Blood Test Proves Highly Accurate in Detecting Multiple Cancers in Early Stage

New data has demonstrated the ability of an investigational next-generation multi-cancer assay to accurately detect early-stage cancers.

Guardant Health, Inc.’s (Redwood City, CA, USA) Guardant SHIELD multi-cancer assay is designed to analyze approximately 20,000 epigenomic biomarkers that are informative for detection of a wide range of solid tumors in a single blood test. The data for four cancer types were demonstrated as examples: colorectal, lung, pancreatic and bladder. In addition, the blood test identified the tumor tissue of origin with high accuracy. The investigational next-generation Guardant SHIELD multi-cancer test aims to detect early-stage cancer where there is a clinical benefit from early detection and treatment. In January 2022, Guardant initiated the SHIELD Lung study, a prospective, observational, multi-center basket study designed to enroll individuals undergoing cancer screening across multiple cancer types.

The new data showed that the Guardant SHIELD multi-cancer screening assay achieved sensitivity (detection rates) of 90% in stages I and II colorectal cancer (CRC) and 87% in stages I and II lung cancer. For more advanced cancer (stages III and IV), sensitivity was 93% for CRC and 93% for lung cancer. Detection was assessed at 90% specificity (true negative rates) based on a cohort of patients without cancer. This performance was on par with the current guideline-recommended screening methods. Current screening options for these cancers, while effective, are limited due to low compliance rates: 66% for CRC and 14% for lung cancer. A high-performance blood test that can be completed as part of a routine patient workup has the potential to improve screening rates and, ultimately, save more lives.

In addition, the multi-cancer screening assay achieved sensitivity of 73% in stages I and II pancreatic cancer and 52% in stages I and II bladder cancer. For more advanced cancer (stages III and IV), sensitivity was 84% in pancreatic cancer and 85% in bladder cancer. Since there is no screening paradigm or diagnostic pathway for these cancers, a specificity threshold of 95% was targeted to reduce false positive rates while ensuring sensitivity is clinically impactful. Highly accurate tumor tissue of origin prediction is needed when more than one cancer type is evaluated as part of a single assay to help direct patients to the most effective follow up for a positive test. The tumor tissue of origin prediction was evaluated at 98% specificity and correctly identified the tumor tissue of origin in 99% of colorectal, 94% of lung, 88% of bladder, and 86% of pancreatic cancers.

“These positive results show that the next-generation Guardant SHIELD multi-cancer assay provides sensitive detection of early-stage cancers with the ability to identify the tumor tissue of origin with high accuracy,” said AmirAli Talasaz, Guardant Health co-CEO. “Presentation of these positive results represents a major step forward in our commitment to offering clinicians and patients a highly sensitive blood-based multi-cancer screening test in select tumor types where we believe cancer screening can save lives.”

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