Personal Genome Diagnostics (PGDx) got FDA clearance for its multi-hundred gene elio test in late April, 2020 - here. Styled as clearance K192063, under product code PZM and classification 21 CFR 866.6080 (NGS tumor profiling), the elio test can be run locally on a standard platform. (Product description clipped at bottom [*]).
- The 32-page FDA review is online here.
- The full 108 page 510K decision summary is also online at FDA here.
- The K192063 home page is here (check for updates).
- As an IVD, elio should have detailed FDA-authorized "instructions for use" - I haven't seen those yet. A copy is usually on the FDA website.
It's unclear exactly how MolDx will handle usage of the test from this point forward.
- Will elio be issued one Z code, that is "turned on" for any hospital client to use?
- Or will each hospital using elio have to get its own Z code?
- If the latter, with local hospital Z codes, will each hospital using elio have to show its on-site validation to MolDx for review?
- It's pretty clear coverage falls under the NGS solid tumor LCD, see A57831 here. So no review for "coverage" or "clinical utility" was involved.
- On the other hand, regarding edits, LCD L38045 has been active since February 2020, and in a August 2020 copy of the MolDx Master Edit File, a lot of solid tumor tests were not crosswalked to L38045 for editing (here).
It looks like the MolDx review of the elio IVD took some length of time between the April 24 FDA authorization and the September 9 press release.
Noting that, several stakeholders have asked me about the necessity of lengthy MolDx review of an FDA IVD for analytical accuracy (the coverage under L38045 was already in place and not under discussion). For example, CMS Coverage Group endorses and requires coverage of any and all FDA approved or cleared NGS companion diagnostic or any FDA approved or cleared NGS hereditary risk profiling test, two categories which are very similar in FDA review standards to the elio 108-page review released in April. If the clearance labeling for elio had been worded only a tiny bit differently, the test would have been auto-covered by the somatic and germline CMS NGS NCD without any MAC review of analytical validity of its NGS platform.
PGDx elio tissue complete, the first FDA-cleared comprehensive genomic profiling kit, is used to identify alterations in the tumor and inform treatment decisions for patients with advanced solid tumors. The kitted system allows molecular laboratories anywhere to perform this advanced genomic testing of cancer in a more efficient, standardized, and accurate manner. By providing tests that can be run locally and automating the data analysis process, PGDx is enabling the adoption of precision medicine in healthcare systems across the country, no matter where a patient seeks treatment.
PGDx elio™ tissue complete
PGDx elio™ tissue complete is an FDA-cleared diagnostic kit and accompanying software for molecular labs that provides comprehensive genomic profiles of all solid tumors. PGDx elio tissue complete detects single nucleotide variants (SNVs) and small insertions and deletions (indels) in 500+ genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI), and tumor mutation burden (TMB). Designed to be used locally at any laboratory across the country, PGDx elio testing and automated bioinformatics ensures both consistency and quality of results regardless of location.
Re uncertainly of single, or hospital-specific Z codes, I couldn't find any info yet at MolDx: