Exact Sciences preliminary data released for their blood based CRC screening test

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3,000 samples

Sensitivity of 88 percent for colorectal cancer

Sensitivity of 31 percent for advanced adenomas, a type of precancerous lesion

Specificity was 90 percent

Clinical validation results from BLUE-C will be made public in the first half of 2025 and that data will support submission to the US Food and Drug Administration for marketing approval

Exact Sciences Blood-Based Colon Cancer Screening Data atESMO Exceeds Expectations

Sep 16, 2024 |

NEW YORK – Exact Sciences on Monday shared the first data for its blood-based colorectal cancer screening test, reporting sensitivity of 88 percent for colorectal cancer and 31 percent for advanced adenomas, a type of precancerous lesion. The assay's specificity was 90 percent.

In morning trade on the Nasdaq, Exact Sciences' shares were up about 4 percent at $68.16 on the news.

In a presentation at the European Society for Medical Oncology Congress, the firm described results of a study that included more than 3,000 blood samples, including approximately 2,900 blinded, prospectively collected samples from the firm's BLUE-C trial.

Exact described the study as an optimization of its final test algorithm, designed to simulate a real-world US screening population. Among the samples were 90 advanced adenomas, more than half of which were collected prospectively. Another 60 samples were retrospective, known cancer-positives.

The firm also cautioned that it expects its pivotal BLUE-C study results to feature lower overall CRC and advanced adenoma sensitivity.

According to Exact, these updated clinical validation results from BLUE-C will be made public in the first half of 2025 and that data will support its submission to the US Food and Drug Administration. The company said that samples used for the current analysis will be excluded from the final clinical validation.

Exact's prime competitor in CRC screening is Guardant Health, which has a head start in bringing its own blood-based test to market having received approval from the FDA earlier this year. In Monday morning trading on the Nasdaq, shares of Guardant were down around 9 percent.

Throughout both companies' blood test development process, Exact has stressed the importance of adenoma detection, first as a differentiator for its stool-based Cologuard assay and now for its blood-based test.

"A blood-based colorectal cancer screening test that can detect advanced precancerous lesions at a level comparable to the FIT test would be a breakthrough in this field," Paul Limburg, Exact's chief medical officer for screening, said in a statement.

In an email to investors, Vijay Kumar of investment bank Evercore wrote that the key question for investors is whether the data presented at ESMO is predictive of what the firm will demonstrate in its anticipated readout for the larger BLUE-C cohort next year. The US Centers for Medicare and Medicaid Services has mandated, via a 2021 National Coverage Determination, that blood-based CRC screening tests would be covered as long as they have at least 90 percent specificity and 74 percent sensitivity.

Kumar noted that, based on confidence intervals for the current data, Exact's test specificity is unlikely to decrease significantly. However, he noted that the company did specifically caution that sensitivity could be lower in its pivotal results than in the current analysis.

Dan Brennan of investment bank TD Cowen wrote that the results outperformed what many had expected, based on his firm's survey of investors. Although Exact has cautioned that its performance will likely degrade from the current results to its final pivotal readout, Brennan noted that company executives have said separately that it expects this degradation to be less significant than might be expected.