Friday, September 10, 2021

MolDx Posts Advisory Committee for Upper GI Cancer, October 12, 2021

MolDx has posted an announcement that it will hold a Contractor Advisory Committee on October 12, 2021 (2-4 ET, 11-2 PT).  Registration is open until October 11.  The conference is listen-only mode for the audience.

The meeting will discuss the clinical literature related to MolDX: Molecular Testing for Risk Stratification of Upper Gastrointestinal Cancer and rate their confidence in a series of key questions.

What they mean is, tests that risk-classify Barrett's Esophagus (dysplasia).  The key question is, "Is there sufficient data to use molecular testing to risk stratify patients with BE to low or high grade dysplasia?"  Historically, this was done by tiny biopsy samples and simply rating the tissue on H&E slide for dysplasia.

They also ask, does the test preclude the need for more invasive procedures?  And/or, can biomarkers be sampled by less invasive means than traditional endoscopic biopsy?

  • There's a recent open access review article by Grady et al., 2020, here.   
  • There's an open-access article on managing Barrett's by Kamboj , 2021, here.  (One author, Iyer, is also featured on the Cernostics web site here.)
  • There's a non-open-access review by Souza and Spechler, 2021, here.

The MolDx website is linked below, and the website includes additional documents like agenda and the complete text of key questions.  As well as registration.



I don't have a comprehensive roster of labs in this space but two with a focus on biomarkers in Barrett's would include Cernostics ("Tissue Cyper") and CDX ("WATS3D" testing).   Cernostics is backed by Pittsburgh/ UPMC (here).  

Unrelated to Barrett's, but also in the field of advanced pathology/immunohistochemistry, is ImmunoScore slide-based testing for colon cancer from HalioDx, recently acquired by Veracyte, in a circa $300M deal.  Their code 0X70U/0261U, was presented at the June 2021 CMS new test pricing meeting, with a request to crosswalk to 0108Ux1.2 (at $3015).   CMS will release pricing this fall.

For a July 2021 article by Liang et al. on digital pathology, here from the boutique consultancy Bionext.

The journal with the Grady review article mentioned above, published a long list of symposium articles on early detection of cancer with molecular testing in 2020 - here.  The articles spring from the 20 year NCI effort, Early Detection Research Network or NCI-EDRN. Overview of that, by Bast and Srivastava here.