Behind the Science: How We Prove Our Testing is 99.2% Accurate

When you're making health decisions, you expect the answers you receive to be trustworthy and meaningful. At MicroGenDX, accuracy isn't just a buzzword — it's a cornerstone of our mission.

Whether you're a patient seeking answers or a provider recommending our tests, confidence in our results is key. So, how do we know our testing is 99.2% accurate?

In this blog, we pull back the curtain on the rigorous validation and oversight process that helps MicroGenDX deliver some of the most reliable molecular diagnostics available.

What Does Accuracy Mean Here?

In clinical testing, accuracy refers to how closely our test results match the actual presence or absence of pathogens in a given sample.

This figure reflects the performance of our lab in detecting microbial pathogens using our proprietary combination of qPCR and Next-Gen DNA Sequencing (NGS) technologies.

Our accuracy figure is not self-reported — it is validated through rigorous, third-party evaluations by independent regulatory groups.

One of those groups is the College of American Pathologists (CAP).

What Is CAP and Why Does It Matter?

CAP is a leading organization for laboratory quality assurance in the U.S. and abroad. The validation process conducted by CAP is widely considered the gold standard for medical laboratory accreditation.

A laboratory accreditation from CAP helps clinical labs like ours maintain the accuracy of testing, share best practices, and meet or exceed standards set by federal regulators such as the FDA and OSHA. In many cases, the requirements of CAP are even more strict than federal regulations.

These rigorous assessments ensure that labs maintain high quality and integrity in every step of the process. For patients and providers, a CAP accreditation is visible assurance of trusted results.

What Does the CAP Validation Process Include?

1. Blinded Performance Testing

   CAP sends unknown sample specimens to our lab. We are not told the correct answers ahead of time. These samples mimic real patient specimens and test whether we can accurately identify pathogens. This is one of the most objective ways to verify diagnostic accuracy.

2. On-Site Inspections

   Inspectors from CAP visit our lab to review our operations and quality systems. This includes sample handling procedures, equipment maintenance, chain-of-custody protocols, and staff training. These inspections occur every two years and can be unannounced. CAP uses a checklist with over 500 criteria across areas like molecular pathology and microbiology.

3. Method and Data Review

   CAP reviews both our wet lab and dry lab workflows. This includes our DNA extraction protocols, amplification techniques, internal quality control processes, and data reporting accuracy.

4. Corrective Actions for Nonconformities

   If we fall short on any criteria, CAP requires us to submit a corrective action plan within 30 days. We must explain the root cause, outline the fix, and provide evidence that it worked. Ongoing issues can result in loss of accreditation.

5. Continuous Proficiency Testing and Peer Review

   CAP sends multiple sets of blinded samples throughout the year. We submit our results digitally for review by trained peers at CAP, ensuring consistent performance and accountability.

What Other Standards Does MicroGenDX Meet?

MicroGenDX also complies with the requirements of:

• CLIA (Clinical Laboratory Improvement Amendments)
• New York State Department of Health

CLIA is a federal law that governs clinical labs (except in certain states like New York with their own programs). While CLIA is administered by CMS, CAP performs inspections to ensure compliance.

New York State has some of the strictest standards in the country for lab-developed tests. Requirements include using larger sample sizes, comparing results to other validated methods, and reporting clinical performance metrics such as sensitivity and specificity.

This means we must demonstrate that our test results match those from trusted diagnostic tools under clinical conditions — not just in the lab. MicroGenDX has passed these requirements and meets the high standards of both CAP and New York State.

What Does This Mean for You?

1. High Accuracy = Better Care

   Reliable results mean fewer retests and fewer misdiagnoses. For you, that can mean less trial and error in treatment, fewer doctor visits, and more time and money back in your control.

2. Confidence You Can Trust

   Even if your provider has never heard of MicroGenDX, they can trust our results thanks to oversight from CAP and New York State. This makes providers more likely to rely on our data when treating you.

3. Actionable Insights

   Your report is not just a result — it’s a tool. Our data helps your provider make confident, timely decisions that lead to better outcomes.

Trust Is Built on Process, Not Promises

We understand that diagnostics can sometimes feel like a black box. That’s why we invite expert review of our processes. Third-party validation isn’t just a stamp of approval — it’s our commitment to transparency and clinical excellence.

Quick Recap

• MicroGenDX testing is 99.2% accurate, independently validated
• CAP reviews our performance, operations, and reporting
• New York State adds additional clinical validation requirements
• We meet or exceed both — giving you results you can trust

The Bottom Line

When it comes to your health, you deserve answers that are clear, accurate, and trusted.

Choosing MicroGenDX means choosing a lab that has been tested and validated by experts for over 20 years. Accuracy isn’t a tagline — it’s the foundation of everything we do.

Because when you have health questions, nothing matters more than answers you can rely on.