Capillon Analytics achieves CLIA registration and is ready to analyze clinical samples from the U.S.

The cancer diagnostics company Capillon Analytics AB (part of Kreftect) has achieved CLIA registration under U.S. regulatory requirements, and can thereby analyze patients’ hair samples from clinical studies in the United States. The registration marks an important step toward establishing the company’s prostate cancer detection test on the U.S. market.

CLIA (Clinical Laboratory Improvement Amendments) is a regulatory requirement for laboratories handling clinical samples from the US. Capillon is currently unique in Sweden to hold this registration, which now enables the analysis of American patient samples at the company’s laboratories in Lund.

In current prostate cancer screening, only one in three men with an elevated PSA level actually has cancer. This creates anxiety and leads to many unnecessary, and sometimes risky, procedures such as biopsies to collect tissue samples and confirm the diagnosis. The need for more accurate methods is therefore significant.

“Our method is based on hair samples from patients, and has the potential to significantly increase the sensitivity to detect clinically relevant prostate cancer. The simple test via hair allows for the physician to make a more informed and relevant decision on treatment and timing options. Next, we will begin analyzing hair samples from men with elevated PSA levels as part of the clinical validation of our method for prostate cancer detection,” says Emma Hammarlund, CEO of Capillon Analytics AB.

The company’s first clinical validation study, involving around 800 patients, will be completed before the summer. After the summer, an additional study with approximately 1,000 patients will follow.

Capillon is initially targeting the U.S. market. In the longer term, the company plans to expand its portfolio to additional cancer types, with breast cancer as the next step for the European market.