Natera Inc Stock Price, News & Analysis

Natera announced impressive clinical performance results for its Signatera Genome assay at ASCO 2025, demonstrating exceptional accuracy in cancer detection and monitoring. The large-scale study involving 392 patients across five cancer types showed 94% sensitivity and 100% specificity. The assay detected cancer recurrence 3 months earlier than its predecessor and demonstrated ultrasensitive detection capabilities, with 50% of positive cases detected at ≤100 parts per million. Notably, patients with negative Signatera results showed excellent prognosis with 99% distant relapse-free survival at 24 months, while positive results indicated higher recurrence risk. The study also revealed that Signatera-positive patients who received adjuvant therapy showed significantly better outcomes (83% vs 49% 12-month survival) compared to untreated patients.

Natera announced it will present data from over 25 Signatera™ studies at the 2025 ASCO Annual Meeting, covering nearly 25,000 patients across multiple cancer types. Key highlights include:

The DARE clinical trial interim analysis of 507 breast cancer patients showed 99% of Signatera-negative patients remained recurrence-free after 27.4 months. The trial demonstrated 2x higher ctDNA clearance rates in the treatment arm.

A real-world study of over 600 metastatic breast cancer patients revealed Signatera ctDNA dynamics were the strongest predictor of treatment benefit. The Signatera Genome assay study analyzed over 3,000 samples from 300+ patients across 5 major cancer types.

The presentations include 6 oral presentations and multiple poster sessions, covering breast cancer, melanoma, gastrointestinal, genitourinary cancers, and other indications, demonstrating Signatera's clinical utility in cancer monitoring and molecular residual disease assessment.

Natera (NASDAQ: NTRA) reported strong Q1 2025 financial results with total revenues of $501.8 million, up 36.5% year-over-year. The company achieved significant growth across key metrics: product revenues increased 37.1% to $500.0 million, gross margin improved to 63.1% from 56.7%, and processed 855,100 tests, a 16.2% increase. Notably, oncology tests grew 46.1% to 167,700. The company generated positive cash flow of $23.2 million. Despite higher operating expenses of $395.9 million, Natera reported a reduced net loss of $66.9 million ($0.50 per share). The company maintains a strong financial position with $991.6 million in cash and investments. For 2025, Natera projects total revenue between $1.94-$2.02 billion with positive net cash inflow.

Natera (NASDAQ: NTRA) will present multiple datasets at the 2025 ESMO Breast Cancer Annual Congress in Munich, showcasing results from the I-SPY 2 clinical trial. The study of 712 early-stage, high-risk breast cancer patients revealed that Signatera-positive patients had 3x higher recurrence risk compared to Signatera-negative patients. Key findings show that higher ctDNA quantities at diagnosis correlated with increased recurrence risk, and Signatera status emerged as the most significant predictor of distant recurrence free survival (DRFS). The research marks the first demonstration of pre-treatment absolute ctDNA quantity correlating with clinical outcomes in breast cancer. Natera will present six abstracts total, including real-world evidence from their database of over 200,000 cancer patients.

Natera (NASDAQ: NTRA) has published a new study in the American Journal of Transplantation demonstrating superior performance of its Prospera Heart test with DQS in detecting transplant rejection. The study analyzed 808 test samples from 187 heart transplant patients and showed significant improvements over traditional dd-cfDNA percentage testing, including: - Sensitivity increased to 86.5% (from 78.2%) - Specificity improved to 83.6% (from 76.9%) - 37.3% reduction in false positives - Area under curve (AUC) increased to 0.881 (from 0.865) The Prospera with DQS method combines donor fraction and donor quantity score to deliver a single result for assessing both antibody mediated rejection (AMR) and acute cellular rejection (ACR). This advancement could help reduce the need for invasive endomyocardial biopsies in heart transplant patients.

Natera (NASDAQ: NTRA) announced results from a Stanford-led study evaluating its Signatera molecular residual disease (MRD) test in sarcoma patients. The study, the largest of its kind, analyzed over 2,100 samples from 200+ sarcoma patients, demonstrating outstanding performance with 89% overall sensitivity and 100% specificity. For leiomyosarcoma, the most common subtype studied, the test showed 93% sensitivity and 100% specificity, with 90% correlation to treatment response.

The study's significance lies in addressing the challenges of monitoring sarcomas, which comprise over 70 distinct subtypes affecting approximately 17,000 new cases annually in the US. The research validates Signatera's effectiveness in noninvasively detecting disease recurrence and monitoring treatment response across various sarcoma subtypes. The team plans to launch a prospective study to further demonstrate clinical utility.

Natera (NASDAQ: NTRA), a leading company in cell-free DNA and genetic testing, has scheduled its first quarter 2025 earnings release for May 8, 2025, after market close. The company will host a conference call and webcast at 1:30 p.m. PT (4:30 p.m. ET) on the same day. Investors can access the conference call through domestic (1-888-596-4144) or international (1-646-968-2525) dial-in numbers using conference ID 7684785. A webcast replay will be available at investor.natera.com.

Natera has announced significant results from its DEFINE-HT clinical trial in heart transplantation, presented at the International Society for Heart and Lung Transplantation Annual Meeting. The study evaluated their Prospera Heart test with donor quantity score (DQS) in monitoring heart transplant outcomes.

Key findings from the trial, which analyzed over 1,100 donor-derived cell-free DNA (dd-cfDNA) samples, showed:

• Patients with elevated dd-cfDNA levels had 2.56 times higher risk of adverse events
• The test predicted graft dysfunction 3 times more effectively than traditional biopsy
• Prospera with DQS showed stronger correlation with clinical outcomes versus donor fraction alone

The study positions Prospera as a potential alternative to invasive endomyocardial biopsies (EMB), with ongoing research through the ACES-EMB study comparing both methods. This advancement represents a significant step toward less invasive transplant monitoring approaches.

Natera (NASDAQ: NTRA) has announced the broad clinical launch of its ultra-sensitive Signatera Genome MRD test for physicians across the United States. The launch is backed by extensive validation data from over 3,000 plasma samples across multiple cancer types, including breast, colorectal, non-small cell lung cancer, melanoma, and renal cell carcinoma.

The study, to be presented at the 2025 ASCO Annual Meeting, demonstrates Signatera Genome's ability to detect circulating tumor DNA (ctDNA) ahead of clinical recurrence. Patients testing Signatera-positive after surgery showed inferior recurrence-free survival compared to Signatera-negative patients across all cancer types studied.

The test utilizes Natera's patented multiplex PCR and next-generation sequencing technology, capable of detecting tumor DNA at frequencies as low as 1 part per million, with an RUO version detecting below this threshold.