NEW YORK – Thorne HealthTech said Thursday it received CE marking for its NanoDrop instrument for collection of capillary whole-blood samples.
The New York City-based firm said the regulatory authorization will enable the development of testing applications that incorporate its technology into a home-use device. It added the NanoDrop instrument contains the same dual lancet technology as the firm's OneDraw blood collection instrument, which has Food and Drug Administration 510(k) clearance for use under the supervision of healthcare professionals.
The OneDraw instrument, which Thorne gained with its 2021 acquisition of the majority of outstanding shares of Drawbridge Health, uses two miniature lancets to make an incision in the skin and a vacuum to draw blood to the skin surface for collection in a dried stabilization matrix and removable cartridge.
Thorne HealthTech CEO Paul Jacobson said in a statement the firm anticipates making the NanoDrop collection instrument available across the European Union, and he noted that the One Draw instrument received regulatory clearance in Japan in August 2022. Thorne Co-CEO Jerome Scelza said in a statement the NanoDrop instrument offers companies an opportunity to integrate Thorne's technology into more testing and sample collection applications.
"We specifically wanted to ensure the broadest population of individuals had access to our industry-leading, near-painless, and non-invasive technology," he said. "We've seen a huge influx of remote testing demand, and we are making a big push to deploy solutions that will support our own customers as well as our great partners building the healthcare of tomorrow."