kit based on ATP-funded research was commercialized by Third Wave for the research market in mid-1996 and brought about $300,000 in sales that year. A variety of clinical applications have been validated by scientific studies, including one by Italian scientists who concluded that CFLP scans longer DNA fragments and detects mutations faster than conventional methods. When used to identify different strains of the hepatitis C virus (a factor in resistance to interferon therapy), CFLP costs much less than two standard competing methods (including automated DNA sequencing), according to tests performed by ClinCyte, a contract research organization in California. ClinCyte now plans to use CFLP in clinical trials of new drugs for hepatitis C and tuberculosis. The ATP funding helped Third Wave develop several new enzymes, attract additional funding from the National Institutes of Health and Department of Energy, acquire 20 patents, and grow from 6 to 72 employees. Third Wave also has formed alliances with five major distributors in four product markets. In addition, the company recently received a second ATP award to develop generic, enzyme-based technologies suitable for healthcare applications, such as large-scale treatment monitoring and point-of-care testing. ATP funding: $1,998,000 November 1998
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