Natera Inc Stock Price, News & Analysis

Natera (NASDAQ: NTRA) has launched the TEODOR trial, a Phase II randomized controlled trial studying the use of Signatera™ in early-stage breast cancer treatment. The trial aims to identify hormone receptor-positive (HR+), HER2-negative breast cancer patients who could safely avoid chemotherapy before surgery.

The study, sponsored by the Austrian Breast & Colorectal Cancer Study Group (ABCSG), will enroll approximately 250 patients across 15 Austrian sites. Patients who test Signatera-negative and show favorable endocrine sensitivity will be randomized to receive either endocrine therapy or chemotherapy. The trial's primary endpoint focuses on neoadjuvant therapy response, with secondary endpoints including breast cancer recurrence and overall survival.

Natera (NASDAQ: NTRA) announced the publication of its PEDAL study results in the American Journal of Transplantation, demonstrating the prognostic capabilities of its Prospera™ kidney transplant monitoring test. The study, involving 488 kidney transplant recipients across 28 centers, focused on donor-derived cell-free DNA (dd-cfDNA) trends following rejection.

The groundbreaking results showed that patients with low/decreasing Prospera trends had 60x higher odds of positive outcomes after one year and were 13x more likely to have resolving kidney dysfunction. Notably, 97.5% of cases with sustained elevated Prospera trends experienced negative clinical outcomes, highlighting the test's effectiveness in post-rejection risk assessment.

Natera (NASDAQ: NTRA) presented significant clinical data for its tissue-free Latitude™ MRD assay at ESMO GI 2025. The study, part of CIRCULATE-Japan's GALAXY arm, analyzed ~200 patients with over 1,300 plasma samples in resectable stage I-IV colorectal cancer.

Key findings showed excellent clinical performance with 58% sensitivity in post-surgical MRD detection and 81% in surveillance, alongside high specificity (92% patient-level, 97% sample-level). The assay demonstrated strong prognostic value for recurrence risk and effectively predicted adjuvant chemotherapy benefit in high-risk stage II and III patients.

Natera (NASDAQ: NTRA) announced it will present new clinical data for its Signatera™ monitoring technology at the 2025 ESMO GI Congress in Barcelona. The presentations will showcase significant findings across colorectal cancer (CRC) applications.

Key findings include data from over 3,000 CRC patients showing Signatera ctDNA-positive patients were up to 20x more likely to receive curative-intent metastasis-directed therapy compared to Signatera-negative patients. The MD Anderson INTERCEPT study (n=31) demonstrated 100% specificity/PPV and high surveillance sensitivity in rectal cancer patients.

A budget impact model from BUPA insurance revealed a projected 43% reduction in healthcare costs using Signatera-guided adjuvant treatment versus standard care in stage II-III CRC. The company will present six studies at the congress, including validation data on its tissue-free MRD assay and methylation-based biomarkers for colorectal cancer.

Natera (NASDAQ: NTRA) has secured Medicare coverage for its genome-based Signatera MRD assay under LCD L38779. The coverage extends to Medicare beneficiaries with colorectal, breast, bladder, ovarian, and lung cancers, as well as pan-cancer immunotherapy monitoring. The decision was backed by extensive validation from over 100 published clinical studies. At the 2025 ASCO Annual Meeting, Natera presented a pan-cancer study involving 392 patients and over 2,600 samples using Signatera Genome. The assay utilizes Natera's patented multiplex PCR-NGS technology for deep sequencing of targeted high-quality variants, and has been launched for both research and clinical applications.

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.