Wednesday, May 22, 2024

MolDx X 3: Proteomics Calendar; Breast Cancer Expert Meeting; Results of Recent Public Comments

Tracking "What's New" on the MolDx website...

  • Proteomics Under MolDx

For several years, 2021-2024, MolDx staff did not regulate proteomic tests.  (Think of it like FDA not regulating LDTs.)   However, some labs were caught in a game of keepaway between whether they could be assessed for coverage by MolDx or by Noridian.  Basically, this was like being in a corridor with an exit door on either end, one marked "Noridian" and one marked "MolDx," and both of them locked.

At the beginning of 2024, MolDx published a list - "Article A59636" - describing what proteomic tests would fall under its jurisdiction.   This is "good news, bad news" - MolDx would consider the listed tests for coverage under new LCDs, but, MolDx might ensure the listed tests under its control weren't paid in the meantime, either.  

On May 17, 2024, MolDx published a notice that this enforcement is delayed until January 31, 2025.

Simple (single or double protein) proteomic tests remain outside of MolDx; check the code listing in A59636 for updates.  Info here.

  • MolDx Public Meeting: Breast Cancer DCIS Tests July 15, 2024

Don't make any plans for July 15, 2024, from 2-4 ET, because you'll probably want to be at your local sports bar with your gang, watching the live telecast of this MolDx Contractor Advisory Meeting.  The topic is, "Biomarker Risk Stratification Testing in DCIS."   

The format is typically expert presentations and then discussion.  Public questions aren't entertained.  After a few months, a transcript is posted.  Results may inform future LCDs. Info here.

  • Posted:  Transcript of Open Public Meeting, Thyroid Risk Stratification, Pulmonary Nodule Stratification, Prostate Cancer Stratification.

The meeting was October 9, 2023, and this was a public comment meeting.  Recordings and transcript are posted here.   Transcript 26pp.


AI Corner

Here's an AI-generated meeting report from October 9.

Meeting Report: 

MolDX Public Comment Meeting on Thyroid, Lung, and Prostate Cancer Management

Date: October 9, 2023
Duration: 1 hour, 1 minute, 57 seconds
Moderator: Dr. Angella Charnot-Katsikas

1. Prostate Cancer Management

  • Speaker: Dr. Ashley Ross, Associate Professor of Urology, Northwestern Feinberg School of Medicine
  • Topic: Gene expression profiling for metastatic prostate cancer, specifically the Decipher test by Variscite.
  • Highlights:
    • Emphasis on the increasing incidence of metastatic prostate cancer.
    • Detailed presentation on treatment options and their impacts based on the Decipher genomic classifier.
    • Demonstrated how genomic classifiers like Decipher can predict survival rates and guide treatment intensification decisions.
    • Noted that prostate cancer is a major health issue, being the most common non-skin cancer in American men.

2. Lung Nodule Risk Stratification

  • Speaker: Dr. Ehab Billatos, Assistant Professor of Medicine, Boston University
  • Topic: Molecular biomarkers for risk stratification of indeterminate pulmonary nodules post-bronchoscopy.
  • Highlights:
    • Discussion on the challenges of managing lung nodules identified during cancer screening.
    • Advocated for the use of molecular diagnostics prior to invasive procedures like bronchoscopy to better manage nodule risk.
    • Stressed the importance of advancing diagnosis through less invasive methods, potentially improving early detection and management.

3. Thyroid Nodule Risk Stratification

  • Speaker: Dr. Paul Ladenson, Johns Hopkins University School of Medicine
  • Topic: Molecular testing for risk stratification of thyroid nodules.
  • Highlights:
    • Discussed the prevalence of thyroid nodules and the importance of molecular testing to avoid unnecessary surgeries.
    • Highlighted the specific challenges and benefits of molecular testing in predicting malignancy and guiding surgical decisions.
    • Presented the need for reliable tests to improve the accuracy of cancer detection in thyroid nodule management.

4. General Observations and Concerns:

  • Technological Challenges: Several speakers experienced technical difficulties during their presentations, affecting the smooth flow of the meeting.
  • Policy Implications: There were calls for policy updates to accommodate the evolving landscape of molecular diagnostics, particularly to expand the use of pre-procedural biomarker testing in lung and thyroid nodule management.
  • Engagement: The meeting did not allow for a question-and-answer session, directing participants to submit written comments instead.

Conclusion: The meeting provided valuable insights into the current and potential uses of molecular diagnostics in managing thyroid and lung nodules, as well as metastatic prostate cancer. Speakers advocated for policy shifts to embrace less invasive diagnostic practices and highlighted the need for precise risk stratification tools in clinical settings. The discussions underscored the critical role of advanced molecular testing in improving patient outcomes through tailored treatment strategies. -- Chat GPT 4.



AI Corner 2

Sports Version

"Clash of Titans: Innovations Compete at the MolDx Arena"

Venue: MolDx Public Comment Meeting

In an electrifying display that could rival any sports championship, the MolDx Arena was ablaze with cutting-edge discussions on the frontiers of cancer diagnostics! On October 9, 2023, the stage was set  for a powerhouse lineup of scientific titans clashing over the latest in molecular diagnostics. The battleground? Thyroid, lung, and prostate cancer management, where each speaker brought their A-game, aiming for a knockout with every fact and figure.

Round 1: The Prostate Cancer Showdown

Champion: Dr. Ashley Ross, Northwestern's Maestro of Urology In the left corner, wearing the lab coat and armed with the Decipher test, Dr. Ross dove into the fight against metastatic prostate cancer. With the precision of a seasoned fighter, she laid out how gene expression profiling isn't just a tool—it's a weapon that's revolutionizing how we attack prostate cancer. She deftly explained how this approach helps pinpoint aggressive treatments for those in dire need while protecting others from the harsh side-effects of unnecessary therapy. Her data-packed punches highlighted a survival strategy that left the audience in awe.

Round 2: Lung Nodule Challenge

Contender: Dr. Ehab Billatos, Boston University’s Pulmonary Strategist - Switching gears to the lung nodule competion, Dr. Billatos entered with a flurry of stats and screens, focusing on the perilous world of indeterminate pulmonary nodules. As he navigated the court, through lung cancer screening and risk stratification, Dr. Billatos championed less invasive diagnostics that promise to be a knock-out punch for unnecessary bronchoscopies. His vision offered a glimpse into a future where lung cancer management is as strategic as a chess match.

Round 3: The Thyroid Tactical Battle

Veteran: Dr. Paul Ladenson from Johns Hopkins.  The crowd cheered for the main competition, with Dr. Ladenson stepping up to discuss the molecular testing tactics that could outmaneuver the risks of thyroid surgery. With the finesse of a veteran, he argued for the necessity of reliable molecular tests that can discern benign from malignant nodules, potentially saving thousands from the scalpel. His detailed review of molecular testing underscored a proactive defense strategy against thyroid cancer, emphasizing precision in diagnosis and treatment.

Post-Game Analysis

As the dust settled on this high-stakes event, it was clear that each speaker not only shared groundbreaking data but also painted a vision of a future where cancer might just meet its match. Like any top-tier sports event, the MolDx meeting left fans—er, participants—buzzing with excitement and anticipation for what's next in the playbook of cancer diagnostics. Dr. Charnot-Katsikas, moderating this epic showdown, wrapped up the proceedings with a nod to the relentless pursuit of medical innovation, a field where the goal isn't just to win, but to save lives.

The echo of the day’s discussions resonated like the cheers in a stadium: loud, hopeful, and a testament to the progress in the relentless battle against cancer. As the attendees filed out, the message was clear: in the fight against cancer, the power of molecular diagnostics is a game-changer and it's just getting started.  - Chat GPT 4