; or (II) meets the requirements to perform tests of high-complexity within the same corporate organization and having common ownership by the same parent corporation as the laboratory in which such test protocol was developed; or (ii) is an in vitro clinical test developed to diagnose a unique pathology or physical condition of a specific patient or patients (including an in vitro clinical test modified for such purpose), upon the prescription or order of a health care practitioner licensed to prescribe or order such test, or a health care professional or other specially qualified person designated under regulations to prescribe or order such test, for which no other in vitro clinical test is commercially available in the United States, and is— (I) not intended for use with respect to more than 5 (or such other higher number determined by the Secretary) other patients; and (II) not included in any test menu or template test report or other promotional materials, and is not otherwise advertised; and (B) the developer of the in vitro clinical test— (i) maintains documentation demonstrating that such test meets the applicable criteria described in subparagraph (A); (ii) makes such documentation, such as a prescription order requesting the custom test for an individual patient, available to the Secretary upon request; and (iii) informs the Secretary, on an annual basis, in a manner prescribed by the Secretary by guidance, that such test was offered. (5) In vitro clinical tests under a technology certification order An in vitro clinical test that is within the scope of a technology certification order under section 587D is exempt from premarket review under section 587B. (6) Modified tests (A) In general An in vitro clinical test that is modified is exempt from premarket review under section 587B if— (i) the modification is made by— (I) the developer that obtained premarket approval for the unmodified version of the test under section 587B