US-based biotechnology company Grail has started a multi-centre clinical study, dubbed PATHFINDER, to evaluate the application of its investigational multi-cancer early detection test in clinical practice.

Grail said that the results from its PATHFINDER trial will be returned to healthcare providers and study participants, to guide the diagnostic examination for more than 50 cancer types.

Grail chief executive officer Hans Bishop said: “Grail is at the forefront of transforming early cancer detection as we bring our multi-cancer test into clinical practice through our first interventional study.

“We are partnering with leading healthcare systems to gain important real-world insight into the clinical use of our multi-cancer early detection test, an important step on our path toward commercialization.”

Grail enrolled first participants into the PATHFINDER clinical trial

The PATHFINDER trial is being carried out under an investigational device exemption (IDE) to evaluate the company’s multi-cancer early detection test, which is currently not available for any other use.

The initial health system partners for the study include Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health & Science University, and Sutter Health.

Grail has designed its advanced multi-cancer early detection test to detect cancers in early stages, where the chance of survival is higher.

According to the data from previous clinical studies, Grail’s multi-cancer early detection test is capable of detecting more than 50 types of cancer in all stages, with a very low false positive rate.

When the cancer signal is detected, the test would identify the precise location of cancer in the body, enabling healthcare providers to guide through the diagnostic resolution.

The test deploys methylation-based technology, along with the advanced database and machine-learning algorithms to detect the presence of cancer and identifies the tumour’s tissue of origin.

Grail founder and chief scientific officer Alex Aravanis said: “Grail set out to develop a true multi-cancer early detection test, and we believe we have built the world’s largest methylation database that’s enabled machine learning rooted in fundamental insights into the biology of cancer signals in the blood.

“Building on our foundational investments in science and technology, we developed a high performing test for the detection of over 50 types of cancer, and we are excited to evaluate its ability to inform clinical care.”