NTRA: Signatera Receives IVDR Certification

研报英文原文证据摘录

NTRA: Signatera Receives IVDR Certification

FLASH NOTE

July 9, 2026

Subbu Nambi, Ph.D. subbu.nambi@guggenheimpartners.com NTRA: Signatera Receives IVDR Certification

617 874 7383

Ricki Levitus Key Message: This morning, NTRA announced that Signatera has received IVDR

ricki.levitus@guggenheimpartners.com certification as a Class C device under the EU IVDR. We view this as another milestone

212 823 6556 along the international regulatory path for Signatera. The IVDR certification will make

Thomas VonDerVellen it easier to develop and launch clinical trials in EU regions, and as this evidence is

thomas.vondervellen@guggenheimpartners.com generated we would expect it to increase adoption of Signatera in these markets over

617 859 4657 time.

What Happened & What it Means

Signatera was certified as a Class C device under the European Union’s In VitroNTRA •

Diagnostic Regulation (IVDR). The IVDR is the EU's medical device regulation, which Natera, Inc.

Sector: Diagnostics & Life Sciences Tools has replaced the IVDD framework (transition period through 2028). IVDR has strict

requirements for all aspects of a diagnostic test: the assay, the reagents, the sample

Company Update collection kit, and even the analysis software. Assay performance in terms of analytical

Share Price $274.39 validity and clinical validity are also assessed as part of this process.

Signatera was certified as a Class C device. Classes span A through D, with the individual •

and public health risks related to the device escalating alphabetically. Class C devices

Market Data include those that guide disease management, including cancer.

Signatera received IVDR Class C certification for adjuvant and surveillance indications for 52-Week Range $131.81 - $288.04 •