Exact Sciences Stock, A Cathie Wood Holding, Could Pop After Cologuard 2.0 Outperforms In A Four-Year Test – Investor’s Business Daily
Exact Sciences (EXAS) announced Wednesday that its next-generation Cologuard outperformed a rival stool-based screening test for colon cancer. The news is expected to boost Exact Sciences stock, which investor Cathie Wood holds in her ARK Innovation ETF (ARKK).
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The company is well known for Cologuard, a screening tool for colorectal cancer. Patients can send in a stool sample for analysis rather than opting for an invasive colonoscopy. But the original Cologuard has an overall specificity of 87%, meaning some patients get false positives.
Enter Cologuard Plus.
The next-generation screening tool showed an overall specificity of 91% over the four-year study Exact calls Blue-C. The results could help Exact Sciences overtake its 50-day moving average, where shares have traded since mid-January, according to MarketSurge.com.
“We have reduced the number of false positives,” Dr. Paul Limburg told Investor’s Business Daily. Limburg is the chief medical officer for Exact’s screening division. “The specificity is higher, so when the test is clinically available, this should translate into a reduced number of false positives and unnecessary colonoscopies when patients use this next-generation test.”
Exact Sciences Stock: Rivaling FIT, Colonoscopy
Exact Sciences ran its Blue-C study from 2019 to 2023. The company enrolled nearly 27,000 people to undergo a colonoscopy, a fecal immunochemical test — also called FIT — and the next-generation Cologuard. FIT is another screening tool that involves analyzing a patient’s stool.
FIT and Cologuard are both screening tools. This means when patients receive a positive, then they must undergo a colonoscopy to confirm the presence of cancer. But while the FIT test looks for the presence of hemoglobin, a protein found in the blood, Cologuard Plus looks for hemoglobin and three DNA markers of cancer.
Bullishly for Exact Sciences stock, Cologuard Plus outperformed FIT across four of six parameters measuring sensitivity. Sensitivity is a test’s ability to identify a patient with the disease as positive. The next-generation Cologuard had a higher sensitivity for detecting all cancer, stages one through three cancers, pre-cancers and an aggressive form of pre-cancer called high-grade dysplasia.
However, though Cologuard Plus improved on the original Cologuard’s specificity, it fell slightly short of the specificity demonstrated by FIT. FIT had a sensitivity of 95% to 96%, whereas Cologuard Plus had a specificity of 91% to 93%.
But Limburg focused on the improvement over the original Cologuard.
“We know we can always do better,” he said. “We wanted to increase specificity to reduce false positives.”
A Huge Colon Cancer Screening Market
Though fourth-quarter sales easily beat forecasts, Exact Sciences stock has been under pressure recently. In addition to trading below its 50-day line, shares have remained below their 200-day moving average since September.
But Exact shares land on Cathie Wood’s famous exchange-traded fund. They rank No. 23 out of 38 holdings in terms of weight in the fund.
The market for colorectal cancer screening is huge. The American Cancer Society recommends people begin screening regularly after age 45. But some 60 million people in the U.S. aren’t up to date with screening recommendations, Exact Sciences’ Limburg says.
“Colorectal cancer is a highly preventable disease and we know that screening is a very effective way to find colorectal cancer early, but also to find pre-cancers so that they can be appropriately treated and truly prevent the pre-cancer from becoming more aggressive and turning into cancer,” he said.
Blood-Based Tests Remain Nascent
Exact Sciences is also working on a blood-based screening tool for colon cancer. But results from other companies suggest it will be some time before blood-based tests catch up to the specificity and sensitivity of stool-based screening tools, Limburg said.
Meanwhile, Cologuard Plus is yet another option to help patients screen for colon cancer, he said. The company hopes the Food and Drug Administration will sign off on Cologuard Plus later this year, leading to a launch in 2025.
“This is a better-performing version of an already well-established and growing adoption of a noninvasive colorectal cancer screening test,” he said. “We believe this next-generation Cologuard test will even better meet the needs of patients and providers.”
Follow Allison Gatlin on X, the platform formerly known as Twitter, at @IBD_AGatlin.
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