Strep Throat Test with No Wait or Lab Required

What’s causing this terrible sore throat?

What’s causing this terrible sore throat?

That question drives millions of people to doctors, urgent care clinics and emergency rooms each year (PDF). But it’s wasteful to the system, says Bliss Lansing, who founded the startup Health & Bliss Inc., because most sore throats are caused by a viral infection, and symptoms can be addressed with over-the-counter medications. Or, if it’s strep throat, the remedy is simply a prescribed antibiotic.

Instead of going to the doctor, who would likely collect a throat culture and send it to a lab to be tested for strep, or just prescribe an antibiotic anyway, the team at Health & Bliss thinks people should go to a pharmacy or clinic.

The emergence of rapid strep testing kits has started that movement. MinuteClinic, for instance, lists a quick strep test for $27 on its website. Lansing said these quick tests can analyze throat swabs in 10 to 15 minutes and are much more efficient that the gold standard throat culture that needs to be sent to a lab. But they still require quite a bit of hands-on time for the care provider, because they contain test trips, chemicals, plastic tubes and cardboard holders.

Her startup’s Strep Test Anywhere has turned that same science into a convenient, self-contained test. “We’ve removed the need to perform the test in a lab with a built-in lab environment that eliminates the risk for cross-contamination,” she said. “The hands-on time for the physician is under 30 seconds.”

That’s a valuable proposition for patients, providers, and payers, she explained. First, it would allow patients to skip going to a primary care provider and opt for a clinic or pharmacy instead, where they would pay out-of-pocket for the test. It’s priced to be comparable to the average co-pay — around $30, Lansing said. In the wake of a primary care shortage, providers would probably like that idea, too.

Payers would like it, too, because it would result in fewer claims and could eliminate costs associated with unnecessary doctor visits and unnecessary antibiotic prescriptions, she said.

The company has collected pre-clinical lab data on its test and is now working on developing clinical protocols. The next step, Lansing said, is completing a 510(k) application and performing a clinical trial to evaluate the test’s sensitivity and specificity.

As the company looks toward a Series A to fund that trial, Lansing said she thinks the company will be intriguing to investors. “Not many medical device VCs get the opportunity to work with a retail product,” she explained. “We’re a retail medical device that is out-of-pocket, which is a unique proposition. We really see the public and providers and payers understanding the vision.”

Lansing got the idea for the test when she was doing research on corporate wellness as part of her master’s program in exercise science. The company is now part of the ZeroTo510 medical device accelerator in Memphis and is preparing for demo day on August 8.

Originally published on MedCityNews.com.