The clinical area of liquid biopsy for circulating solid tumor DNA is moving rapidly, and the Medicare MolDX program has two current guidance documents (as of 9/28/2016).
LBx Technical Performance Specs, Ver 2, Dated 5/24/2016
The first is Version 2 of its guidance document for analytical validity of circulating tumor DNA. This is available here (M00135, V2, Analytical Performance Specifications for Qualitative Tumor-only Somatic Variant Detections Using Circulating Tumor DNA). This is a detailed five page performance specifications document, released in May 2016 as Version 2. As written, it requires both CLIA certification "and" NY State certification, "and" fulfillment of the extensive MolDX test performance standards provided. However, the Q&A document with a later issue date (8/8/2016) states that the NYS requirement has been or will be rescinded.
LBx Q&A, Dated 8/8/2016
The second important guidance is a Q&A on MolDX's approach to Circulating Tumor DNA. This is an online webpage, released in August 2016, available here. This document notes that FDA approved tests (e.g. the Roche cobas EGFR ctDNA test) are expected to meet MolDX technical criteria.
In the versions available online as of 9/28/2016, both documents in a zip file in the cloud, here.
MolDx notes in the Q&A, that while it currently provides technical guidance, it has not yet issued an LCD (coverage criteria) for liquid biopsy tests in solid tumors.
