P2365 - A Retrospective Descriptive Study of Mail-In Fecal Immunochemical Test (FIT) Use

Daniel Kreitzberg, MS, Emma Dion, PharmD, Devon Humphreys, MA, Timothy Bauer, PhD
Everlywell, Inc., Austin, TX

Introduction: Colorectal cancer (CRC) screening has been demonstrated to decrease CRC mortality. Fecal Immunochemical Tests (FIT) are highly sensitive stool based tests that can be self-collected, at-home, and mailed to a laboratory for testing. The United States Preventive Services Task Force recommends annual FIT for adults aged 45 to 75 years and the US Multi-Society Task Force on Colorectal Cancer ranks it alongside colonoscopy as a first-tier screening option.1,2 A rapid decline in CRC screenings at the onset of the COVID-19 pandemic, further bolstered the utility of mail-in FIT and its potential to augment access to screening and reduce strain on healthcare facilities performing colonoscopy. This study aims to characterize utilization and prevalence of positive results in a consumer-initiated mail-in FIT population.

Methods: A retrospective analysis of aggregate, de-identified mail-in FIT results between between May 2020﹣March 2021 was performed. Clinical specimens associated with the data were processed using a CLIA-waived test.

Results: A total of 1,640 valid test results were included, of which, 914 (55.7%) were women and the mean (SD) age was 58.5 (8.5) years. Of the valid test results, a total of 212 (12.9%) tests were positive. An omnibus test of differences in proportion of positive results among all four geographic regions found a significant difference (p < 0.05) with greater prevalence noted in the Northeast and Midwest compared to the South and West regions.

Discussion: Utilization of consumer-initiated, mail-in FIT was lowest in the Northeast region, a finding that is discordant with national trends in CRC screening rates where the Northeast and Midwest have the highest and second highest CRC screening rates, respectively. Prevalence of positive tests among the study population was lowest in the West region and consistent with national estimates of CRC incidence by region. However, prevalence of positive tests in the Northeast and South regions differed from trends observed in national estimates of disease incidence. The observed differences in mail-in test utilization among males and by geographic region supports targeted outreach efforts to further understand factors that influence mail-in FIT use and to address individual and population-level barriers to mail-in FIT use.
1. US Preventive Services Task Force. JAMA. May 2021;1965–1977.

2. Rex DK, Boland CR, Dominitz JA, et al. Am J Gastroenterol. July 2017;1016–1030.

Characteristic	Prevalence of Test Utilization (N = 1,640)		Prevalence of Positive Tests (N = 212)
	No. (%)	95% CI	No. (%)	95% CI	P-Value
Biological Sex
Male	726 (44.3%)	41.8% - 46.7%	101 (13.9%)	11.5% - 16.6%	0.35
Female	914 (55.7%)	53.2% - 58.2%	111 (12.1%)	10.1% - 14.4%
Geographic Region
West	537 (32.7%)	30.5% - 35.1%	53 (9.9%)	7.5% - 12.7%	0.02
South	642 (39.1%)	36.8% - 41.6%	85 (13.2%)	10.7% - 16.1%
Northeast	184 (11.2%)	9.7% - 12.8%	32 (17.4%)	12.2% - 23.6%
Midwest	277 (16.9%)	15.1% - 18.8%	42 (15.2%)	11.2% - 19.9%

Table: Mail-In FIT Utilization and FIT Positive Results by Biological Sex and Geographic Region


Disclosures:
Daniel Kreitzberg: Everlywell, Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Emma Dion: Everlywell, Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Devon Humphreys: Everlywell, Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).
Timothy Bauer: Everlywell, Inc. – Employee, Stockholder/Ownership Interest (excluding diversified mutual funds).


Daniel Kreitzberg, MS, Emma Dion, PharmD, Devon Humphreys, MA, Timothy Bauer, PhD. P2365 - A Retrospective Descriptive Study of Mail-In Fecal Immunochemical Test (FIT) Use, ACG 2021 Annual Scientific Meeting Abstracts. Las Vegas, Nevada: American College of Gastroenterology.