By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence
In keeping with Medicare’s expanded coverage of HIV screenings aimed at achieving earlier detection of the virus (see National Intelligence Report, Feb. 12, 2015), the CDC is also focusing on earlier and more efficient detection of HIV. It is looking to collaborate with “companies that have developed a simplified nucleic acid test that can detect acute or established HIV-1 infection.” The reason? The CDC says current testing involves delays, and earlier detection can lead to more prompt initial treatment and better monitoring of identified cases.
The announcement distinguishes acute HIV infection as the “early infection period associated with high viral load that occurs before the development of HIV antibodies” as opposed to established HIV infection which arises after the HIV antibodies are already detectable. The goal of the collaboration is to determine how well simplified nucleic acid tests perform. “Only tests that are near production (i.e. , not first generation prototypes) will be eligible for the collaboration,” according to the CDC’s notice in the Feb. 11, 2015 Federal Register.
The collaboration is predicted to last between one and six years and is phased – with the first phase testing “well characterized stored or mock laboratory specimens” and a subsequent phase using a subset of high performing tests and “prospectively collected specimens.”
Potential collaborators must “be planning to produce a simplified nucleic acid test for distribution in the United States and to seek FDA approval for diagnostic or prognostic use (priority given to tests with both applications).”
Applications are due by April 13, 2015 and should address:
- Availability of data about the tests’ performance,
- Testing technology and how it detects HIV RNA and/or DNA,
- Length of time to perform the test, specimen on which its performed (whole blood, serum, plasma, dried blood spots) and how its performed on each type of specimen,
- Test storage and stability, and
- Manufacturer’s intentions regarding CLIA waiver and HHS/FDA approval, including whether seeking “a diagnostic claim, a prognostic claim (for patient monitoring) or both.”
CDC may show preference to manufacturers of rapid nucleic acid tests and to tests requiring 60 minutes or less, potentially qualifying as moderate complexity or CLIA-waived, and “capable of both qualitative and quantitative applications.” While the collaborators are expected to provide the tests, protocols and access to data concerning the tests, the CDC anticipates its role to be providing specimens, conducting the tests and interpreting results, running research studies and publishing results of those studies and otherwise providing its scientific expertise.
For more information see the CDC’s notice in the Feb. 11, 2015 Federal Register (pages 7606-7607).