Guardant Health has reported an encouraging clinical readout update on the performance of its latest algorithm for the Shield blood test for colorectal cancer (CRC) screening.
The latest screening algorithm, Shield V2, has met all primary endpoints in the trial, demonstrating an 84% sensitivity and a 90% specificity for CRC detection.
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Shield V2鈥檚 sensitivity for identifying stage I CRC stood at 62%.
The clinical validation was part of the ECLIPSE study, which involved more than 20,000 participants and assessed the Shield test’s performance in average-risk adults.
The findings indicate that the early-stage CRC sensitivity was 62% for stage I and 100% for stage II.
Sensitivity rates stood at 96% and 100% for stages III and IV, respectively, as well as a 13% detection rate for advanced adenomas.
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By GlobalDataGuardant Health co-CEO AmirAli Talasaz said: 鈥淲e are pleased with the performance of the new algorithm in detecting stage I CRCs. Today鈥檚 update shows yet again that Shield delivers best-in-class performance.
鈥淲e will continue to leverage our first mover advantage, rapidly growing database and innovation engine to push Shield to higher levels of performance over time.鈥�
Recently, the National Comprehensive Cancer Network (NCCN) updated its guidelines to include Shield as the first Food and Drug Administration (FDA)-approved blood test for primary CRC screening.
Guardant Health is also advancing its Shield platform, which includes the Shield multi-cancer detection (MCD) test.
This test has received a breakthrough device designation from the FDA and is part of the National Cancer Institute鈥檚 Vanguard study.
Shield is claimed to be the only blood test fully approved by the FDA for primary CRC screening in average-risk adults aged 45 and above, and can be prescribed by any healthcare provider.
