Drawbridge Health recently received 510(k) clearance for a new blood collection system, the OneDraw™ A1C Test System from the U.S. Food and Drug Administration (FDA).
The system is comprised of the OneDraw Blood Collection Device and the OneDraw A1C Test which are intended for the collection of blood and subsequent measurement of HbA1c levels for monitoring the long-term control of blood sugar in people with diabetes.
dLife sat down with Greg Nagy, chief marketing officer at Drawbridge to learn more about the product that aims to revolutionize the way HbA1c testing is done, and what it means at the patient-level.
“The current process of blood collection for testing is an inconvenient, challenging, often painful and overall poor experience for patients and medical providers alike,” says Nagy. “It typically requires a trip to the doctor’s office or a dedicated blood draw center to access a technician specially trained to collect samples.”
Additionally, Nagy states more than 20% of people in the U.S. have an overwhelming fear of needles.
Nagy says the Drawbridge solution is revolutionary because it will provide a comfortable blood draw experience. “That means no painful hypodermic needle which punctures a vein or fingerstick will be required,” he says.
Since the blood draw experience is expected to be more convenient and comfortable than a traditional blood draw, Nagy says it’s also expected to help providers achieve better patient compliance.
Drawbridge Health’s New OneDraw™ A1C Test System. Image courtesy: Drawbridge Health.
How Does the Drawbridge System Work?
Nagy explains blood collection with the OneDraw Blood Collection Device will be an easy process. First a healthcare professional will apply the device to the patient’s upper arm.
He/she will then press two buttons to apply vacuum from the device and activate the lancets starting the blood draw process.
At completion of the blood draw, the healthcare professional will then remove the device from the patient’s skin and the sample cartridge will then be removed from the device for shipment to the certified clinical lab, which will perform the HbA1c testing.
Nagy says because the OneDraw Blood Collection Device integrates draw, collection and sample stabilization into a single easy-to-use device, it can be used by a variety of healthcare professionals, not just by a phlebotomist.
Other key benefits of the system are the following:
· Integrated technology simplifies the collection and preparation of blood samples, enabling blood sampling to take place at other healthcare settings besides labs such as physician’s offices, pharmacies, and clinics.
· Universal solid-state stabilization matrices remove numerous sample prep steps and eliminate the need to manage multiple blood collection tubes.
· A solid collection matrix preserves blood samples and their components in a pristine state regardless of elevated temperatures ensuring accurate, robust testing at a certified clinical laboratory.
When Will the Device be Available?
Drawbridge is currently partnering with leading specialty health and diagnostic testing companies that have a need for simple, convenient access to patient blood samples.
Through the collaboration agreement with Thorne Research, which was announced in 2017, OneDraw will be available to Thorne’s wellness customers in the fourth quarter of 2019.
Will Insurance Cover the Device?
Nagy says insurance coverage for this type of blood draw will depend on the service provider.
OneDraw does not currently have a dedicated CPT code for reimbursement, but in some cases, the insurance coverage will be the same as for standard phlebotomy.
Blood tests are often covered by health insurance for preventive, diagnostic or treatment purposes, but coverage depends on the individual case and the terms of the health insurance plan.
Nagy says if the product is not offered in your local doctor’s offices or diagnostic centers, patients should ask their provider or diagnostic center to contact Drawbridge Health.
“We would love to make OneDraw available to as many patients as possible,” Nagy says.
Drawbridge anticipates the commercial launch of its OneDraw A1C Test System in the fourth quarter of 2019, following FDA clearance that was received on August 15, 2019.
“We envision that in the future, patients will have a choice when it comes to blood collection,” Nagy says, “There is a significant percentage of the population that has a fear of needles and/or the sight of blood and many of these individuals avoid blood tests and are unable to get the proactive healthcare they need.”
He says OneDraw solves this challenge and will provide a choice for patients as it continues to be adopted by healthcare systems and health and wellness providers.
More About Drawbridge Health
Drawbridge Health is a healthcare technology company focused on reinventing the blood sampling paradigm, enabling comfortable and convenient blood sample collection anytime and anywhere.
The company was founded in 2015 by GE Ventures and GE Healthcare.