Trajan Expands US Availability of Harpera™ Microbiopsy Punch for Clinical Skin Sampling

As healthcare and research organizations continue to seek patient-friendly sampling approaches, the Harpera Microbiopsy Punch offers a minimally invasive alternative to traditional skin biopsy methods that may help reduce collection burden while enabling access to high-quality biological samples for modern molecular techniques. The suture-free device option supports a range of applications, including dermatology, biomarker discovery, molecular analysis, translational research, and longitudinal skin sampling.

 

The Harpera tool is designed to collect cutaneous skin samples using a minimally invasive Microbiopsy approach that requires little pre- or post-procedure intervention. The technology supports high-quality biological sample collection while minimizing disruption to patients, making it well suited for repeated sampling across research and clinical workflows.

 

"Healthcare professionals and researchers are increasingly looking for sampling approaches that improve the patient experience while expanding access to patients without compromising sample quality, " said Corinna Rockenbach, Vice President, Clinical Solutions at Trajan. "With FDA registration, the Harpera Microbiopsy Punch is now available for clinical skin sampling in the United States to support advances in dermatology, biomarker research, and precision medicine."

 

Since its introduction in 2021, Harpera devices have supported skin research globally and have been used by organizations advancing precision dermatology, consumer health, and translational research. Early adopters of the technology include organizations such as Procter & Gamble and cuTEST. FDA registration marks an important milestone by expanding access to the technology for healthcare professionals in the United States.

 

Trajan is a global developer and manufacturer of analytical, life sciences, and medical technologies founded to enrich personal health through scientific tools and solutions. Our purpose is to support science that benefits people. With more than 650 employees and sites globally, Trajan serves customers worldwide through operations spanning the Americas, Europe, Asia, and Australia. Trajan's products and solutions are used in the analysis of biological, food, and environmental samples and support the move toward decentralized, personalized, data-driven healthcare. For more information, visit www.trajanscimed.com/.

 

The Harpera™ Microbiopsy Punch has been designed, developed, and manufactured in compliance with Trajan's certified ISO 13485:2016 Quality Management System for medical devices and in vitro diagnostics. It is a manual surgical device intended to enable the collection of a specimen from the cutaneous skin surface by a healthcare professional and FDA-registered for marketing in the US. Harpera is made available as an investigational use only (IUO) product for use in performance studies outside of the US. As part of Trajan, the Harpera device is supported by a talented global team and a diverse portfolio of technologies spanning analytical science, sample collection, automation, and laboratory workflows. This combination of expertise and innovation enables Trajan to deliver trusted solutions that help advance research, improve access to testing, and generate meaningful health insights. For more information, visit www.trajanscimed.com/microsampling/.