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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test

by Ron Shinkman | Nov 1, 2024 | CDC-nir, Essential, FDA-lca, Lab Industry Advisor

Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent

An illustration of the human colon with cancerous mass. — iStock, Mohammed Haneefa Nizamudeen

Thanks to the U.S. Food and Drug Administration (FDA), Little CG has gotten bigger.

That’s the unofficial name for the mascot for Exact Sciences’ Cologuard^® test for colorectal cancer (CRC). It’s an anthropomorphized walking white box sporting a face and Cologuard logo. Little CG represents the ease of use for the test, which can be delivered directly to the patient’s door and returned by mail to Exact for analysis.

Little CG has been immortalized in numerous commercials produced to promote Cologuard, a campaign that has probably made it the best known prescription laboratory test in the US.¹ Exact Sciences has gone even farther in marketing the test using Little CG, launching a gamified version of the mascot in a recent videogame release that is also available on smartphones.²

Now, the company has also taken the next step with the test itself. What it calls the “next generation” version of Cologuard—branded as Cologuard Plus^™—recently received approval from the FDA for screening adults aged 45 and older who are at average risk of colorectal cancer. The revamped assay has added numerous new genetic biomarkers for the disease.³

The original Cologuard test received FDA approval in August 2014 for use in adults age 50 and over with an average risk for colon cancer, which was expanded to include adults 45 and over in 2019 due to the growing number of Americans being diagnosed with the disease at a younger age.^4,5 About 53,000 Americans are expected to die from colorectal cancer this year, according to data from the American Cancer Society.⁶ Although more aggressive testing has put a dent in that number in recent years for older adults, the same isn’t true for those under age 55, with death rates rising roughly 1 to 2 percent per year since the mid-90s, the society adds.⁶

Exact Sciences’ intent has been to offer a screening test that is more palatable to people resistant to undergoing a far more invasive colonoscopy, which requires general anesthesia and comes with a small risk of colon perforation.⁷

The performance of Cologuard Plus

In the recent BLUE-C study— which included screenings of nearly 19,000 average-risk patients with the Cologuard Plus test—the new test demonstrated a 95 percent overall sensitivity to cancer and a 94 percent specificity, stated Exact Sciences in a press release.^8,3 The original Cologuard test has a 92 percent sensitivity and an 87 percent specificity.⁹ The performance of the new test means that false positives from the test should be reduced by more than 30 percent, said Exact Sciences chief executive officer and chairman Kevin Conroy in the press release. The study also concluded that Cologuard Plus “significantly outperformed an independent fecal immunochemical test…for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity,” according to Exact.³

“This breakthrough comes at a critical time, when 60 million Americans are not up to date with [colorectal cancer] screening,” Conroy added in the press release.³

The test is expected to be available by early next year.

CDC revamps laboratory safety division

In other government agency news, the U.S. Centers for Disease Control and Prevention (CDC) has significantly revamped its office overseeing laboratory safety. The former Office of Laboratory Science and Safety has been renamed the Office of Laboratory Systems and Response.

According to a recent posting in the Federal Register, the CDC took the following steps:¹⁰

Abolished the Office of Laboratory Science, the Office of Laboratory Safety; the Center for Laboratory Systems and Response; the Division of Laboratory Systems and its Office of the Director; the National Laboratory Response System Branch; the Quality and Safety Systems Branch; the Training and Workforce Development Branch; the Division of Core Laboratory Services and Response and its Office of the Director; the Advanced Diagnostics and Biotechnologies Branch; the Comparative Medicine Branch; the Preparedness, Response, and Outbreak Services Branch; and the Laboratory Products and Services Branch

In their place, the CDC has established the Division of Laboratory Systems and its Office of the Director; the Laboratory Readiness and Informatics Branch; the Quality and Safety Systems Branch; the Training and Workforce Development Branch; the Division of Core Laboratory Services and Response and its Office of the Director; the Biotechnology Core Facility Branch; the Comparative Medicine Branch; the Preparedness, Response, and Outbreak Services Branch; and the Laboratory Products and Services Branch

The changes all went into effect on September 13, 2024. Longtime CDC executive Reynolds Salerno, PhD, was named the director of the Office of Laboratory Systems and Response. He served as the CDC’s director of the Division of Laboratory Systems between 2016 and 2024.¹¹

The CDC has said virtually nothing officially about the reorganization, which was first proposed in the Federal Register last summer. The CDC website announced that the agency “is committed to advancing the ‘science of laboratory safety’—applying the same rigorous scientific methods to the safety of CDC’s laboratories that CDC uses to confront threats to the public’s health. To spur the science of safety in CDC laboratories [the new offices] support CDC laboratories to advance innovative research or solutions to laboratory safety challenges.”¹²

One laboratory expert says the CDC’s revamp is to ensure the agency can keep pace with the way technology and data are remaking the laboratory sector.

Mitesh Rao, MD, founder and CEO of OMNY Health and former chief patient safety officer at Stanford Healthcare, believes the CDC is repositioning the unit to better process and handle data.

“I think what we realized post pandemic is that in health care, data drives everything,” Rao says. “To be efficient in both pandemic response and broader public health initiatives…a lot of that going into the future is going to be centered on data.”

Rao thinks that the revamp is going to minimize delays in labs and other healthcare entities submitting data to the CDC as well as how data is aggregated and shared with the public.

The COVID-19 pandemic “pushed almost everyone to think about deeper data and better data,” Rao said. “The lack of speed to comprehensive and timely information was one of the biggest barriers [healthcare providers] ran into.”

As for why the CDC has been so quiet about the reorganization of the unit? Rao believes the agency is still trying to figure out how to best deploy the Division of Laboratory Systems.

“I think we’ll see more coming out of the CDC from its requirements and its approaches as they start to get a better grasp on how to approach that space,” he says.