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 pose. The 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 FDA, and 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.
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
Our lines of testing
for infectious disease and clinical toxicology
CLEP-approved
FDA-approved
