Natera NTRA announced that its molecular residual disease (MRD) test, Signatera, received certification as a Class C device under the European Union’s In Vitro Diagnostic Regulation (IVDR) for use across multiple types of cancer. Signatera is certified to be used in adjuvant and surveillance settings across a broad range of cancers, including gastrointestinal, genitourinary, breast, skin, gynecological, head and neck, non-small cell lung cancer, and diffuse large B-cell lymphoma, indolent non-Hodgkin's lymphomas and pan-cancer immunotherapy monitoring.
The certification makes Signatera the first personalized MRD test for solid tumors to achieve IVDR certification in the European Union.
Per management, achieving the IVDR certification reaches a milestone in Natera's strategy to expand Signatera MRD testing across Europe. Supported by extensive clinical evidence across multiple cancer types, the certification builds on the company's recent regulatory successes in the United States and Japan.
Likely Trend of NTRA Stock Following the News
Following the announcement, Natera’s shares gained 2.7% at yesterday’s closing. Year to date, the NTRA stock has risen 23% against the industry’s 0.1% decline. The S&P 500 has returned 10.3% in the same timeframe.
The IVDR certification is likely to strengthen investor sentiment by supporting Signatera’s commercial expansion across European markets. The approval reduces regulatory hurdles for future clinical trial launches and allows Natera to continue offering the test beyond the European Union’s IVDD transition deadline in 2028. As adoption of MRD-diagnosed cancer management continues to grow, the latest certification may further enhance Natera’s competitive position in the evolving precision oncology diagnostics market.
NTRA currently has a market capitalization of $39.30 billion.
Image Source: Zacks Investment Research
More on the News
The IVDR certification is regarded as one of the world's most stringent regulatory frameworks for in vitro diagnostic medical devices. The certification covers the entire Signatera platform, including the assay, specimen collection kit and associated software, following a comprehensive review of its analytical validity, clinical performance and quality management systems.
The latest achievement builds on Natera’s two major regulatory achievements for Signatera in recent months. In June 2026, Signatera received approval from Japan’s Pharmaceuticals and Medical Devices Agency for colorectal cancer patients, while in May 2026, the FDA approved Signatera CDx as a companion diagnostic for patients with muscle-invasive bladder cancer. Together, these milestones strengthen Natera’s global presence and position the company to drive broader adoption of personalized MRD testing across international markets.
Industry Prospects Favoring the Market
Going by the data provided by Precedence Research, the minimal residual disease testing market was valued at $1.70 billion in 2025 and is expected to witness a CAGR of 12% through 2034.
Factors such as the demand for highly sensitive technologies like next-generation sequencing and digital PCR, which accurately detect minimal residual cancer cells to guide treatment decisions and predict patient outcomes, are boosting the market’s growth.
Other News
Natera recently partnered with Aveta Biomics to support AVTA 30-01, a global Phase 3 registrational trial of its oral immunotherapy, APG-157, in patients with locally advanced head and neck squamous cell carcinoma. Natera’s Signatera test will be integrated into the AVTA 30-01 Phase 3 study to assess MRD and treatment response during neoadjuvant, induction, adjuvant and follow-up care.
Natera partnered with Eledon Pharmaceuticals to integrate its Prospera kidney transplant assessment test into Eledon’s planned Phase 3 clinical trial of tegoprubart, an investigational therapy designed to prevent organ rejection in kidney transplantation.
Natera announced a collaboration with CytoDyn to evaluate ctDNA dynamics and generate real-world molecular data in support of the latter’s metastatic colorectal cancer program.
Natera, Inc. Price
Natera, Inc. price | Natera, Inc. Quote
NTRA’s Zacks Rank & Key Picks
Natera currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the broader medical space are Veracyte VCYT, West Pharmaceutical WST and Pacific Biosciences of California PACB.
Veracyte, currently sporting a Zacks Rank #1 (Strong Buy), reported first-quarter 2026 adjusted earnings of 52 cents per share, which beat the Zacks Consensus Estimate by 52.9%. Revenues of $139.1 million surpassed the Zacks Consensus Estimate by 6.6%. You can see the complete list of today’s Zacks #1 Rankstocks here.
Veracyte has an estimated earnings growth rate of 5.1% for 2026. VCYT’s earnings surpassed estimates in the trailing four quarters, the average surprise being 45.9%.
West Pharmaceutical, currently carrying a Zacks Rank #2 (Buy), reported first-quarter 2026 earnings per share of $2.13, which beat the Zacks Consensus Estimate by 26.8%. Revenues of $844.9 million surpassed the Zacks Consensus Estimate by 8.5%.
West Pharmaceutical has an estimated long-term earnings growth rate of 13.9%. WST’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.4%.
Pacific Biosciences, carrying a Zacks Rank #2 at present, reported a first-quarter 2026 adjusted loss per share of 12 cents, which was narrower than the Zacks Consensus Estimate by 29.4%. Revenues of $37.2 million missed the Zacks Consensus Estimate by 9.3%.
Pacific Biosciences has an estimated earnings growth rate of 22.6% for 2026. PACB’s earnings surpassed estimates in the trailing four quarters, the average surprise being 29.8%.
Zacks' Research Chief Names "Stock Most Likely to Double"
Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.
This top pick is a little-known satellite-based communications firm. Space is projected to become a trillion dollar industry, and this company's customer base is growing fast. Analysts have forecasted a major revenue breakout in 2025. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Hims & Hers Health, which shot up +209%.
Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Natera, Inc. (NTRA): Free Stock Analysis Report
West Pharmaceutical Services, Inc. (WST): Free Stock Analysis Report
Pacific Biosciences of California, Inc. (PACB): Free Stock Analysis Report
Veracyte, Inc. (VCYT): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).