SCC 2025 Coverage
Q: Assume no SCC coverage in 2025?
A: Management confirmed that the test remains covered by Medicare, and for prudence they are excluding SCC revenue from guidance post–October 1, leaving options for reconsideration or CMS appeals if needed.

Reconsideration Timeline
Q: What is the LCD/appeal timing?
A: They explained that once a new LCD is finalized there’s a 45-day lag for system updates, while the full reconsideration process could extend up to a year or two, reflecting uncertainty in timing.

Synergy & M&A
Q: How do test synergies affect growth and M&A?
A: Management highlighted robust cash balances and strong synergy between SCC and melanoma tests, supporting ongoing organic growth and reducing near‐term reliance on M&A.

MolDX Response
Q: How will you address MolDX noncoverage?
A: They noted that despite the noncoverage decision, they remain covered by Medicare and intend to engage with Palmetto to emphasize the test’s unique clinical benefits.

ART Studies
Q: Any further ART studies planned?
A: Management is actively planning additional studies to replicate and confirm the adjuvant radiation therapy benefits of the SCC test later this year.

EBITDA Outlook
Q: What about ongoing EBITDA growth?
A: While acknowledging a strong EBITDA beat this quarter, management expects the continued leverage of revenues over expenses to maintain healthy margins, though specifics were not detailed.

SCC Guidance Detail
Q: How’s the SCC test reflected in guidance?
A: They clarified that the uplift from DecisionDx-SCC is fully anticipated to impact the fourth quarter figures.

Guide Raise & ASPs
Q: Does SCC inclusion affect ASPs or raise guidance?
A: Management stated that the updated guidance excludes SCC contributions in Q4 and that no changes to ASP are expected.

TissueCypher Growth
Q: What’s driving TissueCypher’s growth?
A: An expanded sales team and recent training initiatives are fueling TissueCypher’s momentum, with sequential gains expected by early to mid–Q4.

AGA Guidelines Timing
Q: When for the AGA update?
A: They expect the forthcoming Barrett’s esophagus guidelines to arrive in about a couple of quarters, with ongoing efforts to ensure stakeholder awareness.

Novitas Engagement
Q: Updates on Novitas interactions?
A: Management mentioned limited engagement with Novitas so far, noting that the timeline remains unpredictable due to the opaque nature of CMS updates.

Commercial Coverage Approach
Q: How are commercial payers being addressed?
A: They described a conventional process where commercial payer decisions, often managed through lab benefit managers, naturally lag behind the accumulation of clinical evidence.

Marketing Strategy Shift
Q: Any shift in marketing focus for growth?
A: There is consideration to reallocate some SCC marketing spend toward boosting melanoma test penetration, though the current field force is viewed as appropriately sized.

IDgenetix Profile
Q: Who is adopting IDgenetix tests?
A: The test is resonating with psychiatrists, primary care physicians, and long-term care providers managing complex medication interactions.

Revenue Risk from Novitas Review
Q: Is there retrospective revenue risk?
A: Management reassured investors that since Novitas reviewed and confirmed coverage back in early 2022, there is no expected clawback risk to SCC revenue.