NTRA: Signatera PMDA Approval in Japan for CRC a Positive Catalyst

研报英文原文证据摘录

NTRA: Signatera PMDA Approval in Japan for CRC a Positive Catalyst

EQUITY RESEARCH QUICK TAKE

RBC Capital Markets, LLC

Dan Leonard (Analyst)

June 24, 2026

Natera, Inc.

Signatera PMDA Approval in Japan for CRC a Positive Catalyst

NASDAQ: NTRA | USD 234.76 | Outperform | Price Target USD 275.00

Sentiment: Positive

Natera announced today that Signatera has received PMDA approval for colorectal cancer in Japan (the first MRD test approved

in the country) with commercial launch expected by year-end 2026, pending final pricing determination.

• Timing as Expected; 2027 Sales Contributor. Today’s PMDA approval for Signatera in colorectal cancer was in line with our

expectations. Japanese regulatory approval was listed as a near-term potential catalyst in our June 11 resumption. Commercial

launch is now slated for year-end 2026, subject to final pricing determination. Given the typical lag between regulatory approval

and reimbursement establishment in Japan, we continue to model Japan as a modest 2027 revenue contributor. We are not

changing estimates at this time.

• CRC Incidence Comparable to the U.S. Japan sees more than 150,000 new CRC diagnoses annually, making it one of the

country’s most common cancers and a market broadly comparable in size to the United States. With Natera’s current geographic

footprint concentrated at >95% U.S. revenue, the Japan CRC opportunity represents a meaningful incremental addressable

market, essentially a CRC opportunity that is second only to the U.S. SRL Inc., the largest reference lab in Japan and part of the

H.U. Group, will serve as Natera’s exclusive commercial partner, providing nationwide lab distribution that should accelerate

uptake once reimbursement is in place.

• Clinical Evidence Rooted in Japan: CIRCULATE-Japan / GALAXY.