Vitestro launches world’s largest clinical trial for autonomous blood collection 

Credit: Shutterstock/ lianleonte

Vitestro BV has launched the ADOPT (Autonomous Blood Drawing Optimization and Performance Testing) trial for its autonomous blood technology. ‘This study is expected to include over 10,000 patients and represents the most extensive investigation worldwide of autonomous blood collection to date’, Toon Overbeeke, CEO and co-founder of Vitestro, told Medical Device Network.  

Founded in 2017 in Utrecht, the Netherlands-based Vitestro is developing a new platform to improve the blood drawing experience. Blood draws are performed around 10 billion times per year worldwide, and play a pivotal role in clinical diagnostics. Manual venepuncture using vacuum tubes is the primary conventional method. However, blood collection is a labour-intensive process, and staffing shortages of personnel such as nurses, lab technicians and physicians present a problem for clinical laboratories. In addition, even for experienced phlebotomists, ‘the manual venepuncture failure rates are 3% to 7%’, said Brian Joseph, Vitestro co-founder and commercial director. 

According to a collective paper published in Clinical Chemistry and Laboratory Medicine, pre-analytical errors account for up to 70% of all laboratory testing errors. The most common pre-analytical error is sample haemolysis, which affects up to 3.8% of the samples tested, depending on how well the laboratory performs. 

Vitestro co-founders Overbeeke and Joseph have devised a hybrid platform to automate the pre-analytical phase using artificial intelligence and robotics to enhance standardisation and reduce reliance on skilled personnel. 

The Vitestro team is partnering with OLVG Lab and Amsterdam University Medical Centers in the north of the Netherlands, the Utrecht-based St. Antonius Hospital, and Result Laboratorium at the Albert Schweitzer Hospital in Dordrecht in the south-west Netherlands. The blood drawing device combines artificial intelligence, ultrasound-guided 3D reconstruction and robotic insertion with laboratory automation technology.  

The device integrates different technical modules to enable a fully automated blood draw. This includes imaging (3D vein detection) and robotic needle insertion, handling and filling blood sampling tubes, and ‘application of a bandage and an automated tourniquet system’, said Joseph.  

The robotic system also includes a user interface, which can be accessed both by patients, and a device supervisor such as a nurse or lab technician. A trained healthcare professional can supervise multiple devices simultaneously. ‘This new venepuncture technology is suitable for patients aged 16 years and older, including those with comorbidities and/or known difficult venous access’, said Overbeeke. 

The platform was unveiled in 2022 at the annual meeting of the Netherlands Society for Clinical Chemistry and Laboratory Medicine (NVKC) on May 31 in Rotterdam. An initial prototype has been tested in 1,500 patients, with 1,500 autonomous punctures and 2,000 blood samples analysed.  

The ADOPT study, which has just been launched, will begin with 350 patients initially, but is eventually expected to enrol a total of 13,618 children, adults and older adults aged 16 years and older across 4 hospital centres in the Netherlands. The purpose of this pre-market clinical study is to evaluate the performance (efficacy) and safety of the autonomous venepuncture device.

The study consists of 6 phases, including 4 exploratory studies to further improve and test the technology and usability of the device. The second phase is a confirmatory, pivotal clinical study, required for regulatory approval, designed to demonstrate non-inferiority compared to manual blood drawing. ‘We expect to obtain CE marking by the end of 2024 and thus anticipate market introduction in the EU the same year’, said Joseph.  

In 2023, Vitestro expanded its workforce by 33%. The Dutch medtech company, which raised $12.7 million in a Series A round in March 2023, has its sights set on a global market that its internal market research estimates at €20 billion to €30 billion. ‘The CAGR is 4% to 10% per year depending on the region, preventive testing and aging’, said Joseph. 

Vitestro is up against significant competition, with half a dozen US medtech companies currently developing either suction techniques utilising a vacuum chamber, motion sensor techniques coupled with microfluidics, or ultrasound techniques for precise vein location and needle insertion. ‘Our cutting-edge autonomous technology, which eliminates the need for manual vein marking, sets us apart’, said Joseph.