EU and US could reach trade deal this weekend - Reuters
AUSTIN, Texas - Natera, Inc. (NASDAQ: NASDAQ:NTRA), a prominent player in the field of cell-free DNA and genetic testing with a market capitalization of nearly $21 billion, has recently secured expanded Medicare coverage for its Signatera test, aimed at patients with non-small cell lung cancer (NSCLC). The company has demonstrated remarkable growth, with revenue surging 55% in the last twelve months. InvestingPro analysis indicates the stock is currently trading above its Fair Value, reflecting strong investor confidence in its growth trajectory. The Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Services Program (MolDX) now covers the test for stage I-III NSCLC patients, both with resectable and unresectable disease, in a surveillance setting.
The decision by CMS to provide coverage for the Signatera test is a significant development for NSCLC patients and Natera’s business prospects. The company maintains a strong financial position, with a healthy current ratio of 4.39 and impressive gross profit margins of 57.66%. Lung cancer remains the deadliest form of cancer in the United States, with an estimated 226,650 new cases and 124,730 deaths in 2025. The average age at diagnosis is 70 years, and despite advances in treatment, the 5-year overall survival rate is a mere 28%. For detailed financial analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro.
The Signatera test has been validated through three independent peer-reviewed studies, demonstrating its efficacy in the surveillance setting for stage I-III NSCLC. These studies have shown the test to have a sensitivity range of 93-100% for detecting extracranial recurrence, with specificity between 96-100%, and the ability to identify recurrence up to one year ahead of imaging, with a median lead time of five months.
Dr. Alexey Aleshin, MD, Natera’s corporate chief medical officer and general manager of oncology, commented on the CMS coverage decision, noting the growing body of evidence supporting Signatera’s role in risk stratification, treatment response monitoring, and early detection of recurrence, which can inform treatment decisions across a wide range of cancer indications.
Signatera is a personalized test that uses circulating tumor DNA to detect and quantify residual cancer, thereby identifying recurrence earlier than standard care tools and helping optimize treatment decisions. It is available for clinical and research use and is now covered by Medicare for a variety of cancer indications, including colorectal, bladder, breast, and ovarian cancers.
Natera is known for its commitment to advancing personalized genetic testing and diagnostics in oncology, women’s health, and organ health. The company’s tests are supported by over 250 peer-reviewed publications, and it operates laboratories that are ISO 13485-certified and CAP-accredited, as well as CLIA-certified in Austin, Texas, and San Carlos, California.
This news is based on a press release statement and reflects the expansion of Medicare coverage for Natera’s Signatera test, marking an important step in cancer surveillance for NSCLC patients. The company’s stock has delivered an impressive 125% return over the past year, though InvestingPro data shows it’s not yet profitable. With 11 additional ProTips available and real-time financial metrics, InvestingPro subscribers can gain deeper insights into Natera’s investment potential.
In other recent news, Natera has been in the spotlight with several significant developments. The company reported positive study results for its Signatera test in colorectal cancer studies, which were highlighted at the ASCO GI conference. Canaccord Genuity maintained its Buy rating and $180 price target, citing the test’s predictive value in disease-free and overall survival benefits after surgery. Raymond (NSE:RYMD) James also reaffirmed its Outperform rating with a $175 price target, acknowledging updates to the National Comprehensive Cancer Network (NCCN) guidelines that recognize the prognostic value of circulating tumor DNA (ctDNA) tests like Signatera.
Barclays (LON:BARC) initiated coverage on Natera with an Overweight rating and a $200 price target, emphasizing the company’s expansion into new markets and its leadership in the minimal residual disease (MRD) space. Additionally, Natera has expanded its patent infringement lawsuit against NeoGenomics (NASDAQ:NEO), with the District Court allowing the inclusion of an additional patent in the case. This legal action seeks comprehensive remedies, including injunctive relief against NeoGenomics’ RaDaR test. These developments reflect a period of strategic growth and legal maneuvering for Natera.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.