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Exact Sciences Releases Next-Gen Cologuard Data, Inks New Partnerships

NEW YORK – Exact Sciences this week announced positive topline data for the second-generation version of its Cologuard stool-based colorectal cancer assay. The company also disclosed two new research agreements focused on minimal residual disease and multi-cancer early detection in conjunction with its annual investor day presentation on Wednesday.

Exact said Tuesday afternoon that the new version of Cologuard met all endpoints of its BLUE-C study and showed improvement over the first generation of the test across all topline metrics, including a 30 percent lower false positive rate.

In the no-longer recruiting multi-center prospective study, Exact has tested more than 20,000 adults aged 40 years and older with the improved, multi-target Cologuard assay, comparing results to patients' colonoscopy findings. The company reported that test specificity improved to 91 percent in the study, while sensitivity rose to 94 percent for cancer and 75 percent for high-grade dysplasia.

Thomas Imperiale, professor of medicine at the Indiana University School of Medicine, and principal investigator for BLUE-C, said in a statement that the study results strengthen the case for molecular stool-based testing.

In a note to investors, Vijay Kumar of advisory firm Evercore wrote that the improvements in both specificity and sensitivity are impressive considering that there is usually a tradeoff between the two metrics. With the numbers reported, the study "should dispel any lingering concerns on [market] cannibalization from blood-based tests," he added.

Other investment banks echoed that the results exceeded their expectations. TD Cowen's Dan Brennan wrote that the higher performance seen in the study should not only convert some doctors who saw the first-generation Cologuard's 13 percent false positive as too high, but also increase the firm's opportunity for rescreening.  

The company plans to release additional data analyses and complete its application to the US Food and Drug Administration for approval of next-generation Cologuard "in the coming months."

In its investor day presentation, portions of which Exact made available in a filing with the US Securities and Exchange Commission, the firm outlined expectations in its CRC screening business looking ahead to 2027, when it estimated it will have tested more than 35 million individuals.

The company reiterated its expectations for full-year screening revenues between $1.77 billion and $1.80 billion, and precision oncology revenue of $605 million to $620 million. The firm also added that it expects to report positive cash flow for the soon-to-be-completed second quarter. It also projected 15 percent compounded annual revenue growth between 2022 and 2027.

In Wednesday afternoon trade on the Nasdaq, shares of the firm's stock were down about 4 percent at $90.71.

Exact also announced Wednesday morning that it has made an agreement with the Broad Institute giving it an exclusive license to a proprietary technology for minimal residual disease testing in cancer under a five-year sponsored research agreement.

The MRD technology — called Minor Allele Enriched Sequencing Through Recognition Oligonucleotides (MAESTRO) — is a circulating tumor DNA technology designed to detect thousands of patient-specific mutations using minimal sequencing and advanced bioinformatics, and was originally developed at the Broad Institute's Gerstner Center for Cancer Diagnostics.

Meanwhile, Exact has inked an agreement with Texas healthcare system Baylor Scott & White (BSW) to establish the "Texas Multicancer Early Detection Registry Program," which will implement the firm's MCED test across a subset of BSW primary care clinics, generating real-world evidence to support discussions with regulatory agencies, payers, and guideline bodies. Overall, the program aims to offer testing to 50,000 individuals over three years.

During its investor presentation on Wednesday, the company cited data presented at last year's European Society for Medical Oncology annual meeting in which it was able to improve its test's sensitivity in early-stage tumors by 35 percent.

The test, now called Cancerguard, achieved an overall sensitivity of 52.6 percent with a mean specificity of 98.7 percent.

Citing ongoing patient follow-up data from the prospective DETECT-A trial, Exact reported that all of the individuals in the study who had a diagnosis at stage I or stage II currently remain disease-free more than four years later. Overall, 86 percent of surgically treated participants were in remission as of November 2022.

The company also highlighted that among those with false positive test results — defined as a positive on Exact's assay but a negative follow-up PET-CT — had less than one percent chance of developing cancer over the four-year period.

Researchers involved in DETECT-A wrote in a conference presentation earlier this month that, if confirmed, this could prove reassuring for providers considering ordering multi-cancer screening, providing preliminary evidence that patients who receive a positive MCED result can safely return to routine care if comprehensive imaging fails to uncover a tumor.