This test has been developed and its performance characteristics determined by Genova Diagnostics, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration.
Commentary is provided to the practitioner for educational purposesk, and should not be interprteted as diagnostic or treatment recommendations. Diagnosis and treatment decisions are the responsibility of the practitioner.
The accuracy of genetic testing is not 100%. Results of genetic tests should be taken in the context of clinical representation and familial risk. The prevalence and significcance of some allelic variations may be population specific.
Any positive findings in your patient's test indicate genetic predisposition that could affect physiologic function and risk of disease. We do not measure every possible geneetic variation. Your patient may have additional risk that is not measured by this test. Negative findings do not iumply that your patient is risk-free,
The Third Wave(tm) Invader DNA assay is used to dewtect polymorphisms in the patient's DNA sample. In this assay, a solution hybridization method is used in which two oligonucleotides hybridize in tandem with the specific DNA seqauences. Subsequent Cleavase(r) and hybridization reactions result in generation of fluyorescent signal. The biplex format of the assay enables simultaneous detection of all variants in a single reaction tube. The sensitivity and specificity of this assay is < 100%.
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