Medicare cover is often driven by positioning in NCCN guidelines. On that score, a win on December 4, 2024, for Veracyte and its DECIPHER prostate recurrence risk test.
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Medicare has covered prostate risk tests from Decipher, Myriad, and Genomic Health for a number of years. At one point, they were near parity in Part B (based on annual, public claims data). In the last couple years, in Part B, usage of the Decipher test has pulled ahead of the other two tests. (Veracyte acquired Decipher in March 2021).
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- Dec. 5, 2024-- Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that its market-leading Decipher Prostate Genomic Classifier is the only gene expression test to be included in version 1 of the 2025 NCCN* Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as part of the updated “Advanced Tools” table located in the Principles of Risk Stratification and Biomarkers section (PROS-H) .
- “The Decipher Prostate test’s performance and clinical utility have been demonstrated in many dozens of peer-reviewed, published studies, including analyses of samples from multiple prospective, Phase 3 clinical trials, making it the most validated test of its kind for prostate cancer,” said Phil Febbo, M.D., Veracyte’s chief scientific officer and chief medical officer. “We believe the Decipher Prostate test’s unique status in the NCCN guidelines stems from the evidence generated through our commitment to research and our numerous collaborations with leading prostate cancer researchers around the world.”
- The Decipher Prostate test is a whole-transcriptome-derived, 22-gene signature that clinicians use to help assess the likelihood of a prostate tumor progressing to metastatic disease. Armed with this information, the clinician may recommend less-intensive or earlier, more-intensive treatment for the patient.
- “The Decipher Prostate test is already the most widely used molecular test in prostate cancer. We believe its unique status in the updated NCCN guidelines will help make it more accessible to even more patients,” said Marc Stapley, Veracyte’s chief executive officer.
A Wall St report here. Genomeweb here. On Yahoo Finance 12/6, Myriad is listed as down 11%, Veracute as up 3%. (Both changes are in the neighborhood of $100M of market cap, Veracyte's market cap being roughly 3x ($3B vs $1B).
Where to Find It
Find the 223-page December 2024 NCCN Prostate Guideline (branded v1.2025) here:
Email registration required.
On page 62, Advanced Tools, lists Decipher gene expression test and Artera-AI slide imaging test for "Localized" prostate risk uses. Only Decipher (aka 22 gene GC) is listed for "post-RP, post-radical-prostatectomy" risk.On the next page, Table 2 discussed Decipher in more detail. On the next page after that, Table 3 discusses Artera AI in more detail.
Below, click to enlarge.
Nerd Corner
Above are the 1.2025 version, just released. Online at Pubmed I found Schaeffer et al., April 2024, Version 3.2024 (PMID 38626801). This gave a different format, with more tests listed, of which only Decipher and Artera have Level 1 (1B) evidence in column 6. Decipher and Artera survive in the update to 1.2025. Here is 3.2024, click to enlarge.
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See posting on same topic by ARTERA - here.
