NEW YORK – Updated guidelines from the National Comprehensive Cancer Center issued this week have adjusted the way that certain molecular tests are described and categorized, including separating out Veracyte's Decipher test as the only assay of its type that meets the evidence criteria for listing as an "Advanced Tool."
Among other shifts, the update features changed language describing the use of somatic tumor testing. Rather than saying that tumor molecular and biomarker analysis "may be used," the guide now says that such testing "is recommended" for patients with metastatic disease to inform treatment decision-making. The same change has been made regarding testing for tumor mutational burden.
The document also now notes specifically that loss of BRCA1 and BRCA2 may be especially associated with response to PARP inhibitor therapy compared to other gene alterations that affect homologous recombination repair.
For early-stage prostate cancer, the guidelines continue to note the availability and potential value of three Medicare-reimbursed risk tests, Veracyte's Decipher, Myriad Genetics' Prolaris, and the Oncotype DX genomic prostate score, currently owned by MDx Health.
Only Decipher is listed in the guide's "Advanced Tools" table, based on its achievement of level I evidence using a rating system called the Simon evidentiary framework.
In the most recent prior version of the guidelines, Decipher was listed at evidence level IB, with the other two tests rated as level IIIC.
Despite the change in evidence ratings, the discussion section of the guide still endorses all three gene-expression tests for use in risk stratification, as long as they are ordered only when they have the potential to change patient management. The discussion section update is still in progress, so this could change with further refinement of the document.
As of right now, the guide still states that any of the three can be considered for patients with low or favorable intermediate disease and life expectancy greater than or equal to 10 years.
For patients with unfavorable intermediate- and high-risk disease and life expectancy greater than or equal to 10 years the guidelines recommend only Decipher or Prolaris.
And finally, Decipher can also be considered to inform adjuvant treatment if adverse features are found after radical prostatectomy or during workup for post-prostatectomy PSA persistence or recurrence.
The guidelines note that future comparative effectiveness studies could shift these considerations as the landscape of clinical utility evidence changes.
In a note to investors, equity research firm Wolfe Research said that while outcomes are uncertain, it views the update as a likely positive for Veracyte, with the potential to influence up to 40 percent market gain.
In Friday morning trade on the Nasdaq, Veracyte's shares were up about 6 percent at $45.47.