Premarket Approval Submitted for Noninvasive CRC Screening Test

A premarket approval application for a noninvasive diagnostic screening test for colorectal cancer (CRC) and advanced adenomas (AA) was submitted to the FDA by Geneoscopy Inc, according to a press release.¹

The test’s effectiveness is supported by the results of the CRC-PREVENT trial (NCT04739722), where it showed high specificity for CRC and AA. The test elicited 94% sensitivity for CRC and 45% sensitivity for AA in average-risk individuals, which is the highest reported sensitivity for any prospective study of a noninvasive screening test.

“We are committed to closing this gap for patients who require screening and look forward to working with the FDA to bring a convenient and reliable screening option to patients that may allow for earlier detection and treatment – and potentially save lives,” Erica Barnell, PhD, chief science officer and Geneoscopy’s co-founder, said in a press release.

The screening test, which received the FDA’s breakthrough designation in January 2021, is based on extracting eukaryotic RNA biomarkers from stool samples to be analyzed at Geneoscopy’s St. Louis-based laboratory.

The CRC-PREVENT trial included 8289 individuals across more than 2900 zip codes in the contiguous United States, which enabled the trial to assess the test’s performance in individuals in different demographics and socioeconomic circumstances.²

Participants used a collection kit to submit samples by express mail to be analyzed, and underwent an optical colonoscopy examination. Investigators performed a comparative analysis of the findings of the screening test and the colonoscopy for sensitivities and specificities, including CRC, precancerous AA, high-grade dysplasia, other adenomas, and negative findings.

Sensitivity was determined by the percentage of individuals whose diagnosis by colonoscopy was detected as positive by the screening test. Specificity was determined by the percentage who were found to have benign polyps or no findings on colonoscopy who had a negative test.

In addition to its high sensitivity for CRC and AA, the test showed 88% specificity for no findings on a colonoscopy, which is required to reduce the rate of false positivity that could lead to unnecessary colonoscopies.² In the 45-49 age population, the test showed 100% sensitivity for CRC and 44% sensitivity for AA, at an 89% specificity. This younger age group is now included as a recommended screening population by the United States Preventive Services Task Force and the American Cancer Society.¹ This is the first prospective study where a stool-based test was able to detect CRC in individuals 45-49 years of age.²

“Over 50 million Americans between the ages of 45 and 85 are eligible to be screened for CRC,” Barnell said in the press release.¹ “Unfortunately, despite CRC being the second leading cause of cancer death in the US, millions of eligible Americans do not get screened – many due to a lack of knowledge of the importance of screening, lack of access to screening and concerns about the invasive nature of options like colonoscopy.”

Following the FDA’s review of the premarket approval application, the screening test could be made available commercially for use in the US, allowing a noninvasive option for earlier detection of CRC.

_References:

_{1. Geneoscopy submits premarket approval application to FDA for its noninvasive colorectal cancer RNA biomarker screening test. News release. Geneoscopy. January 24, 2023. Accessed January 26, 2023. https://bit.ly/3R7pqLa}

_{2. Geneoscopy’s noninvasive colorectal cancer screening test demonstrates high sensitivity and specificity in large pivotal clinical trial. News release. Geneoscopy. January 10, 2023. Accessed January 26, 2023. https://bit.ly/3DdBZPx}