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

Research evidence excerpt

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