For Healthcare Professionals

Bringing Strep Testing Closer to the Patient

Checkable is developing an over-the-counter rapid strep test designed to help patients get an initial answer in about 10 minutes at home. At-home strep testing has the potential to help reduce unnecessary clinic and urgent care visits by giving symptomatic individuals access to an initial testing option at home — while keeping care decisions in your hands. The product is not yet FDA authorized.

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~10 minute results
Rapid antigen immunoassay
Designed for home use
Talking to a patient during a consultation

Clinical Context

The First Mile of Care Is Where Time Is Lost

Sore throat is one of the most common reasons for outpatient visits. Many patients arrive at a clinic or urgent care only to learn their symptoms are viral — while others wait for a result that an initial at-home test could potentially help inform sooner.

36M

Annual visits

US healthcare visits each year involve testing for strep throat.

5.2M

Positive cases

Only a fraction of those tested are ultimately diagnosed with strep.

Hours

Spent waiting

Time away from work, school, and your exam room for a single answer.

Resources

Clinical Research & Resources

Explore research on home-based strep testing and its potential role in supporting primary care.

Female doctor in blue gloves swabs a patient's throat during a medical exam in a clinic. This image shows healthcare in action, emphasizing the importance of thorough checkups PDF

Research Poster

Westwood/Mansfield Pediatrics
Westwood, Massachusetts

Featured Resource
Independent Research

Building Capacity for the Medical Home

Managing Acute and Chronic Conditions in the Primary Care Setting

This pediatric practice pilot explored whether parent-administered rapid strep testing could reduce nonurgent sore-throat visits and create additional capacity for chronic care management.

27.5% reduction in in-office strep testing at the pilot site during the study period.

Download Research Poster (PDF)

This is independent, historical practice-based research conducted by Westwood/Mansfield Pediatrics. It is not a clinical study of Checkable's Home Strep Test and did not evaluate Checkable's product. Findings are specific to the study setting and should not be interpreted as evidence of Checkable's clinical performance, healthcare utilization impact, or expected results.

Regulatory Status

Where We Are in the Process

Transparency matters to the clinicians who may one day recommend Checkable to their patients. Here is exactly where the product stands today.

Complete

Development & Design Validation

Assay design, usability testing, and manufacturing process development.

In Progress

FDA Review — De Novo Classification

Checkable's Home Strep Test is currently under FDA review through the De Novo classification process. The product has not yet received FDA marketing authorization.

Planned

Retail Availability

Future retail availability would follow FDA marketing authorization. No authorization date has been established.

Important: Checkable's Home Strep Test is currently under FDA review through the De Novo classification process. The product has not yet received FDA marketing authorization and is not currently available for sale. Nothing on this page is intended as medical advice, as a claim of diagnostic accuracy, or as a representation that FDA authorization will be granted. No authorization date has been established.

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