New products, new revenue estimates

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Thanks largely to sales of its Cologuard Plus, Madison’s Exact Sciences generated record revenue in the second quarter of 2025, and the release of two new products could help drive revenue gains even higher in subsequent quarters.

Exact Sciences reported second quarter revenue of $811 million, an increase of 16% over the same period in 2024.

The result included screening revenue of $628 million, an increase of 18% over the same quarter in 2024, and precision oncology revenue of $183 million, an increase of 9% over the same period a year ago.

Exact Sciences also announced it was trimming costs and would lay off about 4% of its workforce, around 200 employees, including 80 in Madison.

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Kevin Conroy, CEO of Exact Sciences
Kevin Conroy, CEO of Exact Sciences (Exact Sciences)

During Exact Sciences’ second quarter earnings call on Aug. 6, CEO Kevin Conroy attributed the revenue performance to strong momentum behind the launch of Cologuard Plus, an updated stool test for colon cancer that has been shown to detect more cancers and yield fewer false positives than the company’s original Cologuard.

In the second quarter, Conroy said the company delivered its 20 millionth Cologuard result, doubling from 10 million in just three years, and he said its brand awareness has never been higher.

Cologuard Plus was introduced on March 31, the day before the second quarter began, so it had the entire second quarter to make its initial impact.It intensified a trend that Conroy has touted in recent quarterly reports.

“The colon cancer screening landscape is shifting toward a Cologuard-first, colonoscopy-when-needed approach,” he said.

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As a result of the record quarter, Exact Sciences raised its total revenue guidance to between $3.13 billion and $3.17 billion for the year, an increase of $55 million. This assumes screening revenue of $630 million to $640 million for the third quarter and between $2.44 billion and $2.47 billion for the year, and precision oncology revenue between $170 million and $175 million for the third quarter and from $690 million to $700 million for the year.

New products, new revenue estimates
Exact Sciences

New products, new revenue estimates
Exact Sciences

New products, new revenue estimates
Exact Sciences

Exact Sciences' second quarter revenue was driven by Cologuard Plus. It also introduced Oncodetect, now covered by Medicare.
Exact Sciences' second quarter revenue was driven by Cologuard Plus. It also introduced Oncodetect, now covered by Medicare. (Exact Sciences)

More in the pipeline

The April 22 introduction of Oncodetect, a test that detects up to 200 DNA variants — identifying signs of colorectal cancer (CRC) recurrence up to two years earlier than imaging — was not as notable compared to other aspects of the quarterly report.

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However, the tide might be turning. In July, the company announced it gained Medicare coverage for Oncodetect for serial (repeated) use in patients with stage II, III and resectable (removable) stage IV colorectal cancer.

In securing Medicare reimbursement, Conroy said Exact Sciences’ oncology team “unlocked access for cancer patients.”

He said prior research supports the company’s belief that Oncodetect will play a critical role in guiding treatment after a cancer diagnosis.

Exact Sciences also announced the planned September release of Cancerguard, a new test designed to detect multiple cancers in their earliest stages from a single blood draw.

Cancerguard is aimed at the approximately 70% of cancers that lack a recommended screening solution.

Conroy said this new screening product represents “a significant unmet clinical need in a largely untapped, $25 billion addressable market.”

License to treat

Also during its earnings call, Exact Sciences announced it entered into an licensing agreement with the California biotech company Freenome, giving it exclusive rights to current and future versions of Freenome’s blood-based colorectal cancer screening tests.

Conroy acknowledged disappointing results from Exact Sciences’ own lab-generated, CRC blood screen, but he said Freenome’s technology is promising.

He cited the findings from an early study, recently published in JAMA, the peer-reviewed Journal of the American Medical Association, which showed the first version of Freenome’s test achieved sensitivities of 81% for CRC and 14% for advanced precancerous lesions (APL) at specificity of 90%.

With the agreement, Conroy said Freenome’s blood-based test “is now ours” with an exclusive license and a niche market waiting to be served.

Under the terms of the agreement with Exact Sciences, Freenome will receive $75 million in cash payable by November. Additional potential payments of up to $700 million are based on the achievement of certain milestones for its blood-based CRC screening tests.

In addition, Freenome may be eligible to receive royalty rates of up to 10% based on the test’s profitability.

If certain criteria are not met, Exact Sciences will have the right to terminate the agreement.

“Their version one test has strong data and it accelerates our time to market,” Conroy said. “Version two shows potential promise. We’ve seen data there that shows a potentially improved APL detection.

“We will be able to deploy that test if it does indeed have improved performance, so the (deal) structure gives us maximum flexibility as we continue to lead in this market.”

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