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| MDDScore - Depression Blood Test |  |
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Clinician Information
General Information
The MDDScore is a multi-analyte simple blood test that describes a person’s likelihood of having Major Depressive Disorder (MDD). The test was developed, tested, and available through Ridge Diagnostics. Ridge Diagnostics is a diagnostic company with a neuropsychiatric focus. Ridge seeks to apply unique, patented technology using blood-based tests for the diagnosis, treatment selection and monitoring of therapy used in psychiatric disorders. less...
The Science
The science involved in the MDDScore is cutting-edge and constantly evolving. It began with a Human Biomarker Library of approximately 150 biomarkers and a goal to design an accurate diagnostic test for Major Depressive Disorder (MDD) that was a biologic representation of a patient’s state of mind. A review of current biomedical literature to identify candidate biomarkers that were representative of the key biological pathways known to be involved in MDD, helped to narrow the list of potentially useful biomarkers to approximately 50. The blood of healthy “normal” people and the blood of people, who had been diagnosed with MDD, were then analyzed to measure the levels of the 50 markers. Looking for statistically significant differences between blood biomarker levels measured in the “normal” compared to the “MDD”, the list of 50 markers was narrowed to 10. These 10 markers are representative of four biological pathways: HPA Axis, Inflammatory, Neurochemical, and Metabolic. Based upon these findings, a mathematical algorithm was created that could accurately separate the “normal” and “MDD” blood samples, and provide a single composite result from the initial 10 biomarker measurements. The algorithm helps to provide mathematical model stability which improves the accuracy of the test results. The single score is a result that is meaningful and can be easily used in a primary care or specialty setting. less...
Product Description
MDDScore is a multi-analyte immunoassay panel, consisting of ten biological markers selected from Ridge’s Human Biomarker Library. Although each component marker does not have the ability to stand on its own to accurately diagnose Major Depressive Disorder (MDD), each was selected based upon its role in reflecting processes involved in the pathophysiology of depression. The MDDScore is a laboratory test that provides the clinician with a single test result which represents the patient’s likelihood of having MDD. The 10 biomarker serum measurements and the unique algorithm result in the MDDScore. MDDScore’s power resides in the combination of the 10 individual markers and a proprietary mathematical algorithm, that provides an individual result or score that is highly indicative of MDD. The test result is intended to be used as an aid in the diagnosis and management of MDD and in conjunction with other clinical and laboratory information. less...
Utility
The MDDScore is intended to be used as an aid in the diagnosis of Major Depressive Disorder (MDD). It describes the likelihood a person has MDD. While it is not meant to completely replace traditional interview methods, studies have found it to be as or even more sensitive and specific than commonly used assessment tools (ie HAM-D, Beck, PHQ-9). Because the technology is new and different from the tools clinicians have traditionally used to diagnose MDD, prescribing clinicians have found MDDScore utility in many unique and clinically important scenarios.
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How to Order
Complete the patient test requisition form and ask your patient to visit one of the Ridge Diagnostics contracted blood draw facilities. Request the patient visit the lab within 2 days so you will have the test results prior to their next visit (2 weeks). Laboratory draw sites across the country can collect specimens to be shipped for testing at our CLIA certified laboratory in North Carolina. Specimen transportation kits are offered at no charge to ship samples to our laboratory. Specimen transportation kits can be sent to you or your local laboratory. less...
What the "Score" Means
MDDScore describes the likelihood that a person has MDD. Results of the MDDScore are represented by values 1 through 9 with each increasing value considered an increasing likelihood of MDD. For example, a score of 8 is evaluated as 80% likelihood of MDD.
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Cost/Insurance
Most insurance companies reimburse for the test. The list price of the MDDScore is $745. Ridge Diagnostics will bill patient’s medical insurance plans directly. A number of factors affect the amount covered based on a specific insurance plan, co-pay, deductibles etc. If the claim is denied on first review, Ridge can assist in providing any additional information requested as well as help in appealing this denial. In some cases when all appeals are exhausted and the claim is not fully paid, the patient may be responsible for any balances remaining on the invoice. less...
Frequently Asked Questions
What are the biomarkers in the MDDScore? Biomarkers from four key biological pathways that have been implicated in depression comprise the MDDScore. See table below.
Why do I need a test for depression? I have been diagnosing depression throughout my career. We have heard this statement many times. Perhaps a way to think of the MDDScore is from the patient’s perspective. A blood test may provide your patient with biological evidence that can help them to accept and/or understand their diagnosis. It may also help their loved ones accept and support them throughout their therapy. In some cases, patients may have been resistant to the interview or not completely forthcoming with critical information and the availability of a blood test may encourage cooperation. Finally, there are some patients who just do not seem to be getting better on their anti-depressants (estimates are 20%) and a blood test could help you and your patient explore other treatments and diagnoses. How does MDDScore compare to HAM-D, Beck, and PHQ9? The MDDScore is an objective laboratory method to aid in the detection of MDD. HAM-D, Beck, and PHQ9 are interview or subjective paper and pencil screening tools to aid in the detection of MDD. They are meant to be strictly administered and scored according to their respective protocols. Because MDD affects people differently, no assessment method is intended to be used alone. The MDDScore appears to be more sensitive than all three commonly used screening tools. In various studies, MDDScore has a sensitivity of 94% while the HAM-D, Beck, and PHQ9, when administered according to their protocols, have reported sensitivities of 78%, 84%, and 80%, respectively. From various studies, MDDScore specificity of 88% appears to be greater than that of reported study results on the HAM-D (75%) and Beck (82%). The PHQ9 has a range from 72% to 80.0% - cut point of 12. What is the validity and reliability of the MDDScore? The MDDScore is a robust tool to aid in the diagnosis of MDD. MDDScore clinical validity is measured in terms of “sensitivity” and “specificity”. Sensitivity describes the proportion of actual positives which are correctly identified as such (e.g. the percentage of people with MDD who are correctly identified as having the condition). The MDDScore has been shown through studies comparing people with MDD and normal individuals that its sensitivity ranges between 83 and 94%. Specificity describes the proportion of negatives which are correctly identified (e.g. the percentage of healthy people who are correctly identified as not having MDD). The MDDScore has a specificity of 88%. The MDDScore measures 10 blood-based biomarkers using well-established laboratory technology performed in a CLIA certified laboratory. Test reliability refers to the analytical robustness of a test. Each biomarker in the MDDScore panel has been rigorously tested for reproducibility (getting the same answer on standard test samples over and over) and other key analytical parameters. This testing is required before the test can be a CLIA lab service test. What is the PPV/NPV? These are indicators of clinical validity similar to clinical sensitivity and specificity. However, positive predictive value (PPV) and negative predictive value (NPV) are best estimated when the prevalence of the disease or disorder in the study population is known. Positive and negative predictive values can only be estimated using data from a study in which valid disease prevalence estimates are available. This was not a study design used to test the MDDScore. In contrast, sensitivity and specificity can be estimated in studies without knowing the exact disease or disorder prevalence of the study population. Prevalence does not affect the study estimates or calculations of sensitivity or specificity. One type of study design suitable for determining clinical sensitivity and specificity are case-controlled studies. Studies conducted to validate MDDScore were case-control studies, which involve patients with a disease or disorder that, are matched with individuals who do not have the disease (i.e. healthy volunteers). Will MDDScore differentiate MDD from bipolar? MDDScore describes the likelihood that a person has MDD (i.e. a score of 9 indicates a greater than 90% likelihood that the person has MDD; a score of 2 would indicate a less than 20% likelihood of MDD). The “score” as it stands currently helps to “rule-in” or “rule-out” MDD. Creating a biomarker panel to differentiate between unipolar and bipolar depression is under development. Will the test be accurate if the patient is already on an anti-depressant? Yes. The biomarkers are a combination of state and trait markers with the majority being trait. If a patient is currently being successfully treated with an antidepressant, preliminary studies suggest it is likely they will have an MDDScore that is indicative of a higher than normal likelihood of having MDD. Is the MDD Score FDA Approved? MDDScore has met all regulatory requirements to be offered as a laboratory service in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Is Ridge Diagnostics CLIA certified? Ridge Diagnostics laboratory has been certified through CLIA (Clinical Laboratory Improvement Act Amendments) to offer MDDScore as a CLIA lab test service. CLIA’s mandate is to ensure quality laboratory testing. How long does it take to receive my patient’s MDDScore? Ridge Diagnostics will send patient's results to the ordering physician within 7 to 10 business days of specimen receipt. less... |
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