San Franciso startup Origin is the latest company to reveal it has been working on 3D printed nasal swabs for COVID-19 testing. The company recently announced that its 3D printed swab design successfully underwent an initial clinical evaluation for human factors, materials testing and PCR compatibility. The evaluation is being done in collaboration with the Beth Israel Deaconess Medical Center (BIDMC), which is also working with a handful of other 3D printing companies in the development and deployment of 3D printed test swabs.
In the fight against COVID-19 there are many uncertainties. One thing that most countries can agree on, however, is that widespread testing is a vital part of understanding and mitigating the spread of the virus. Despite this, the scaling up of testing processes has encountered hurdles across the U.S. and the world for several reasons, one of which is a lack of testing supplies like nasopharyngeal swabs. To address this shortage, we have seen a number of 3D printing companies step up to develop viable testing swabs which could be mass produced using AM.
The swabs themselves must meet certain standards. From a mechanical perspective, they must be both stiff and flexible enough to be inserted into the nasal cavity and moved around, and they also have to be biocompatible and effective at capturing and containing specimens. Additive design and production have presented themselves as a suitable solution for the development of swabs that meet these criteria. Origin, which has brought to market the Origin One open AM platform, designed its swab using nTopology’s nTop Platform and has been working with BIDMC to test and trial the device for efficacy and safety. Initial tests showed promise for the 3D printed swab and Origin says it expects the full results of the clinical trial will be ready to publish soon.
“The nation’s need for rapid and widespread testing for COVID-19 has been hampered by a widespread shortage of the swabs needed for testing,” commented Ramy Arnaout, MD, DPhil, Associate Director of the Clinical Microbiology Laboratories at BIDMC, who is overseeing the clinical evaluations of 3D printed swabs at BIDMC. “Innovations in 3D printing hold real promise for our collective efforts to diagnose and treat COVID-19, as well as to flatten the transmission curve.”
The swab, considered an FDA Class 1 Exempt Device, is designed to be printed using the Origin One system, which can reportedly print up to 1,500 swabs in under eight hours. The test swabs have also undergone testing with the U.S. Army, Origin material partners, universities such as UCLA and independent medical labs.
“Origin is proud to join together with teams of experts across technology, healthcare and academia to help fast-track efforts to get durable and safe medical devices in the hands of healthcare professionals,” added Chris Prucha, Co-Founder and CEO of Origin. “These are unprecedented times that require unprecedented measures. Given this, Origin has made the decision to focus its efforts solely on developing medical devices and PPE during this crisis. This shift happened quickly and under very difficult conditions, as San Francisco was the first city to order shelter in place. We are pleased to say that the clinical trial results of our test swabs have gone very well and the positive feedback has enabled us to develop a more comfortable product for patients.”
Origin is part of a consortium across AM, academia and medical whose goal is to develop 3D printed testing swabs. The effort includes Formlabs, Carbon, EnvisionTEC, Desktop Metal and Origin on the AM side and BIDMC, the Harvard John A. Paulson School of Engineering and Applied Sciences, USF Health, Resolution Medical, Ohio State and others. Through the consortium, validated manufacturers across the United States are now printing up to 4 million test swabs per week. Read more for an in depth look at how additive manufacturing is playing a role in nasal swab development.