We’ve all read the headlines–a significant obstacle in keeping the coronavirus from spreading has been the shortage of available tests.

In fact, numerous media outlets reported just yesterday that New York could soon “completely run out” of swabs specifically needed for coronavirus testing.

One startup is out to help keep that from happening.

Over the last two weeks, San Francisco-based Origin has quickly shifted its resources from being a 3D printer manufacturer to becoming a medical device manufacturer, and has started production to address the massive shortage of COVID-19 test kits.

Chris Prucha, co-founder and CEO of Origin, told Crunchbase News this afternoon that his company successfully completed a clinical trial of its 3D-printed swab testing kits on April 12.

“We’re now using everything we’d built previously to make these devices,” he said.

A single “Origin One” printer can print up to 1,500 swabs in a single print in under eight hours, according to the company. Plus, the startup claims its test swabs are a more reliable and scalable solution than traditional swab manufacturing.

“Complex, detailed geometries can easily be produced on Origin One and do not require any molds,” the company said in a statement. “The test swabs can be produced when needed, anywhere, with only a single material for the supply chain.”

Before and after

Prior to the COVID-19 pandemic, Origin says it had pioneered the concept of Open Additive Manufacturing, or a new way to build based on open materials, extensible software and modular hardware.

Origin One, the company’s manufacturing-grade 3D printer, uses programmable photopolymerization to precisely control light, heat and force, among other variables, to produce parts. The company worked with a network of partners to develop commercial-grade materials for its system, resulting in what it describes as “some of the toughest and most resilient materials in additive manufacturing.”

But now, manufacturing of that printer is on hold.

“We’re not going to leave our customers out to dry,” Prucha told Crunchbase News. “We’ll continue to support them. But as a startup, it’s hard to have some people work on this new initiative and still work on the regular business. So we’ve decided to focus only on this business as long as it’s needed.”

Origin was founded in 2015 and is led by alumni from Google and Apple (Prucha was a software engineer there). Investors include Floodgate, DCM, Mandra Capital, Haystack, Stanford University and Joe Montana. The company has raised a total of $12.3 million over its lifetime.

Clinical trial success

Origin has been collaborating with Beth Israel Deaconess Medical Center (BIDMC), an academic medical center affiliated with Harvard Medical School, to find a better solution for manufacturing COVID-19 test swabs.

Test swabs are difficult to manufacture and require design features and qualities that include a mix of stiffness and flexibility, biocompatibility, autoclavability, and specimen capture and carrying efficacy, according to Prucha. Traditional test swab production is currently limited to only a couple of factories in the world, he added.

As of April 12, Origin’s new 3D-printed swab passed an initial clinical evaluation for human factors, materials testing and PCR (polymerase chain reaction) compatibility.

“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,” said Ramy Arnaout, MD, ​​DPhil, associate director of the Clinical Microbiology Laboratories at BIDMC, who has led a multidisciplinary effort to resolve the shortage and 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,” he said.

Origin’s test swabs are considered an FDA Class 1 Exempt Device. In addition to BIDMC’s clinical testing, Origin’s swabs have gone through “rigorous testing” with the U.S. Army, Origin material partners, universities including UCLA, and independent medical labs, according to Prucha.

“While successful clinical trials are not required to sell this kind of device, it’s a very strong proof point,” he told Crunchbase News. “We’ve now produced thousands of these devices and are ramping up to produce millions of them in coming weeks as we get more printers online.”

Currently, the company has over 50 printers working on producing swabs.

Looking ahead

Origin designed the swabs using the nTop Platform to rapidly iterate many different versions for BIDMC to evaluate, allowing them to hone in on the best design elements for clinical efficacy and patient comfort. Origin worked closely with its Open Material Network to identify the proper medical grade material and to quickly refine optimal processing conditions.

Origin is also part of a new industry consortium called PrintedSwabs.org, which is bringing together the efforts of the 3D printing industry with academia and medical enterprises to supply millions of 3D printed COVID-19 test swabs.

“We’re not just scaling up, we’re printing them as quickly as we can while having put a process in place to ensure reliability and consistency,” Prucha said.

The company has a partnership in the works to distribute its swabs to the top 50 to 100 health care systems in the world, he told Crunchbase News. For now, health care providers can request information and swabs from Origin’s website.

“The demand has been overwhelming, in the millions without us even publishing the results of our trial,” Prucha said “Specifically, we’ve got demand for more than half a million swabs immediately from a small number of health care providers.”

Ultimately, he expects demand to be “in the tens of millions.”

“We’re going to have to work hard to meet that demand,” Prucha said.