MolDx Covers MRD Test for Head and Neck - Based on Circulating HPV DNA

MolDx has granted coverage under its "Minimal Residual Disease" LCD, for monitoring head and neck cancer.

There's a twist.  Most MRD tests are based on the return of, or disappearance of, circulating tumor DNA.   The NAVDX test from NAVERIS is based instead on detection of tumor-modified HPV DNA in the circulation.

See press release at Biospace:

https://www.biospace.com/article/releases/naveris-receives-medicare-coverage-for-navdx-test/

There's more detail in a subscription article at Genomeweb/Precision Medicine Online:

https://www.precisionmedicineonline.com/precision-oncology/naveris-optimistic-about-hpv-liquid-biopsy-test-uptake-after-medicare-coverage

I confirmed that NAVDX is listed as "covered" on the DEX registry run by Palmetto (app.dexzcodes.com). No price is listed, but the company has a not-yet-nationally-priced PLA code.

<UPDATE JAN 2024: TEST IS PRICED AROUND $900>

  Here's the DEX description. Note, it's based on droplet digital PCR.  

DEX 

Oncology (oropharyngeal), cell-free DNA, droplet digital PCR to profile the fragmentation pattern of tumor tissue modified viral (TTMV) HPV DNA using 17 DNA biomarkers, weighted fragment size distribution algorithmic analysis, whole blood, algorithm reported as a prognostic TTMV risk score for cancer recurrence. (NavDx(r), Naveris Inc.) The intended use of the test is for monitoring patients with previously diagnosed HPV-driven head and neck cancers for recurrent and or residual HPV-driven oropharyngeal cancer.

Clinical Studies - "WOW"

See the Clinical Studies page, with some two dozen listings.   Some are abstracts, but many are full articles.

https://naveris.com/clinical-publications/ 

Pricing Nerd Note

Code 0356U was just finalized as a 2024 gapfill code by CMS.  (Here) . The AMA PLA code text is, Oncology (oropharyngeal), evaluation of 17 DNA biomarkers using droplet digital PCR (ddPCR), cell-free DNA, algorithm reported as a prognostic risk score for cancer recurrence.

Since the code 0356U is "NOT" yet price on a national fee schedule, it must have a locally set price (until 1/1/2025) as a covered test.  So I'm surprised its price isn't on the DEX database page, which normally does list the price for all covered tests which are not paid on a fee schedule.

According to my notes from the summer lab pricing meetings at CMS, there was no presentation on 0356U in June at the public meeting, and the expert panel in July briefly noted the code and quickly recommended "gapfill."  

Geography

According to its press release, Naveris is based in Massachusetts and North Carolina.  The North Carolina entity may be, to take advantage of the MolDx system, and the press release specifies it got MOLDX coverage (North Carolina) not NGS MAC coverage (Mass.)  Data for 2022 shows that NGS MAC rarely pays for genomic tests unless they are FDA-approved tests covered by an NCD (here).

Funding

Naveris raised $51M in 2022, here.

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ddPCR - Other

Another commercial digital PCR test is Oncocyte's liquid biopsy kidney transplant test, here.

Not to be confused with... Head and Neck- Other
0356U (plasma, HPV, head and neck cancer recurrence) is not to be confused with 0296U, Viome, saliva, HPV, mRNA, also for head and neck cancer detection, $1755.