Curebase has announced a joint clinical trial with start-up Checkable Medical to evaluate the effectiveness of the latter’s at-home test kits for strep throat.
The self-administered test kit includes the strep test, a swab and tongue depressor.
It is paired with a mobile application, which guides home users through the process of taking the necessary sample and interpreting the results.
The app then connects users with a telemedicine provider, who has the ability to prescribe antibiotics to patients that have received a positive result.
The clinical trial’s first stage will take place in four clinical regions, tentatively named as New York, New Jersey, North Dakota and South Carolina.
The clinical trial will confirm the accuracy as well as efficacy of the test kits.
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Initially, the study will include 100 subjects with sore throat symptoms. It will later be expanded to 2,000 participants over the course of the strep season.
Before having a standard of care test at a healthcare facility, the participants of the trial will be given a Checkable Medical at-home strep test kit.
The trial, which will begin next month, will use clinical practices that see walk-in strep patients, including paediatrician offices and urgent care clinics.
For this, Curebase will activate the community-based paediatricians and urgent care facilities.
Checkable Medical founder and CEO Patty Post said: “Instead of arranging an appointment with your doctor for a strep test and then waiting hours or even days to get results back, you’ll be able to pick up our test at a local CVS or Target, use it in the comfort of your own home and get results in ten minutes.
“This helps busy families save time and get results faster while reducing the costs to our healthcare system.”
Upon completion of the clinical trials, the company plans to seek approval from the US Food and Drug Administration (FDA) for its at-home testing device.