"The quality and performance of a laboratory test is a matter of vital concern.
CLEP approval represents accuracy that every physician should demand of laboratory tests,
without compromise."

Laboratory-developed tests approved by CLEP

High-quality testing leads to high-quality patient outcomes

Newer diagnostic testing developed with advanced science and technology provides greater accuracy, facilitating better patient care. Yet with tens of thousands of laboratory-developed tests (LDTs) available, the risk of inadequate test performance can contribute to improper patient diagnosis and treatment, directly affecting patient outcomes.

 

With limited oversight prior to availability for use, LDTs are excluded from regulatory requirements and have been for over 40 years, reflecting the risks these tests can poseThe FDA has identified problems with several LDTs that put patients at risk of receiving delayed or unnecessary treatment or not receiving any treatment.

Testing is the first step toward healing, and when it comes to patient health and safety,
the quality of diagnostic testing is not a compromise to make.

As a specialized medical laboratory, we know clinicians require reliable and accurate testing to confidently determine the best course of treatment. That is why Acutis Diagnostics is part of less than 1% of labs in the United States providing laboratory-developed testing approved by CLEP, a third-party reviewer for the FDAand a division of the New York Department of Health (NYSDOH). CLEP – the Clinical Laboratory Evaluation Program – oversees laboratory-developed tests to ensure accuracy and reliability.

 

For an LDT to meet CLEP standards, it is put through significantly more rigorous validation measures and reviews than other LDTs over an extended period of time. Most significantly, all of this is executed before it’s approved for patient use, ensuring the highest quality LDT testing in the country.

We’ve seen first-hand that our partner physicians see better patient outcomes
when using the most advanced science and testing that Acutis offers.


Our CLEP-approved tests meet stringent review standards and demonstrate clinical validity
before they are authorized for patient use, enabling our practitioners to diagnose
and treat patients with greater certainty and ease.

Science Lab

Approval processes for a new laboratory-developed test

Test with CLEP approval

6 - 12 month duration

External review of validation led by scientific board of industry-leading experts from CLEP

Scientific board review of operating procedures for performing the test

Review of proficiency tests

Approval of director qualifications

CLEP approval
guarantees accuracy and quality

Test without CLEP approval

Immediate

Reviewed only
by internal lab team
without any external review
prior to test being offered

Internal approval
with no guarantee of performance

Test is available for patient use

acutis-website-source-main-REVEAL-2.jpeg

Our lines of testing
for infectious disease and clinical toxicology

CLEP-approved

FDA-approved

Choose the highest degree of certainty when you choose Acutis. 

If you are interested in learning more about the importance of CLEP approval for laboratory-developed tests, or our infectious disease or clinical toxicology testing, contact us today.