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Third Wave Technologies Inc. (TWTI) Enters Strategic Partnership with DCL Medical Laboratories; Receives Clearance from FDA for Cystic Fibrosis Screening Test

Third Wave Technologies Inc. (TWTI), headquartered in Madison, Wisconsin, develops and markets molecular diagnostic reagents for a variety of DNA and RNA analysis applications to meet the needs of customers. The company offers a number of products based on its Invader® chemistry for clinical testing. Third Wave offers in-vitro diagnostic kits, and analyte-specific, general purpose, and research-use only reagents for nucleic acid analysis.

The company received clearance from the US Food and Drug Administration for its InPlex™ CF Molecular Test. The test simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. Cystic fibrosis is a fatal disease that affects more than 30,000 Americans carrying a genetic mutation. Testing for cystic fibrosis provides critical information about a parent’s carrier status and also aids in the early diagnosis of newborns with the disease.

The InPlex™ CF Molecular Text delivers the accuracy of Third Wave’s Invader® chemistry in an easy-to use microfluidic card developed in collaboration with the 3M Company. The test is a genotyping test that provides information for cystic fibrosis carrier screening for adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing for the disease in newborns and children. In studies submitted to the FDA, the InPlex™ CF Molecular Test achieved 100-percent accuracy on cystic fibrosis-positive samples and 99.6-percent overall accuracy when compared to DNA sequencing, the standard for genotype determination.

The company also recently announced a strategic partnership with DCL Medical Laboratories LLC, a full-service reference laboratory focused on women’s health. DCL will serve as a product development, demonstration and marketing partner with Third Wave, and will adopt products from the company’s expanding molecular diagnostic menu. Under the terms of the partnership, it will also obtain early access to new assays and equipment developed by Third Wave. In return, Third Wave will establish a research and development laboratory for DCL to use in product research, which will include a customer demonstration facility for the company’s products.

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