
YourBio’s TAP Micro Receives CE Marking Joining Tasso+ As Cleared Technologies for Self Blood Collection; Cost and Volume Challenges Remain for Broadscale Adoption
11-1-23 (by: Scott Gleason) Boston-based YourBio Health has achieved a major regulatory milestone and has announced that it has obtained regulatory approval for its TAP® Micro Select blood collection device, gaining certification for CE Marking. The technology offers painless blood sample collection using a bladeless microneedle array, and 95% of users say they would use the collection device again. This certification will help increase its use for broader applications, including clinical trials and home-based diagnostic and wellness testing.
The TAP® Micro Select blood collection device is powered by YourBio Health’s patented Halo™ technology, which employs a bladeless microneedle array for virtually painless blood sample collection. This approach to blood collection aims to replace traditional venous blood collection and finger stick tests, offering patients a more comfortable experience. It also enables the possibility of home-based administration for many diagnostic and wellness tests. In April of 2023, the company announced the technology had also received FDA approval for the device.
YourBio Health’s capillary whole blood collection technology has wide-reaching applications. By offering a less painful and more patient-friendly approach to blood collection, it has the potential for use in decentralized clinical trials and for use with some advanced diagnostic and wellness tests. The TAP® Micro Select device is designed to produce high-quality blood samples in high volumes, which can be processed at any central lab. The devices can collect up to 500μl of whole blood. This volume can be challenging for many diagnostics though. Most basic chemical blood tests require 2,500μl. Cost and the use of capillary whole blood versus venous serum can also be a consideration for customers.
In September 2022, Competitor Tasso became the first company to get FDA approval for a self-blood collection device with its Tasso+™ system and in February 2023 the device received CE Mark. The Tasso+ device can also collect 200-600μl of capillary whole blood. Its device costs $25 to $35 making it prohibitive for many diagnostic indications.