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Large-Scale Surveillance Study Confirms Reliability of the OneDraw™ Blood Collection Device In Remote Blood Sample Collection at Home
News provided byThorne HealthTech, Inc.
May 11, 2022, 4:15 PM ET
In a major research study, 4,000 participants collected their own blood samples to test for COVID-19 antibodies; 99.9% of samples received successfully processed
NEW YORK, May 11, 2022 /PRNewswire/ -- Thorne HealthTech, Inc. ("Thorne HealthTech" or "Thorne") (NASDAQ: THRN), a leader in developing innovative solutions for a personalized approach to health and well-being and majority owner of Drawbridge Health, shared the results of a large-scale surveillance study conducted by the Medical Research Council (MRC) Epidemiology Unit, University of Cambridge, to assess the prevalence of previous infection with COVID-19 using remote blood samples collected with the novel patient-administered OneDraw™ Blood Collection Device. In addition to the ease of self-administration and near-pain-free experience for the user, 99.9% of the samples taken with the OneDraw device received by the laboratory were successfully processed, demonstrating the reliability of this approach in remote collection of blood samples.
Over the 12-month study period, 4,000 U.K. participants collected a total of more than 10,000 blood samples remotely for repeated COVID-19 serologic testing. In the device feasibility study of 21 participants, participant acceptability was high, with 76% of participants preferring the OneDraw device over other blood collection methods. The study results were published in the Journal of Telemedicine and Telecare on May 10, 2022.
"We are pleased with the results of this study, as the ability for participants to collect their own blood samples remotely without guidance from a healthcare practitioner and no specialized training is essential to the future growth of telehealth," said Co-CEO of Drawbridge Health, Jerome Scelza. "The pandemic has shed light on the power of telehealth, and this study further shows the importance of both patients and the public having access to high-quality testing and care on their own schedule. OneDraw has the potential to greatly advance the ability of individuals to easily, reliably, and conveniently collect blood samples remotely for a variety of laboratory tests."
In the study, the OneDraw Blood Collection Device was placed on the lateral upper arm or thigh and 150 µL of blood was collected onto two volumetrically controlled matrices in a removable cartridge. Unlike traditional blood sampling, or even other at-home blood-sampling methods, the OneDraw samples can be stored at room temperature for up to 28 days through proprietary cold-chain free-storage technology, making it ideal for patients or research participants in remote areas or for a multi-site clinical trial. The OneDraw device is already cleared by the FDA as a Class II medical device and has a CE (European Conformity) mark for the supervised use by health-care professionals to collect blood samples for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in individuals with diabetes.
"Even before the pandemic, individuals were reluctant to go to a doctor's office for a blood sample – be it a fear of needles, a busy schedule, or a lack of transportation," said Paul Jacobson, CEO of Thorne HealthTech. "OneDraw removes the obstacles preventing individuals from taking better control of their health, ultimately offering an improved experience. Those who use OneDraw report significantly less pain and greater ease of capturing a high-quality blood sample. At Thorne HealthTech, we are committed to creating a better consumer experience through our data-driven approach to personalized health and wellness tests and solutions."
"The OneDraw device allowed us to conduct population-based studies remotely during the pandemic at a time when blood sample collection by trained health-care workers was not possible," said Dr. Kirsten Rennie at the MRC Epidemiology Unit. "This technology could increase the reach of health research studies in the future, making participation more accessible to those who previously would have been difficult to recruit and those who might struggle to attend an in-person clinic visit."
Building off the success of this trial, Thorne HealthTech is currently studying additional applications of the OneDraw device, including the use of its new plasma separation cartridge, which will expand Thorne HealthTech's portfolio of lab tests, while preserving convenient sample transport. Long term, Thorne HealthTech anticipates the device will contribute to its core focus in healthy aging, longevity, and precision wellness by working with lab partners to develop the next generation of blood tests. Thorne also plans to pilot the OneDraw device in its new Thorne Lab clinic.
About the study
The development, validation and application of remote blood sample collection in telehealth programmes trial enrolled 4,000 participants who used 12,000 OneDraw devices to collect at-home blood samples. It tested: (1) feasibility of participants using the device at-home with minimal instruction by the study investigator on upper arm and thigh sites (2) stability of the dried blood sample collected remotely (3) participant acceptability of the device compared with finger-prick and venous blood samples and the validity of SARS-CoV-2 virus antibody measurement versus venous blood sample (4) application to the Fenland-COVID19 study in 4,023 participants at 3 timepoints across 6-months. Participant acceptability was high, with a significantly lower median perceived pain score and 76% preferring the OneDraw device over the other blood collection methods. There was high level of agreement in SARS-CoV-2 virus antibody results with venous blood samples in 120 participants (Cohen's kappa 0.68 (95% CI 0.56, 0.83). In Fenland COVID-19 study, 92% of participants returned a sample at baseline (3,702/4,023), 89% at 3 months (3,492/3,918) and 93% at 6 months (3,453/3,731), with almost all samples received successfully processed (99.9%).
Forward Looking Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this news release, including, without limitation, statements regarding the conditions of our industry, business strategy, development plans, regulatory strategy, product and service development, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. These forward-looking statements are current only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions described in the section titled "Risk Factors" and elsewhere in Thorne HealthTech's filings made with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed with the SEC on March 16, 2022, and other SEC filings, copies of which are available free of charge on the SEC website at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.
About Thorne HealthTech:
Thorne HealthTech is a leader in developing innovative solutions for delivering personalized approaches to health and well-being. As a science-driven wellness company that empowers individuals with the support, education, and solutions they need to achieve healthy aging – living healthier for longer – Thorne utilizes testing and data to create improved product efficacy and to deliver personalized solutions to consumers, health professionals, and corporations. Predicated on the power of the individual, Thorne leverages artificial intelligence models to provide insights and personalized data, products, and services that help individuals take a proactive and actionable approach to improve and maintain their health over a lifetime. Thorne is the only supplement manufacturer that collaborates with Mayo Clinic on wellness research and content and is trusted by more than four million customers, 45,000 health professionals, thousands of professional athletes, more than 100 professional sports teams, and 12 U.S. National teams. For more information, visit Thorne.com.
About Drawbridge Health
Drawbridge Health is a healthcare technology company focused on reinventing the blood draw experience, enabling comfortable convenient blood sample collection anytime and anywhere. By integrating engineering, chemistries and modular design, Drawbridge Health has developed a people-friendly system for collecting and stabilizing blood samples, opening new doors to enable access to important health information. For more information, please visit www.drawbridgehealth.com.
Medical Research Council Epidemiology Unit
The MRC Epidemiology Unit is a department at the University of Cambridge. It is working to improve the health of people in the UK and around the world. Obesity, type 2 diabetes and related metabolic disorders present a major and growing global public health challenge. These disorders result from a complex interplay between genetic, developmental, behavioural and environmental factors that operate throughout life. The mission of the Unit is to investigate the individual and combined effects of these factors and to develop and evaluate strategies to prevent these diseases and their consequences. www.mrc-epid.cam.ac.uk The Fenland COVID-19 study is funded by the UK Medical Research Council (MRC). Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers' money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation. https://mrc.ukri.org/
About the University of Cambridge
The mission of the University of Cambridge is to contribute to society through the pursuit of education, learning and research at the highest international levels of excellence. To date, 109 affiliates of the University have won the Nobel Prize. Founded in 1209, the University comprises 31 autonomous Colleges and 150 departments, faculties and institutions. Cambridge is a global university. Its 19,000 student body includes 3,700 international students from 120 countries. Cambridge researchers collaborate with colleagues worldwide, and the University has established larger-scale partnerships in Asia, Africa and America. The University sits at the heart of the 'Cambridge cluster', which employs more than 61,000 people and has in excess of £15 billion in turnover generated annually by the 5,000 knowledge-intensive firms in and around the city. The city publishes 316 patents per 100,000 residents. www.cam.ac.uk
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SOURCE Thorne HealthTech, Inc.