Tasso earns FDA clearance for its home blood collection device for telehealth tests

Tasso has taken a major step forward in its plans to make quick, easy and widespread blood tests a reality, with an FDA clearance for its simple sample collection device.

The Tasso+ lancet can be placed by the user themselves on their upper arm to fill up a small tube of blood drawn from the capillaries through a push-button suction method the company describes as virtually painless.

Single-use kits can be mailed directly to the patient’s home for self-collection, with samples mailed back to the lab with a prepaid label. This could help provide clinical-grade testing for remote clinical studies run by pharmaceutical companies as well as personal telemedicine appointments.

“With continued industry interest in decentralized clinical trials and diverse testing applications, demand for our high-quality, virtually painless, convenient blood collection solutions is at an all-time high,” CEO Ben Casavant said in a release. “This FDA Class II medical device clearance will help improve patient care by relieving traditional phlebotomy-related bottlenecks and enabling more individuals to get the tests they need at the time they are needed.”

Tasso, a 2021 Fierce Medtech Fierce 15 winner, said it plans to make its Tasso+ available nationwide to pharma companies, healthcare organizations and academic centers by the end of the year. 

The company also makes the Tasso-M20—a device that provides whole dried blood samples and received European approval last year—and the investigational Tasso-SST, which takes samples without adding preservatives to allow for immediate tests of antibodies and other diagnostics.

This past May, Tasso launched a home-testing program aimed at supporting large-scale research into how drugs are processed by the human body. These population-level pharmacokinetic studies can be used by biopharma companies to determine dose sizes and potential side effects. Tasso’s service provides remote dosing, sample analysis and pharmacokinetic modeling.

Prior to that, Tasso teamed up with the telehealth provider Vault Health to help offer siteless clinical trials, remote testing and drug and alcohol screenings for employers.