Comprehensive Molecular Genetic Testing for Laboratory Medicine

Amendment: 0001 Questions and Responses 1) Is this specifically for oncology? No testing is not specifically for oncology 2) Is there an expected yearly volume by category? No estimated volume by category can be provided. The total estimated number of tests is around 200 annually. 3) Are these research-use only cases or intended to also be made available for clinical care? If a mix, can you provide anticipated research vs. clinical volume? These genetic testing results will be made available in the patients medical record and all NIH providers taking care of the patient will have access to them. There is no way to predict how the results will be used by various NIH providers once they are located in the patients permanent medical record, unless the vendor indicates that a specific test result is not validated for clinical care. In that case, the providers would only be able to use it for research purposes. 4) For germline sequencing validated or RUO? Respondent should indicate whether their germline sequencing is validated or RUO.