VeriPsych is a “Laboratory-Developed Test.” It is an objective blood-based molecular diagnostic tool that relies on a proprietary set of 51 biomarker immunoassays. These biomarkers are associated with specific biochemical pathways, including inflammation, metabolism, and cell-to-cell signaling. The test utilizes a decision rule to evaluate the similarity of a patient’s biomarker pattern to that of medically confirmed schizophrenic patients. It is intended to be used as an aid to the confirmation of the diagnosis of schizophrenia in patients with recent onset of symptoms that do not have co-morbidities such as diabetes, severe inflammation or autoimmune disease.

Federal law allows laboratories to offer Laboratory-Developed Tests without undergoing approval for marketing from the U.S. Food and Drug Administration (FDA). Laboratory-Developed Tests do not require approval for marketing from FDA because they are the activity of a single laboratory, not a traditional device manufacturer, and are not commercially marketed to other labs. These types of tests do go through rigorous validation procedures and must meet several criteria before results can be used for decisions regarding patient care. VeriPsych is a Laboratory-Developed Test.VeriPsych was developed and its performance characteristics were determined by Rules-Based Medicine (RBM). The RBM laboratory is regulated under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high-complexity testing.

A Laboratory-Developed Test (LDT) is a test developed by a single laboratory for use only in that laboratory. LDTs are not distributed or sold as kits to any other labs or health care facilities. Often, a lab will choose to develop and use an LDT because a commercial test is not currently available.

CLIA (Clinical Laboratory Improvement Amendments) is the program used to regulate all laboratory testing performed on humans in the U.S. The objective of CLIA is to ensure quality laboratory testing.CLIA establishes the Centers for Medicare and Medicaid Services (CMS) as the regulatory body responsible for implementing the law. CLIA mandates that laboratories must demonstrate how well an LDT performs using certain performance standards. Examples of such criteria include:

• Accuracy — the ability of a test to most closely measure the “true” value of a substance

• Precision — the reproducibility of a test result

• Test sensitivity — the ability of a test to detect a substance especially at relatively low levels

• Test specificity — the test’s ability to correctly detect or measure only the substance of interest and exclude other substances

RBM is a high-complexity CLIA-certified lab. The VeriPsych test was developed by RBM and is performed by RBM in compliance with CLIA regulations. In addition, RBM holds licenses from states where a license is required except for New York.

Yes. VeriPsych is a Laboratory-Developed Test performed in RBM’s high-complexity CLIA-certified lab. There are many Laboratory-Developed Tests routinely used in clinical practice. Some examples include Pap smears, microbiology cultures and sensitivities, erythrocyte sedimentation rate and genetic tests such as BRCA gene for breast cancer.

VeriPsych is an aid to the confirmation of the diagnosis of schizophrenia and will accompany other tools such as clinical interview, history, and physical exam, and assist you in confirming your diagnosis.

A small proportion of individuals will test in the indeterminate range. If this occurs the psychiatrist may choose to re-test.

The test will be billed to the patient’s insurance provider.

Most ICD coding will fall into 290-298 codes.

CPT codes are listed on the requisition form.

This will depend on the specifics of their insurance policy.

RBM believes it is important for all patients to have access to this test. RBM will consider providing financial assistance to eligible patients.

Please refer to the Protocol for Phlebotomy and Sample Collection document.

RBM will assist you with arrangements for a blood draw by a phlebotomist. RBM will cover phlebotomy charges.

Please see the Protocol for Phlebotomy and Sample Collection document. RBM will cover the FedEx shipping costs.

There is no need to notify RBM regarding a shipment.

You will receive a results report via fax or overnight, certified mail within 1 week after the blood sample is received.

To learn more about VeriPsych, please e-mail us at info@veripsych.com.