Natera Inc. (NTRA): First Take: Signatera approved in Japan for CRC in the adjuvant setting

研报英文原文证据摘录

Natera Inc. (NTRA): First Take: Signatera approved in Japan for CRC in the adjuvant setting

Equity Research

24 June 2026 | 10:07AM EDT

Natera Inc. (NTRA): First Take: Signatera approved in Japan for CRC in

the adjuvant setting

This morning, Natera announced it has received Japan’s Pharmaceuticals and Evie Koslosky

+1(212)357-1694 | e.v.koslosky@gs.com

Medical Devices Agency (PMDA) approval for the use of Signatera for patients with Goldman Sachs & Co. LLC

colorectal cancer (CRC) in the adjuvant setting. This approval makes Signatera the Grey Smith

first PMDA-approved molecular residual disease (MRD) test in Japan for CRC, the +1(212)934-1193Goldman Sachs & Co.| grey.smith@gs.comLLC

country’s most common cancer type1. Following this approval, the company will

submit documents to the Japanese Health Ministry for final reimbursement and

pricing determination. Management previously noted the subsequent pricing and

reimbursement process could take ~6-9 months, and are expecting to launch

Signatera in Japan later this year, once final pricing is established. We will be

watching for more details on potential pricing and longer term opportunities in

expanding testing time points which would further broaden the opportunity in

Japan.

The market opportunity in Japan represents over 150,000 CRC diagnoses annually

which maintains a disease burden comparable to that of the United States.

Additionally, MRD testing is already integrated into the guidelines of the Japan

Society of Clinical Oncology (JSCO) and the Japanese Society of Medical Oncology

(JSMO). Natera is also partnering with SRL, Inc., Japan’s largest reference laboratory,

to support commercial launch of Signatera in the country.

Our View: As Signatera solidifies their first-mover advantage in Japan’s CRC