NTRA News & Events

Natera announced two peer-reviewed publications highlighting the clinical utility of Signatera, its personalized, tumor-informed circulating tumor DNA assay, in anal squamous cell carcinoma and locally advanced rectal cancer. ASCC: publication in Nature Communications: A recently published study evaluated 84 patients with ASCC to assess whether serial Signatera testing may offer a dynamic, treatment-responsive biomarker to further stratify recurrence risk and inform surveillance and treatment. Key findings include: Signatera-status was strongly correlated with clinical outcomes. Patients who were Signatera-negative at baseline or cleared ctDNA during chemoradiotherapy had favorable outcomes, including 100% one-year overall survival and progression-free survival, and 0% one-year local regional failure. Patients who remained ctDNA-positive after CRT had poorer outcomes. In 100% of recurrent cases, Signatera-positivity preceded clinical and/or radiographic recurrence highlighting ctDNA's potential as an early indicator of relapse. LARC: publication in Cancers: Another recent study evaluated 220 patients with LARC treated with neoadjuvant therapy followed by non-operative management or surgery. The study examined how Signatera status after NAT may inform patient selection for organ-preserving NOM versus surgery and guide intensified surveillance strategies. Key findings include: Signatera identified post-NAT patients at high risk of relapse requiring surgical intervention. Signatera-positive NOM patients were at 4.6x higher risk of regrowth requiring surgery, even among those with a complete or near-complete clinical response. Post-operative Signatera negativity was associated with excellent clinical outcomes. Signatera-negative patients experienced a relapse rate of 11.5% compared to 88.0% among Signatera-positive patients.

Shares of GeneDx are down $3.70 to $81.40 in premarket trading.

Natera (NTRA) announced the commercial launch of Zenith genomics, the company's whole genome sequencing assay designed to improve the detection of rare diseases. The company said, "Zenith genomics was built to address one of the most critical challenges in medicine: timely and accurate diagnosis of rare genetic conditions. Rare diseases affect an estimated 30 million Americans annually, many of whom experience prolonged diagnostic odysseys. The cumulative economic burden of rare diseases in the United States was nearly $997 billion in 2019, including $449 billion in direct medical costs and $548 billion in indirect and non-medical costs, underscoring the scale of unmet need and societal impact." Shares of GeneDx (WGS), which offers genetic testing for rare diseases, are down 4% to $81.40 in premarket trading.