YourBio Health Announces Expanded Regulatory Approval of its Virtually Painless Blood Collection Device
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MEDFORD, Mass., Oct. 31, 2023 /PRNewswire/ -- YourBio Health, a Boston-based pioneer in remote, capillary whole blood collection technology, today announced that it 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 this revolutionary 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.
On October 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.
Harry Wilcox, Chief Executive Officer of YourBio Health, said, "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. 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. YourBio Health's technology has achieved notable success across these applications, including a fertility program at Columbia University Medical Center in New York.
Dr. Zev Williams is Associate Professor of Women's Health and Chief of the Division of Reproductive Endocrinology and Infertility at Columbia University Medical Center. He decided to use YourBio Health's innovative technologies to reduce stress during fertility treatments by eliminating the pain associated with repeated blood draws. Dr. Williams said, "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. 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."
To read more about this usage at Columbia University Medical Center, click here to view their article.
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.
To learn more about YourBio Health, visit yourbiohealth.com.
About YourBio Health
YourBio Health is a Flagship Pioneering portfolio company that invented 'Touch-Activated Phlebotomy' (TAP) for virtually painless whole capillary blood collection using devices incorporating patented technology. This technology eliminates barriers to blood collection by allowing a capillary blood sample to be collected from any physical location without the pain of a fingerstick or the need for traditional phlebotomy. Backed by the latest sciences, data management technology, and certified central laboratories, YourBio Health is seeking to revolutionize and humanize the blood collection process serving clinical trials, and diagnostic and wellness applications.
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SOURCE YourBio Health