Natera Inc Stock Price, News & Analysis

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.

Natera (NASDAQ: NTRA) has announced its upcoming participation at the 2025 AACR Annual Meeting in Chicago, where data from 8 studies will be presented. The presentations will showcase research utilizing Natera's proprietary real-world database and Signatera™ testing.

Key highlights include:

• An oral presentation on large-scale genomic profiling of colorectal cancer, analyzing mutational landscapes across clinical and molecular subgroups using data from over 73,000 patients
• Poster presentations examining genomic patterns in 30,000+ breast cancer patients and 8,000+ gynecologic cancer patients
• Research on improving immunotherapy response prediction through enhanced neoantigen identification
• Additional studies on esophageal cancer, sarcoma, and colorectal cancer validating Signatera's clinical effectiveness

Natera (NASDAQ: NTRA) announced upcoming presentation of results from the DEFINE-HT study at the International Society for Heart and Lung Transplantation (ISHLT) 45th Annual Meeting on April 29, 2025. The study is the first prospective, multicenter trial evaluating the association between donor-derived cell-free DNA (dd-cfDNA) and clinical outcomes in heart transplant recipients using Prospera Heart with Donor Quantity Score (DQS).

The trial included over 1,100 dd-cfDNA tests, comparing Prospera testing with traditional rejection surveillance monitoring and endomyocardial biopsies for up to one year post-transplant. The research aims to determine if Prospera outperforms biopsy in predicting graft dysfunction and whether its proprietary two-threshold algorithm shows stronger correlation with clinical outcomes than dd-cfDNA percentage alone.

Natera (NASDAQ: NTRA) has initiated the HEROES clinical trial, enrolling its first patients to study the potential discontinuation of anti-HER2 targeted therapy in metastatic HER2+ breast cancer patients. The phase II trial, supported by the French Ministry of Health and sponsored by Unicancer, will involve approximately 170 patients across 35 French sites.

The study focuses on patients with HER2+ breast cancer, which affects 15-20% of breast tumors. Using Natera's Signatera™ testing, the trial will monitor patients who discontinue anti-HER2 maintenance therapy, with the primary endpoint being 1-year progression-free survival in Signatera-negative patients.

Key protocol elements include baseline testing of patients who have been on standard-of-care anti-HER2 therapy for two or more years. Signatera-negative patients will stop treatment and undergo regular monitoring, while Signatera-positive patients will continue maintenance therapy. Treatment will resume if radiological progression is confirmed or if a patient becomes Signatera-positive.

Natera (NASDAQ: NTRA) has secured a new patent (No. 12,203,142) from the U.S. Patent and Trademark Office, strengthening its intellectual property portfolio in tumor-informed molecular residual disease (MRD) testing. The patent specifically covers methods for testing single nucleotide variants in circulating-tumor DNA (ctDNA) using whole exome and whole genome sequencing.

The patent details various target enrichment techniques in plasma, including multiplex polymerase chain reaction PCR and capture by hybridization. This addition expands Natera's extensive intellectual property estate, which now includes over 110 patents in cell-free DNA analysis for oncology testing, with 23 patents obtained in 2024 alone.

Natera (NASDAQ: NTRA) reported strong financial results for Q4 and full year 2024. The company achieved total revenues of $476.1M in Q4 2024, up 53.0% from Q4 2023, with product revenues growing 53.9%. Full-year 2024 revenues reached $1.70B, a 56.7% increase from 2023.

Q4 2024 highlights include improved gross margin of 62.9% (vs 51.4% in Q4 2023), processing of 792,800 tests (26.5% increase), and positive cash flow of $45.7M. Notably, oncology tests grew 54.7% to 150,800 in Q4. The company's net loss decreased to $53.8M in Q4 2024 ($0.41 per share) from $78.0M in Q4 2023.

For 2025, Natera projects revenue between $1.87B-$1.95B, with expected gross margins of 60-64%. The company held $968.3M in cash and investments as of December 31, 2024.

Natera (NASDAQ: NTRA) announced that its Signatera test has received Medicare coverage for patients with non-small cell lung cancer (NSCLC) in the surveillance setting. This coverage applies to stage I-III NSCLC patients with resectable or unresectable disease, expanding upon existing Medicare coverage for immunotherapy monitoring.

Lung cancer is the leading cause of cancer death in the U.S., representing about 1 in 5 cancer deaths. By 2025, it's projected to have 226,650 new cases and 124,730 deaths. Despite treatment advances, the 5-year survival rate remains low at 28%.

Current surveillance tools have limitations including sensitivity issues and interpretation difficulties with CT scans. Signatera's performance for NSCLC surveillance was validated in three peer-reviewed studies showing 93-100% sensitivity to extracranial recurrence, 96-100% specificity, and detection up to one year before imaging (median: 5 months).

Signatera is also Medicare-covered for monitoring in colorectal, bladder, breast, and ovarian cancers.

Natera (NASDAQ: NTRA), a leading provider of cell-free DNA and genetic testing services, has announced its upcoming fourth quarter and full year 2024 financial results release. The company will disclose its results after market close on February 27, 2025, followed by a conference call and webcast at 1:30 p.m. PT (4:30 p.m. ET).

Interested parties can access the conference call through domestic (1-888-770-7321) or international (1-929-201-7101) dial-in numbers using Conference ID 7684785. A webcast will be available at the provided link, with a replay accessible later at investor.natera.com.