; and (2) is a test— (A) that represents a breakthrough technology; (B) for which no approved or precertified alternative exists; (C) that offers a clinically meaningful advantage over existing approved or precertified alternatives, including the potential, compared to existing approved or precertified alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies