Research

Research In Clinical Trials, R&D and Data

Few decisions will affect your clinical trial more than your choice of a lab. We believe a lab for clinical trials should go beyond simply helping you to complete your study as envisioned.

Our full-service clinical laboratory includes clinical and research as well as full project management, data management, and logistics to support studies.

We can provide a unique combination of CLIA-approved clinical trials with a high throughput clinical laboratory as part of a comprehensive plan. Our SOPs and scientific oversight ensure accurate and timely results.

We have an advanced staff of scientists to understand the needs of your trials and will work with you to optimize your plans

Our focus is on advanced Molecular Diagnostics. Our Target Sequencing Platforms allow the most sensitive results down to a very small amount of sample present. We also utilize over 5 genetic testing platforms for diversity of sampling.

With one of the lowest cost structures in the industry and access to patient samples, our R&D platform can support even the most technical research required by our customers.

Give us a call today so we can better understand your needs and we can build a comprehensive strategy together.

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Referenced from https://www.cms.gov/regulations-and-guidance/legislation/clia

How does CLIA define a “laboratory”?

The CLIA regulations define a laboratory to be “a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body” (42 C.F.R. § 493.2 (definition of “laboratory”).

How does the Centers for Medicare & Medicaid Services (CMS) determine CLIA applicability?

CLIA applicability is determined using the regulatory definition of “laboratory” quoted above. Specifically, CLIA applies when: (1) patient-specific results are reported from the laboratory to another entity; AND (2) the results are made available “for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.” As stated above, whether a test service is billed to Medicare has no bearing on CLIA applicability. Therefore, if a facility performs tests for the above-stated purposes, it is considered a laboratory under CLIA and must obtain a certificate from the CLIA program that corresponds to the highest complexity of tests performed.

What facilities need to have a CLIA certificate?

CLIA requires all facilities that perform even one test, including waived tests, on “materials derived from the human body for the purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” to obtain a CLIA certificate and meet CLIA regulatory requirements. Facilities that only perform testing for forensic purposes are excepted from the CLIA regulatory scheme.

Depending on the circumstances, research testing can be either excepted from CLIA or subject to CLIA. Specifically, testing facilities may qualify to be excepted from CLIA certification if they meet the description of “research laboratories” provided by the CLIA regulations at 42 C.F.R. § 493.3(b)(2). In accordance with that regulation, only those facilities performing research testing on human specimens that do not report patient-specific results may qualify to be excepted from CLIA certification. An example of a non-patient-specific result would be “10 out of 30 participants were positive for gene X.” The result in this example is a summary of the group data, and is not indicative of an individual’s health. An example of a patient-specific result would be “participant A was positive for gene X” in which the result is specific to participant A.

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What types of research testing are subject to CLIA?

In most cases, research testing where patient-specific results are reported from the laboratory, and those results will be or could be used “for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings” are presumed to be subject to CLIA absent evidence to the contrary.

In cases where patient-specific test results are maintained by a statistical research center for possible use by investigators in which the results are not reported out as patient-specific and could not be used “for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings,” CLIA would not apply.

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