YourBio Health, a Boston-based developer in remote, capillary whole blood collection technology, has received further regulatory approval for its TAP Micro Select blood collection device with certification for CE Marking.
This will further advance the progress of the company’s approach to humanizing the process of blood collection, bringing advantages in clinical trials that are necessary to approve much-needed new treatments, as well as applications for home-based, patient-administered testing in diagnostic and wellness product markets, the company says.
On Oct. 11, 2023, GMED, a France-based Notified Body for the assessment of medical devices, delivered the certification contract for use of CE Marking relating to the TAP Micro Select blood collection device.
“With our patented Halo technology within the TAP micro series of blood collection devices, YourBio Health is unique in offering virtually painless blood sample collection using a bladeless microneedle array,” says Harry Wilcox, CEO of YourBio Health. “Regulatory approval will enable our device’s use with commercial blood collection tubes and allow use in kits that revolutionize blood testing in diagnostics and wellness.”
Wilcox continued, “This additional regulatory clearance will further support the trend in decentralized clinical trials and recruitment and maintenance of more diverse patient populations that are known to be more relevant with certain diseases, which will inevitably lead to successes with much needed new treatments, as well as access to treatments for currently underserved and voluntarily unwilling patient groups.”
Remote, capillary whole blood collection offers the opportunity to replace traditional venous blood collection and painful finger stick tests in many applications, making the process of blood collection less daunting for patients and enabling home administration in many cases, leading to significant advantages in clinical trial design, and contributing to product appeal in diagnostic kits and wellness test applications, the company says. YourBio Health’s technology has achieved notable success across these applications, including a fertility program at Columbia University Medical Center in New York.
Zev Williams, MD, PhD, associate professor of Women’s Health and Chief of the Division of Reproductive Endocrinology and Infertility at Columbia University Medical Center, decided to use YourBio Health’s innovative technologies to reduce stress during fertility treatments by eliminating the pain associated with repeated blood draws.
“Frequent blood draws are necessary during fertility treatment to measure hormone levels, which determine when the eggs are ready to be collected, but high frequency traditional phlebotomy can obviously damage veins and cause significant pain,” Williams says. “When we learned about the TAP Micro Select device, we saw a clear opportunity to make this necessary but distressing aspect of the fertility journey much easier and more tolerable for patients.”
The TAP Micro Select blood collection device produces high-quality blood samples in high volumes, which can be processed at any central lab. YourBio Health does not conduct testing but holds patents on the revolutionary devices and offers a range of complementary services, including sample tracking, which can be customized for a broad range of clinical trials, wellness, and clinical-grade blood sampling.
Featured image: The TAP Micro Select blood collection device. Photo: YourBio