Veena Joy, MS: FDA Approves Thermo Scientific’s EliA SmDP-S Test for Lupus

Rheumatology Network interviewed Rheumatology Network interviewed Veena Joy, MS and PhD candidate, to discuss Thermo Scientific’s recent FDA approval of their EliA SmDP-S test, which aides in the diagnosis of Systemic Lupus Erythematosus (SLE). She explains why diagnosing autoimmune diseases is so challenging, how the test aides in diagnosing SLE, and how it helps to improve outcomes in this patient population.

Rheumatology Network: To begin, what makes diagnosing autoimmune disease so challenging?

Veena Joy, MS: Well, diagnosing autoimmune diseases is challenging because there are many different types of autoimmune diseases with multiple different markers. So, clinicians have to take all of those aspects, both from a laboratory and a clinical perspective, into consideration when being able to identify and pinpoint the 1 specific disease that could be causing a patient their symptoms.

RN: Can you tell me a little bit about the test and how it helps diagnose lupus?

VJ: Absolutely. The Thermo Scientific EliA SmDP-S differentiates systemic lupus erythematosus, or SLE, from mixed connective tissue disease and provides clinicians really a greater diagnostic confidence. With that greater diagnostic confidence, you have the potential improvement for outcomes and treatment for these patients with SLE or lupus.

RN: What are Sm peptide antibodies and how does that impact rheumatologists and patients with undiagnosed lupus?

VJ: Good question. So, Sm peptide antibodies are antibodies that are specific to patients that have lupus erythematosus. Sm antibodies are specific to patients with lupus SmD3, specifically, is more specific to patients with lupus and can help differentiate between lupus and mixed connective tissue disease. So therefore, going back to the Thermo Scientific EliA SmDP-S, that utilizes the SmD3 peptides, a synthetic version, which is more specific to lupus and therefore provided a greater differentiation between 2 different types of connective tissue diseases.

RN: What is the clinical significance of this test?

VJ: The clinical significance is the differentiation between lupus and mixed connective tissue disease, specifically.

RN: How can this test improve outcomes for patients with SLE?

VJ: The Thermo Scientific EliA SmDP-S will, with the SmD3 peptide that's utilized, and a updated coding that the test has been designed with, will improve the sensitivity and specificity of this assay, and therefore will be able to give clinicians that greater diagnostic confidence, being able to say whether a patient truly has lupus, or has mixed connective tissue disease. So, add to that differential within the many different diseases that they're trying to rule out in diagnosing that patient.

RN: Does your team plan on doing any further research on this topic?

VJ: Great question. So, I think anyone that is involved in autoimmune diseases is always looking to identify ways that can improve the diagnosis for patients. So, our team researchers across the world are continuously looking to see how the field is going to evolve from a diagnostic standpoint.

RN: Is there anything else that you would like our audience to know about lupus, the work that you're doing, or anything else related to this field before we wrap up?

VJ: I would highlight again the importance of the Thermo Scientific EliA SmDP-S assay and the uniqueness of this particular assay with the updated coating and the utilization of the synthetic SmD3 peptide. You really do give clinicians the greater diagnostic confidence that sometimes is lacking within connective tissue disease, or CTD, diagnosis. So giving clinicians that greater confidence will ultimately help improve patient outcomes, diagnose patients at a quicker rate instead of having to wait through other diagnoses. The only other thing that I would add beyond that is our Thermo Scientific EliA SmDP-S enhances specificity without sacrificing sensitivity so really gives an ideal of both sensitivity and specificity which leads to that precise diagnosis. Therefore, you have fewer false positives, so it not leading the clinician down the wrong path of diagnosing a patient.