UPDATE - MONDAY - DECEMBER 18 2018
FDA HAS POSTED APPROVAL PDF's ON FMI CDX
* Original Blog December 14 *
On November 30, 2017, CMS released a wide-ranging National Coverage Determination on next generation sequencing in all Medicare cancer patients, with comment period to
The pivot point of the NCD is the newly approved FDA PMA Foundation Medicine CDx test, FDA PMA P170019.
Confusingly, as of December 14, 2017, the FDA hasn't released any of its PMA safety effectiveness and validation review for the F1 CDx test.
See the product's FDA webpage here. These webpages appear first as a placeholder with product name and approval date and high-level label (indication). Thereafter, multiple FDA lengthy review documents are linked on this same page, as well as supplemental PMA documents (sPMA's). (For a mature FDA webpage, see the ThermoFisher Oncomine Target Dx Test, PMA P160045, here).
Lack of FDA documentation means only publications on the LDT era FMI CDx test are available. These LDT tests are non covered under the newly proposed NCD (except in NCI trials.) This makes it hard to comment on the NCD proposal.