Investor Presentaiton
Reimbursement pathway for Shield starts with
colorectal cancer indication
INVESTOR 20
DAY 23
>shield™ CRC
Clear pathway
starting with
CRC
Medicare Coverage
Blood-based CRC screening NCD
with 3-year interval
Private Coverage
ACS and USPSTF guidelines
Access
~120M individuals
National Coverage Determination (NCD)
Colorectal Cancer Screening Tests
210.3
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Effective for dates of service on or after January 19, 2021, a blood-based biomarker test is covered as an appropriate
colorectal cancer screening test once every 3 years for Medicare beneficiaries when performed in a Clinical Laboratory
Improvement Act (CLIA)-certified laboratory, when ordered by a treating physician and when all of the following
requirements are met:
The patient is:
⚫ age 50-85 years, and,
asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal
pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and,
at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or
inflammatory bowel disease, including Crohn's Disease and ulcerative colitis; no family history of colorectal
cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).
The blood-based biomarker screening test must have all of the following:
• Food and Drug Administration (FDA) market authorization with an indication for colorectal cancer screening; and,
⚫proven test performance characteristics for a blood-based screening test with both sensitivity greater than or equal to
74% and specificity greater than or equal to 90% in the detection of colorectal cancer compared to the recognized
standard (accepted as colonoscopy at this time), as minimal threshold levels, based on the pivotal studies included in
the FDA labeling
National Coverage Determination
by CMS
GUARDANT™
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