Regarding the clinical evidence engine (Slide 13), are there specific readouts to highlight, and is the SIGNAL-ER 101 study considered practice-changing?

Management emphasized the increasing pace of prospective readouts, which are designed to be impactful for guidelines and reimbursement. They confirmed SIGNAL-ER 101 is designed to be practice-changing, aiming to identify patients in HR+/HER2- breast cancer who truly need CDK4/6 inhibitors, potentially sparing others from toxic and expensive therapy. This is the first of a broader interventional SIGNAL program. “If the study is positive, we do believe that this study will be practice changing. And that's the mentality we've taken with every single SIGNAL study that we have designed and plan to initiate in the next few months.”

Given the sequential ASP increase and upcoming catalysts like MolDX, NCCN, and biomarker states, could Signatera ASPs accelerate beyond the recent $25 sequential increase?

Management stated the current guidance assumes stable ASPs at $1,275 for the rest of the year. An upside case might see another $25 sequential increase, driven by tactical improvements like Medicare Advantage compliance and biomarker state expansion. However, larger, transformational ASP increases (e.g., $150-$200 from MolDX expansion) are expected in 2027, as these wins take time to translate into revenue recognition. “I mean, I'd estimate that's worth something like $150 to the ASP, perhaps $200. So Daniel, I think your estimate is roughly in the right range. So obviously, that's a transformational difference when you start at $1,275 and you add that.”

With other MRD competitors gaining traction, is Natera seeing any impact, or is there enough market for everyone? How does Natera maintain its lead?

Management acknowledged ongoing competition but stated it hasn't significantly impacted Natera, which has consistently performed well. They attribute their success to continuous investment in technology, robust clinical studies, focus on user experience, and a strong commercial team. They believe the market is very large and early in penetration, offering ample upside for Natera, while actively monitoring competitors. “I mean we're still very early in penetration in the overall market. I would sort of say mid-single digits. So we think there's a lot of upside here, and we're really in the best position to capture that upside.”

NTRA

Natera (NTRA) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

Executive summary

Natera Q2 FY26 — Record Test Volumes & Raised Revenue Guidance

Natera delivered a record-breaking quarter, driven by strong test volumes across all business segments and significant oncology milestones including FDA and PMDA approvals for Signatera. The company raised its full-year revenue guidance, reflecting robust commercial execution and ASP improvements, while continuing strategic investments in R&D for future growth initiatives like early cancer detection.

Highlights

Processed approximately 1,044,000 tests in Q2 FY26, setting a new company record.
Oncology clinical MRD units grew 56% year-over-year to 283,000 units in Q2 FY26.
Generated approximately $753 million in revenue in Q2 FY26, representing 38% growth year-over-year (40% ex true-ups).
Raised full-year 2026 revenue guidance midpoint by $100 million to $2.85 billion-$2.91 billion.
Achieved strong gross margins of approximately 65% in Q2 FY26, with sequential improvement.

Concerns

Q1 FY26 weather-related events suppressed MRD volumes by several thousand units, exaggerating Q2 sequential growth.
COGS increased slightly in Q2 FY26 due to an uptick in volumes from recently launched products like Fetal Focus, LATITUDE, and Signatera Genome.
Approximately $100 million is being spent in FY26 on development work and the FIND ECD trial, which does not yet yield top-line or margin benefits.

Guidance & targets

Category	Target	Timeline	Confidence
Full-year 2026 Revenue	$2.85 billion to $2.91 billion high materiality	FY26	High
Full-year 2026 Revenue Growth (ex true-ups)	31% high materiality	FY26	High
Full-year 2026 Operating Expenses (OpEx)	Held steady medium materiality	FY26	High
Full-year 2026 Gross Margin	Held steady medium materiality	FY26	High
Long-term Signatera ASP	around $2,000 high materiality	Long-term	High
Long-term Gross Margin	70% plus high materiality	Long-term	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Women's Health Results were particularly strong on a seasonally adjusted basis, counteracting typical Q2 seasonality with strong new account wins driven by Fetal Focus adoption and the enhanced Panorama test launch.	—	high single-digit growth	—	—

NTRA operating KPIs by quarter

NTRA operating KPIs stated on its earnings calls, by fiscal quarter
KPI	Dec 2024 Q4 FY24	Mar 2025 Q1 FY25	Jun 2025 Q2 FY25	Sep 2025 Q3 FY25	Dec 2025 Q4 FY25	Mar 2026 Q1 FY26	This call Jun 2026 Q2 FY26	Change vs prior quarter
Average selling price Signatera	~$1,100 Signatera clinical ASPs improved to roughly $1,100 in Q4, and we continue to see steady progress for both Panorama and Horizon ASPs. Source: earnings call transcript	$1,100+ Signatera ASPs moved above $1,100 in the quarter, driven primarily by continued execution on securing Medicare Advantage reimbursement. Source: earnings call transcript	—	~$1,200 Women's health and organ health each had another standout quarter and Signatera ASPs are now at roughly $1,200. Source: earnings call transcript	~$1,225 Signatera ASPs stepped up to roughly $1,225 in Q4. Source: earnings call transcript	~$1,250 Unit ASPs were up across the board in women's health in Oregon Health and Signatera ASPs reached another high now at roughly $1,250. Source: earnings call transcript	~$1,275 Signatera ASPs were up to roughly $1,275 as we continue to drive more consistent reimbursement for Medicare Advantage and commercial plans in biomarker states. Source: earnings call transcript	—
Procedures	—	855K We had an outstanding volume quarter across the board with 855,000 units processed in the quarter. Source: earnings call transcript	—	—	~924K We processed about 924,000 tests and set another record for MRD clinical unit growth with 225,000 tests processed in Q4. Source: earnings call transcript	1M Q1 was our first to deliver 1 million units in a single quarter headlined by excellent volume performance in women's health and another record growth quarter for oncology. Source: earnings call transcript	~1.044M We processed approximately 1,044,000 tests in the second quarter, once again exceeding 1 million units and setting a new company record with strong volume performance across the business. Source: earnings call transcript	—
Procedures Oncology	—	—	189K We processed 189,000 oncology tests in the quarter, which represents nearly 20,000 units of growth compared to our first quarter of this year. Source: earnings call transcript	—	—	249K In oncology, we processed 249,000 clinical oncology units in the quarter, which is 55% growth over last year and yet another record with roughly 24,000 units over the Q4 results. Source: earnings call transcript	283K In oncology, we processed 283,000 clinical MRD units, representing year-over-year growth of approximately 56% compared to Q2 of 2025. Source: earnings call transcript	+13.7%

Operating figures the company stated on at least two of the calls shown, checked against each call's transcript. Click a figure to read the sentence. A dash means it was not stated that quarter.

Product announcements

Product	Type	Timeline
Enhanced Panorama test	launch	May 2026
Fetal Focus	launch	2025
Fetal RhD test	launch	2024

Deals & partnerships

Chugai Collaboration for Signatera PMDA submission in bladder cancer

Natera is advancing in lockstep with Chugai, who markets atezolizumab in Japan, for the PMDA submission of Signatera as a companion diagnostic in bladder cancer.

Risks & headwinds

Exaggerated Q2 sequential volume growth due to Q1 weather impact Q1 FY26 impact on Q2 FY26 comparison

Q1 MRD volumes suppressed by several thousand units

Mitigation:Management acknowledges the artificial boost and guides for a more linear growth model for forecasting Signatera units.

Increased COGS from new product launches Near-term

COGS increased slightly in Q2

Mitigation:Management expects to achieve COGS improvements over time as volumes scale and through optimization projects, aiming for 70%+ gross margin long-term.

Significant R&D investment in early cancer detection without immediate returns FY26

~$100 million in FY26

Mitigation:Management views this as a strategic investment in a huge future market opportunity, expecting scaling benefits once launched and millions of tests per year.

What to watch in Q3 FY26

Signatera volume growth pace

Next quarter (Q3 FY26)

Current 34,000 sequential units (Q2 FY26)

Target Sustained strong sequential growth, outperforming previous record of 25,000 units

Why it matters

To assess if the exceptional Q2 growth was an anomaly or if the momentum from sales force productivity and regulatory approvals can drive continued strong performance.

But I wouldn't say necessarily we're going to repeat that immediately. But if you look at, I think our previous record was maybe 25,000 quarter-over-quarter or something like that. And I think we can outperform that as we move forward. And Q3 is off to a very good start.

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Q&A highlights

What are the principal drivers behind the strong Signatera volume growth, and how sustainable is this quarter-over-quarter growth, especially looking into 2027?

Management attributed growth to the halo effect of FDA approval, significant investments in commercial and medical affairs teams, and large-scale clinical trials. They expect continued strong performance, though not necessarily repeating the record 34,000 sequential unit growth immediately, aiming to outperform the previous record of 25,000. They believe the market is reaching a tipping point where doctors increasingly adopt MRD testing.

“I think we're crossing the sort of tipping point in the field where doctors are really starting to believe in MRD as a core part of their practice.”

asked by Puneet Souda · answered by Steve Chapman

2 min read 5 chapters

Detailed narrative

Oncology Milestones and Regulatory Successes

Natera achieved several crucial oncology milestones for Signatera, including its U.S. FDA approval as a companion diagnostic for muscle-invasive bladder cancer, making it the first MRD test to receive such approval. It also secured Japanese PMDA approval for colorectal cancer and IVDR certification in the EU for over 20 tumor types, streamlining future clinical trials and setting up for future reimbursement in Europe.

The NCCN Guideline Committee issued a Category 1 recommendation for Signatera-guided adjuvant treatment in muscle-invasive bladder cancer, expected to drive adoption and positive commercial payer coverage policies.

Women's Health Product Innovation

The company launched its enhanced Panorama test, powered by novel SNP-informed deep sequencing technology, which significantly reduces the no-call rate to 0.5% (an 80% improvement) and demonstrates 100% detection of trisomy 21 in low fetal fraction patients. This enhancement, along with the successful Fetal Focus (single-gene NIPT) and Fetal RhD tests, has led to strong new account wins and positions Natera competitively in women's health.

Organ Health Medicare Coverage Expansion

The final Medicare LCD for organ transplant surveillance was published in July, representing a meaningful expansion of coverage for Prospera. Medicare will now cover 6 tests for kidney transplant patients and 12 tests for heart and lung transplant patients in year 1 post-surgery, and 4 tests per year across all three categories in years 2 and 3.

This policy, effective August 30, is expected to drive improvements in Prospera ASP and volumes.

Clinical Evidence Engine and SIGNAL Program

Natera has built a robust clinical evidence engine for Signatera, initiating over 70 prospective studies since 2019. These studies are now beginning to read out, with the pace expected to accelerate, providing catalysts for guidelines, reimbursement, and volume. The company introduced SIGNAL-ER 101, its first Natera-sponsored interventional prospective study in HR+/HER2- breast cancer, aiming to use Signatera to identify patients who truly need CDK4/6 inhibitors, potentially changing practice and reducing overtreatment.

Early Cancer Detection (ECD) Progress

The pivotal FIND study for early cancer detection is approaching full enrollment, with approximately 24,000 average risk adults enrolled to date and completion expected in Q3 FY26. The company plans to read out the FIND cohort in 2027, with ongoing productive conversations with the FDA. Natera remains enthusiastic about developing a differentiated product with high sensitivity for advanced adenomas.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.