Type I Interferon (IFN-1) for SLE
IFN-1 is a key prognostic indicator for the risk of SLE patients developing lupus nephritis2
Type I Interferon (IFN-1) activity is central to how your body defends itself against viruses and pathogens, however persistent over activity has been shown to play a central role in systemic lupus erythematosus (SLE) disease development and progression1. It is estimated that more than 50% of SLE patients with moderate to severe disease over express IFN-1, and this over expression has been linked to increased disease severity5,6,11. DxTerity's IFN-1 test has been shown to be a key prognostic marker for SLE patients developing lupus nephritis (p = 0.0008)4. The IFN-1 immune pathway is also a common therapeutic target13,14 and the DxTerity IFN-1 test is being used for therapeutic clinical trial enrollment and monitoring.
Description of the IFN-1 Test
The IFN-1 test measures the relative expression of 4 mRNAs associated with Type I Interferon activity. These mRNA results are used to calculate an IFN-1 score, which is evaluated against an established threshold to determine if a patient is Interferon High or Interferon Normal (Low). This qualitative IFN-1 assay is to be used in conjunction with clinical assessment and other laboratory tests.
IFN Type I Clinical Uses
DxTerity IFN-1 Test uses Chemical Ligation Dependent Probe Amplification (CLPA) technology and is performed directly on PAXgene® or DxCollect® stabilized whole blood. The gene expression is are analyzed by capillary electrophoresis and the IFN-1 level is calculated relative to the average of three control genes. Below are the sample collection methods used for the IFN-I test.
DxTerity DxCollect MCD
Size: 16x100 mm
Tube Material Plastic
Draw Volume 100 uL
Regulatory Status IUO
PAXgene® Blood RNA Tube
Size: 16x100 mm
Tube Material: Plastic
Draw Volume 2.5 mL
Regulatory Status IVD
DxTerity IFN-1 Test
The DxTerity IFN-1 Test is a qualitative gene expression assay for determining if an SLE patient has High or Normal (Low) Type I Interferon activity.
1Crow MK, Type 1 Interferon in the Pathogenesis of Lupus, The Journal of Immunology. 192(12); 5459-5468 (2014)
2Arriens C et al, Increased Risk of Progression to Lupus Nephritis for Lupus Patients with Elevated Interferon Signature[abstract], Arthritis Rheumatol. 2019; 71 (suppl 10) https://acrabstracts.org/abstract/increasedrisk-of-progression-to-lupus-nephritis-for-lupus-patients-with-elevated-interferon-signature/
3Barber et al, Economic evaluation of lupus nephritis in the Systemic Lupus International Collaborating Clinics inception cohort using a multistate model approach, Arthritis Care Res, 2018 70(9):1294-1302
4Arriens C et al, Increased Risk of Progression to Lupus Nephritis for Lupus Patients with Elevated Interferon Signature, Arthritis Rheumatol. 2019; 71 (suppl 10) https://acrabstracts.org/abstract/increasedrisk-of-progression-to-lupus-nephritis-for-lupus-patients-with-elevated-interferon-signature/
5X. Feng and et al., "Association of increased interferon-inducible gene expression with disease activity and lupus nephritis in patients with systemic lupus erythematosus.," Arthritis Rheum., pp. Sep;54(9):2951-62., (2006)
6Kirou KA et al, Activation of the Interferon-α pathway identifies a subgroup of Systemic lupus erythematous patients with distinct Serologic Features and active disease, Arthritis Rheum 52:1491–503 (2005)
7Clowse MEB et al, A national Study of Complications of Lupus in Pregnancy, Am. J. Obstet Gynecol, 199(2):127.e1-127e6 (2008)
8Andrade D et al, Interferon-α and Angiogenic Dysregulation in Pregnant Lupus Patients Who Develop Preeclampsia, 67(4): 977-987 (2015)
9Niewold TB et al, High serum IFN-α activity is a heritable risk factor for systemic lupus erythematous, Genes Immun. 8(6):492-502 (2007)
10Petri M et al, Longitudinal Expression of type 1 interferon responsive genes in systemic lupus erythematous, Lupus 18(11):980-989 (2009)
11E. Baechler and et al., "Interferon-inducible gene expression signature in peripheral blood cells of patients with severe lupus.," Proc Natl Acad Sci U S A., pp. Mar 4;100(5):2610-5. Epub 2003 Feb 25., (2003)
12Kirou KA et al, Activation of the Interferon-α pathway identifies a subgroup of Systemic lupus erythematous patients with distinct Serologic Features and active disease, Arthritis Rheum 52:1491–503 (2005)
13Lauwerys BR et al, Type 1 interferon blockade in systemic lupus erythematosus: where do we stand?, Rheumatology, 53:1369-1376 (2014)
14AstraZeneca Press Release 08-29-19, Anifrolumab Phase III trial meets primary endpoint in systemic lupus erythematous: https://www.astrazeneca.com/media-centre/press-releases/2019/anifrolumab-phase-iii-trial-meets-primary-endpoint-in-systemic-lupus-erythematosus-29082019.html
This Test was developed and its performance characteristics determined by DxTerity Diagnostics Inc. DxTerity has established its accuracy and precision pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88). This Assay has not been cleared or approved by the US Food and Drug Administration. The FDA has determined that such clearance and approval is not necessary. This laboratory is regulated under the Clinical Laboratory Improvements Amendments 1988 (CLIA-88) as qualified to perform high complexity clinical testing. This assay is used for clinical purposes and should be interpreted in reference to other laboratory and clinical findings.
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Our clinical diagnostic laboratory is College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified licensed.