Here are some common questions we receive about our kits. For more information, please contact us.
FAQ’s
Who is DxTerity? |
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DxTerity Diagnostics is a Los Angeles-based, CLIA-licensed, and CAP-accredited molecular diagnostic clinical lab that specializes in autoimmune disease, infectious disease, and emergency preparedness test development. |
How long has DxTerity been in the life sciences industry? |
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DxTerity was started in 2007 with the goal to advance the understanding, treatment, and management of immune-mediated disease. To that end, DxTerity is committed to providing companies, individuals and researchers with integrated, patient-centric services designed to drive deep discovery and rapid product commercialization. DxTerity’s diagnostic development process provides a full suite of services to advance the next generation of low-cost, high-volume molecular diagnostics. |
What accreditations does DxTerity have? |
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DxTerity operates a state-of-the-art, California State-licensed, College of American Pathologists (CAP) accredited, and Clinical Laboratory Improvement Amendments (CLIA) licensed molecular diagnostic laboratory located in Los Angeles. The lab can perform clinical and pre-clinical studies in compliance with good laboratory practice (GLP) standards. DxTerity is FDA-registered and ISO13485-certified as medical devices (IVDs) manufacturer. |
What is Lupus? |
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Lupus, also called systemic lupus erythematosus or SLE, is a long-term autoimmune disease in which the body’s immune system becomes hyperactive and attacks healthy tissue. Due to its complex nature, lupus is sometimes known as the “disease of a thousand faces.” Inflammation caused by lupus can affect many different body systems — including your joints, skin, kidneys, blood cells, brain, heart, and lungs. |
What is the frequency of Lupus? |
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The frequency of SLE varies by race and ethnicity, with higher rates reported in blacks and Hispanics. In a study of a racially diverse population, the prevalence of SLE was higher in people of color (African American, Asian and Hispanic) than in Caucasians. |
What is IFN-1? |
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Human Type-1 Interferon (IFN-1) proteins are a large group of inflammatory cytokines that help regulate the activity of the immune system. Type-1 Interferon proteins are involved in innate immunity, the body’s first line of defense against viruses. Type-1 Interferon consists predominantly of IFN-α and IFN-β proteins that bind to IFN-α cell receptors. |
What is the value of knowing your IFN-1 score? |
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DxTerity’s IFN-1 test is a qualitative gene expression assay intended to be used in diagnosed Systemic Lupus Erythematosus (SLE) patients to determine IFN-1 Status. Studies suggest that IFN-1 “High” SLE patients are at increased risk of greater disease severity and developing Lupus Nephritis. IFN-1 High SLE patients may be good candidates for IFN-1 lowering drugs, like anifrolumab. Those patients may also be good candidates for participation in a clinical trial. |
How does the DxTerity test work? |
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The DxTerity IFN-1 test measures the expression levels of a panel of IFN-1 stimulated genes using whole blood collected with DxTerity’s patented blood collection tube. The mean expression level of 4 genes is compared to a predetermined threshold and reported as being either IFN-1 Low (Normal) or IFN-1 High. The DxTerity IFN-1 Test is the first and only available IFN-1 gene signature to determine IFN-1 status. |
What does an IFN-1 High score mean? |
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There have been more than 100 studies of IFN-1 in autoimmune diseases, and, in SLE, IFN-1 High patients tend to have the following:
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What percentage of Lupus patients are IFN-1 High? |
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Numerous studies have demonstrated that more than 50% of Lupus patients are IFN-1 High. |
Does a person’s IFN-1 change over time? |
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Numerous studies have demonstrated that, in the absence of an IFN-1 lowering therapy, IFN-1 levels tend to be stable over time. |
What does an IFN-1 Low score mean? |
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There have been more than 100 studies of IFN-1 in autoimmune diseases, and, in Lupus, IFN-1 Low patients tend to have the following:
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What is Lupus Nephritis? |
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Lupus Nephritis is an inflammation of the kidneys caused by Lupus. About 1 out of 2 people with Lupus develop Lupus Nephritis over time. If left untreated, Lupus Nephritis can lead to significant health problems, permanent kidney damage, and even kidney failure. |
What factors can impact your IFN-1 score? |
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Numerous studies have demonstrated that IFN-1 is stable over time and IFN-1 is not impacted by diet or other environmental factors. Therapies used to treat moderate-to-severe Lupus, such as FDA-approved Saphnelo (anifrolumab), inhibit IFN-1 signaling, thereby blocking the biologic activity of IFN-1 genes, reducing their overall level in the body. |
Can I get IFN-1 gene signature testing from Quest or LabCorp? |
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No. The IFN-1 tests offered by Quest and LabCorp are not Lupus-specific gene expression tests. The Quest and LabCorp IFN-1 tests are antiviral, antiparasitic-specific and increased levels suggest recent or ongoing viral or parasitic infection. |
How much blood does the DxTerity IFN-1 test require? |
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The IFN-1 test can be done with either a 1ml blood draw or a fingerstick collected blood sample assisted by a licensed medical professional. |
When can I expect to have my results? |
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Results are typically reported back to the ordering physician within 5-7 business days. |
Is it reimbursable by my insurance? |
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Possibly. Customers will need to contact their insurance provider directly to confirm eligibility based on your insurance type and benefit design. |
Where can I purchase the test? |
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Testing can be ordered by a licensed medical professional. Please contact your physician. |