FDA approval of a medical test means that data on the test’s effects have been reviewed by the agency, and the test is determined to provide benefits that outweigh its known and potential risks for the intended population.
The approval process takes place within a structured framework that includes:
FDA Class 2 diagnostic tests (comprehensive metabolic panel, lipid panel, full urinalysis, blood glucose, hemoglobin A1C, heart rate, blood pressure, oxygen saturation), as well as FDA Class 3 tests, including MRI, CT, ECG, EEG, EMG and for diagnosing such diseases such as HIV and hepatitis B. All tests require approval by national or international governing bodies, such as the FDA in the United States and CE in Europe. Because the Zeptronic Diagnostics System is cloud based, releasing a newly approved test is a function of making it available to specific localities. Similarly, as new disease conditions or novel pathogens appear these too can be qualified and quantified with additional coding.
Eligibility for testing is dependent upon the FDA approvals, and the Company hopes Class 2 tests may take a year, while class 3 tests would take around two years of approval. The Company hopes SARS-CoV-2 testing approval will be quicker as the FDA views it as exigent circumstances being truly exception to the rule. This statement is ONLY true for corona virus testing given the pandemic. Exigent circumstances have not been established or implemented for any other testing.