CMS CRC Decision Keeps Cologuard at the Fore and Creates Path for SimpleScreen

研报英文原文证据摘录

CMS CRC Decision Keeps Cologuard at the Fore and Creates Path for SimpleScreen

Medical Supplies & Devices

Abbott Laboratories

TD SECURITIES (USA) LLC QUICK TAKE: COMPANY UPDATE

June 9, 2026

Price: $90.50 (06/8/2026) CMS CRC Decision Keeps Cologuard at the

Price Target: $115.00 Fore and Creates Path for SimpleScreen

BUY (1)

ESG SCORE: 58/100

Joshua Jennings, M.D. THE TD COWEN INSIGHT

646 562 1333

CMS published a final decision for CRC non-invasive biomarker tests, which preserved

joshua.jennings@tdsecurities.com

favorable Cologuard reimbursement, created a coverage path for blood-based tests

Colin Clark (SimpleScreen), established clinical thresholds for new entrants, and aligned screening

646 562 1441 populations to guidelines, in-line with proposal. We remain positive on Cologuard's

colin.clark@tdsecurities.com

defensibility and the potential SimpleScreen coverage pathway.

John Rusch, CFA

646 562 1324 Reimbursement Expands to Include All Non-invasive Biomarker Tests, Which Creates an

john.rusch@tdsecurities.com Easier Path for SimpleScreen

Key Data The CMS memo broadened coverage from a stool DNA-centric framework to a technology-

Symbol NYSE: ABT

agnostic biomarker category, explicitly including RNA-based approaches alongside DNA

Market Cap $157.6B tests. This removes the structural advantage Cologuard historically enjoyed as the primary

covered modality as suggested by the proposal, but we believe the change validates ABT's

broader Dx portfolio strategy: while Cologuard and Cologuard Plus remain core assets, the

SimpleScreen (to be exclusively licensed from Freenome) blood-based program now has a

clearer reimbursement pathway as part of the same covered class.

Explicit Performance Thresholds were Introduced, Creating a Barrier for New Tests