From point-of-care diagnostic tests to ancestral DNA home-testing, this company’s spit tubes are used by more medical laboratories than any other brand
Most clinical laboratory specialists know that OraSure Technologies of Bethlehem, Pa., was the first company to develop a rapid point-of-care DNA diagnostic test for HIV back in the 1990s. This was a big deal. It meant physicians could test patients during office visits and receive the results while the patients were still in the office. Since many patients fail to follow through on doctors’ test orders, this also meant physicians were diagnosing more patients with HIV than ever before.
Today, OraSure is the dominant company in the spit tube industry. OraSure claims its tubes contain patented chemical preservatives that can maintain the specimen’s integrity for up to two years at room temperature. That’s a long time. And this one feature has made OraSure popular with direct-to-consumer (DTC) genetic home-test developers.
OraSure provides nearly all of the specimen receptacles used by individuals searching for their ancestral roots. It’s estimated that about 90% of the DTC genetic-testing market uses the company’s spit tubes. This is partly because OraSure makes the only tubes approved by the US Food and Drug Administration (FDA) for home DNA-testing purposes.
“The FDA approval gives customers confidence,” Mark Massaro, Managing Director, Senior Equity Analyst at investment bank Canaccord Genuity Group, told Bloomberg. “That, and they can preserve saliva for a long time.”
Spit, Close, Recap, Send
To use the saliva-testing DNA kits, an individual first spits into the tube and then snaps the cap on the tube shut. This action perforates a membrane which contains a patented, chemical mix of preservatives. These chemicals help preserve the sample and minimize contamination from non-human DNA that may be present.
“You’ve got to make it as easy as possible for a person to spit in the tube, close the tube, recap the tube, and send it to you without any variation,” Stephen Tang, PhD, President and Chief Executive Officer at OraSure, told Bloomberg.
Saliva samples are very susceptible to environmental factors like temperature and are extremely time sensitive. They need to be properly handled and stored to prevent any degradation and ensure the most accurate test results. Once in the spit tube, a saliva sample can last more than two years at room temperature, according to the company.
“That’s the secret,” Tang stated. “Saliva is not pure. It’s got a lot of bacteria and other stuff swimming in it.”
OraSure reported the company made $182 million in revenue in 2018, with about $20 million of that amount being profit. DNA Genotek, Inc., a subsidiary of OraSure designed the T-shaped spit tubes being used for consumer-DNA testing kits.
Other Clinical Laboratory Uses for Specimen-Collection Devices
In addition to the consumer-DNA industry, OraSure’s tube technology is used in clinical and academic laboratory situations as well as in veterinary DNA testing. The company is focused on expanding the uses for their specimen-collection technology. They have recently begun using their technology to collect urine specimens for diagnosing sexually transmitted diseases and other conditions. OraSure also has added devices for feces collection, to better compete in the developing field of microbiome for gut bacteria analysis.
“We are all about the integrity of the sample collection,” Tang says. “It’s a wide-open field.”
Ancestry Sued by OraSure
In 2017, Ancestry.com agreed to pay OraSure $12.5 million to settle a lawsuit which alleged the company had copied OraSure’s patented DNA testing technology to produce their own saliva-based DNA test.
According to the lawsuit, Ancestry.com purchased saliva test kits from DNA Genotek in 2012 and 2013 for the purpose of collecting saliva samples from their customers. In 2013, Ancestry.com filed for a patent of their own for an improved variation of the kits reportedly without DNA Genotek’s consent.
OraSure’s test products include:
- An in-home oral HIV test;
- A rapid HIV-1/2 antibody test;
- An HCV rapid antibody test;
- An Ebola rapid antigen test; and
- A nasal test for influenza types A and B.
OraSure also has devices for substance abuse testing, cryosurgical kits for the testing of skin lesions, and kits for forensic toxicology.
Maintaining specimen integrity is critical to ensure lab test results are accurate and reproducible. OraSure’s spit tube technology solves the problem of preserving specimens while they are transported to clinical laboratories and other pathology facilities.