Natera Posts Record Signatera Volumes and Raises Guidance by $100 Million as Regulatory Approvals Stack Up Across Three Continents
Q2 2026 earnings call, August 6, 2026
Natera delivered what CEO Steve Chapman called "an exceptional quarter," processing more than 1 million tests for the second consecutive period and posting the largest sequential jump in Signatera volumes in company history. The molecular diagnostics company raised its full-year revenue guidance by $100 million at the midpoint to a range of $2.85 billion to $2.91 billion, implying 31% growth ex true-ups, as a wave of regulatory approvals in the U.S., Japan, and Europe began converting into commercial momentum.
Signatera Volume Growth Breaks Records Again
Clinical MRD units grew 34,000 sequentially in the quarter, easily surpassing what CFO Mike Brophy noted was the company's previous all-time high of roughly 25,000 units set just one quarter earlier when Signatera itself was up 20,000 sequentially for the first time. Total clinical MRD volume reached 283,000 units, up approximately 56% year-over-year. Management was careful to temper expectations for a repeat performance, noting that Q1 volumes had been artificially suppressed by weather, which exaggerated the quarter-over-quarter comparison. Still, Chapman said July was "off to a very good start" and guided investors to expect growth "somewhere right in the middle" between the 25,000 and 34,000 unit range going forward, rather than a full retracement.
The acceleration reflects a confluence of factors two years in the making. Natera made a significant investment in the size of its commercial team in 2025, and those hires are now "hitting their stride," according to Chapman. Layered on top of that is what he described as a halo effect from the FDA's approval of Signatera as a companion diagnostic in bladder cancer, along with broad-based adoption gains across both new accounts and existing patient starts. "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," Chapman said, adding that Natera believes it is the "major beneficiary of that" given its scale advantage in data, sales force, and clinical evidence versus emerging competitors.
A Trio of Regulatory Firsts Reshapes the Competitive Landscape
The quarter delivered an unusually dense cluster of regulatory milestones. In May, the FDA approved Signatera as a companion diagnostic for muscle-invasive bladder cancer, backed by the Phase III IMvigor011 trial, an industry first for MRD testing that Chief Medical Officer Alexey Aleshin called validation of "the whole treat-on-MRD concept at the highest level." In June, Japan's PMDA approved Signatera for colorectal cancer, supported by the GALAXY study, with commercial launch expected later this year pending pricing and reimbursement. In July, Signatera received IVDR certification in the EU, making it the first MRD test for solid tumors to clear that bar across more than 20 tumor types, a designation that both streamlines biopharma trial collaborations in Europe and positions Natera for future reimbursement ahead of the 2028 IVDD transition deadline.
Natera is now pushing further into Japan with a new PMDA submission for Signatera as a companion diagnostic in bladder cancer, working alongside Chugai, which markets atezolizumab in the country. Solomon Moshkevich, President of Clinical Diagnostics, said the roughly 34,000 annual new bladder cancer cases in Japan, of which 20% to 25% are muscle-invasive, represent "a compelling second indication" and pointed to the more than 20 Japanese clinical sites that participated in IMvigor011 as evidence that local oncologists are already familiar with the testing protocol.
NCCN Category 1 Status Becomes a Payer Catalyst
The NCCN Guideline Committee issued a Category 1 recommendation, its highest designation, for Signatera-guided adjuvant treatment in muscle-invasive bladder cancer, the third such guideline endorsement for Natera's tumor-informed MRD approach following prior recommendations in Merkel cell carcinoma and diffuse large B-cell lymphoma. Moshkevich explained that the guideline language specifically calls for "a personalized tumor-informed multiplex PCR-NGS assay," phrasing he said "uniquely describes Signatera." Management said the guideline update is already driving new commercial payer coverage policies well beyond what biomarker legislation alone could achieve, since some plans have blanket coverage triggers for NCCN-recommended or FDA-approved companion diagnostics.
ASP Trajectory Toward $2,000 Gains Credibility
Signatera's average selling price rose to roughly $1,275, up $25 sequentially, continuing a steady climb the company attributes to improved reimbursement consistency across Medicare Advantage and commercial plans in biomarker states. Management reiterated its long-standing target of a mature ASP around $2,000 per test, with Brophy telling analysts he feels "better about the long-term vision for getting to $2,000... than I really ever have since we launched Signatera 6, 7, 8 years ago." The company disclosed that its seven pending MolDX coverage submissions across additional tumor indications could be worth an incremental $150 to $200 to ASP once fully rolled out, a process management expects to play out over the next 12 to 18 months rather than the current fiscal year. Guidance for 2026 assumes flat ASPs, meaning any coverage wins would represent unmodeled upside pushed into 2027.
Interventional Trial Program Targets Practice-Changing Data
Natera disclosed a new phase of its clinical strategy with the launch of SIGNAL-ER 101, its first fully self-sponsored and self-operated interventional study. The trial targets a provocative question in early-stage HR-positive, HER2-negative breast cancer, the most common breast cancer subtype, where Aleshin said "the vast majority of patients today may be overtreated" with CDK4/6 inhibitors that carry more than 60% serious adverse event rates and a retail cost exceeding $400,000 per course. The study will escalate treatment only when Signatera detects molecular residual disease, sparing MRD-negative patients from therapy they may not need. Aleshin described the trial's ambition bluntly: it is not randomized because the ctDNA-negative arm is expected to perform so well that "we're actually looking for performance... to do so well that really what we're doing is almost comparing to close to 100%." Management said this is the first of a broader SIGNAL program spanning multiple major tumor histologies, with additional studies launching in coming months, each designed to pharma-grade standards with the explicit goal of changing standard of care.
Underpinning this push is what Aleshin characterized as a seven-year investment cycle now entering its payoff phase. Natera has opened more than 70 prospective studies since 2019, and management expects the pace of readouts to "accelerate meaningfully over the next few years," each a potential trigger for new guidelines, reimbursement, and volume.
Organ Health Gets a Bigger Medicare Runway
The final Medicare Local Coverage Determination for organ transplant surveillance, published in July, expanded meaningfully beyond the original CMS proposal following advocacy from transplant medical societies. Medicare will now cover six tests in year one for kidney transplant patients and twelve for heart and lung transplant patients, with four tests annually in years two and three across all three categories. The policy takes effect August 30, and management expects it to lift both Prospera volumes and ASP in the back half of the year as providers update surveillance protocols.
Women's Health Share Gains Tied to Product Overhaul
Women's health revenue grew at a high single-digit rate on a seasonally adjusted basis, outperforming what is typically the company's softest quarter. The gain was driven by the newly enhanced Panorama test, which Moshkevich said solves a persistent industry problem: reliable performance at low fetal fraction, the point at which detecting chromosomal abnormalities becomes far more difficult and where some prior technologies have shown trisomy 21 sensitivity as low as 62%. The new version reduced Natera's no-call rate to 0.5%, an 80% improvement, based on prospective blinded data across more than 3,300 patients including 240 low fetal fraction cases, with 100% detection of trisomy 21 in that cohort. Management characterized the launch as unlocking a segment of OB/GYNs who wanted SNP-based testing but had been deterred by no-call rates. Chapman also pointed to direct share gains as a rival flagged softness in its own women's health business.
Margins and Spending Discipline
Gross margin held at approximately 65%, with a roughly 50 basis point sequential improvement ex true-ups offset by higher costs from ramping newer, not-yet-optimized products including Fetal Focus, LATITUDE, and Signatera Genome. Management continues to target 70%-plus gross margin over time, characterizing the path as a mix of gradual improvement and step-function gains tied to major coverage decisions. The company is spending approximately $100 million this year on its early cancer detection program, including the FIND trial, which currently generates no revenue or margin benefit; management said this spending will taper once the program scales. Natera's average days sales outstanding improved to 57 days, down four days sequentially, and the company continued to generate positive operating cash flow while narrowing per-share losses.
On competitive dynamics, Chapman was direct that emerging MRD entrants have not dented growth, noting Natera's overall market penetration remains in the "mid-single digits," leaving a large runway regardless of new entrants. "It's such a large market, it really doesn't have a significant impact on us," he said, while adding that the company is "keenly watching" competitor moves and will invest to close any perceived gaps.