US-based clinical-grade blood collection solutions provider Tasso has received a CE mark for its new high-volume liquid blood collection device, TassoOne Plus.
TassoOne Plus is the latest addition to the company’s portfolio of CE mark-approved blood collection solutions for dried and liquid samples.
The device enables the users to collect their own blood through an easy and virtually painless process, which can be completed at home.
Tasso said that the sample collection process using TassoOne Plus provides high volumes and superior sample quality compared to traditional remote blood sampling techniques.
Also, the samples can be used with existing downstream analysis workflows of pharmaceutical companies, healthcare organisations, and academic institutions across Europe, said the company.
Tasso CEO and co-founder Ben Casavant said: “The demand for convenient, patient-centric care is exploding, and Tasso is on a mission to bring high-quality healthcare into homes worldwide.
“This CE mark unlocks clinical-grade liquid blood collection for decentralised clinical trials and home healthcare within the European Union, accelerating and expanding access to care. Regulatory clearances like this one are a testament to the quality and safety of our products.”
According to the company, TassoOne Plus meets all the performance, safety, and relevant product requirements under the new European Union Medical Device Regulation.
With the CE mark approval, the company now expands its patient-centric, high-volume blood collection solutions offering for the European market.
In December 2021, Tasso secured $100m in a Series B financing round led by RA Capital Management, which increases the company’s total capital raise to $131m.
The funding round saw participation from new investors the D.E. Shaw group, Senvest, InCube, and SVB Innovation Fund, alongside existing investors Foresite Capital, Hambrecht Ducera Growth Ventures, J2V, Cedars-Sinai, and Merck GHIF.
Tasso intended to use the funding to scale its manufacturing and operations to meet the increased demand for its blood collection devices and decentralised health testing services.
In September last year, Tasso received the US Food and Drug Administration (FDA) approval for its Tasso+ lancet as a Class II medical device.
