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.

On October 14, 2021, LUCID Diagnostics had an IPO raising $70M, trading on Nasdaq.  Lucid makes the "EsoGuard Esophageal DNA Test" and "EsoCheck" collection device.   EsoGuard DNA Test is an LDT.  A detailed S-1 financial plan is here.  I've clipped a few paragraphs from S-1 as a "Footnote."

On October 18, 2021, Castle Bioscience acquires Cernostics ("Barrett TissueCypher") for $80M.

The meeting was originally posted at least as early as September 10; I note on September 27 the webpage says "Updated September 27" but it's unclear what the update is.


Footnote - From LUCID S-1, IPO prospectus

We are a commercial-stage medical diagnostics technology company focused on the millions of patients with gastroesophageal reflux disease (GERD), also known as chronic heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma (EAC).

We believe that our lead products, the EsoGuard® Esophageal DNA Test performed on samples collected with the EsoCheck® Esophageal Cell Collection Device, constitute the first and only commercially available diagnostic test capable of serving as a widespread screening tool to prevent EAC deaths, through early detection of esophageal precancer in at-risk GERD patients. The technologies were highlighted in the NCI’s Annual Plan and Budget Proposal for FY2020 to Congress as one of the year’s significant advances in cancer prevention. We believe EsoGuard could have as great an impact in preventing EAC deaths as widespread Pap test screening has had in preventing cervical cancer deaths.

We were formed in May 2018 as a subsidiary of our parent company, PAVmed Inc. (Nasdaq: PAVM), to license the technologies underlying EsoGuard and EsoCheck from Case Western Reserve University (CWRU). [....]

In just over three years since our inception, we have advanced the technologies underlying EsoGuard and EsoCheck from the academic research laboratory to commercial products within scalable business model. EsoGuard is commercialized in the U.S. as a Laboratory Developed Test (LDT) and was granted final Medicare payment determination of $1,938.01, effective January 1, 2021. EsoCheck is commercialized in the U.S. as a 510(k)-cleared esophageal cell collection device. EsoGuard, used with EsoCheck, was granted FDA Breakthrough Device designation and is the subject of two large, actively enrolling, international multicenter PMA clinical trials.

We are proceeding with this offering and transitioning to a public company to drive a growth strategy focused on expanding commercialization across multiple channels, including expanding the number of our own testing centers, and expanding the clinical evidence of our products’ efficacy to support our ongoing regulatory, reimbursement and commercial efforts, as well as recommendation of our products in clinical practice guidelines.