Thursday, August 21, 2025 8/21/2025

Saliva Anti-SSA/Ro and Anti-SSB/La for Early Detection of Sjögren’s and SICCA Syndromes

Award Number: R21DE033901
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Saliva Anti-SSA/Ro and Anti-SSB/La for Early Detection of Sjögren’s and SICCA Syndromes - Project Summary/Abstract: Early detection of Sjögren’s Disease (SjD) and its precursor autoimmune-Sicca Syndrome (AI- Sicca), are unmet clinical needs. Serum anti-Ro/SSA autoantibodies and biopsy focus score are two key classification criteria of SjD by the 2016 ACR-EULAR 1. SjD is a complex disease. Clinicians provide symptomatic treatment to patients as the symptoms of SjD are similar to other physiological and pathological changes in the body including menopause, drug side effects and fibromyalgia amongst others. This leads to a 3-year delay in initial diagnosis from the time the patients first seek medical care. In addition, there is currently no test for the diagnosis of AI-Sicca. In order to address this unmet clinical need, we have developed a saliva-based electrochemical assay, electric field-induced release and measurement (EFIRM), that can screen, earlier detect and risk assess onset of SjD, alternative to the current ELISA blood-based serology assay. Preliminary data demonstrated: 1) EFIRM can directly detect and quantify salivary anti-SSA/Ro52 autoantibodies in SjD patients; 2) Salivary and serum anti-SSA/Ro52 are correlated in SjD and AI- Sicca patients; 3) Salivary anti-Ro52/SSA IgA1 correlate to salivary gland focus scores. This R21 application will test the hypothesis in a large cohort of SjD and AI-Sicca patients that EFIRM, can: 1) detect anti-SSA/Ro52 and anti-SSB/La in saliva of SjD and AI-Sicca patients, and 2) salivary IgA1 to SSA/Ro52 is associated with salivary gland tissue destruction as measured by focus scores. Furthermore, monomeric versus polymeric forms for IgA1 to salivary SSA/Ro52 can discriminate SjD from AI-Sicca patients. Should this hypothesis be validated, the EFIRM salivary anti-SSA/Ro52 and anti-SSB/La assays can be explored for early detection of SjD and AI-Sicca in prospective multi-site clinical study as well as basic science mechanistic pursuits. In addition, saliva monitoring of IgA1 to SSA/Ro52 can be hypothesis tested for monitoring AI-Sicca progression to SjD in a non- invasive sample type (saliva). Three specific aims are proposed for this project. Specific Aim1: Acquire and Characterize Clinical cohorts of SjD, AI-Sicca and matched control subjects. Specific Aim 2: EFIRM quantitative assessment of anti-SSA/Ro52 and anti-SSB/La in saliva of SjD, AI-Sicca and Controls. EFIRM SSA/Ro52 and SSB/La autoantibody immunoassays will be performed on 210 SjD, 210 AI-Sicca and 315 controls subjects (blinded and randomized). Hypothesis testing of saliva SSA/Ro52 and SSB/La autoantibodies to discriminate 1) SjD vs AI-Sicca; 2) SjD vs Controls; 3) AI-Sicca vs Controls and 4) (SjD + AI-Sicca) vs Controls. Specific Aim 3: Quantification of monomeric and polymeric anti-SSA/Ro52 IgA1 in saliva of SjD and AI-Sicca patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $205,001 )
2025	2025	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Oral Diseases and Disorders Research	001	2	7/21/2025	NON-COMPETING CONTINUATION	$205,001
2025	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	1	7/17/2025	NEW	$0
														Subtotal = $205,001

Issue Date FY: 2024 ( Subtotal = $260,375 )
2024	2024	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Oral Diseases and Disorders Research	000	1	9/16/2024	NEW	$260,375
														Subtotal = $260,375

Grand Total All Awards = $465,376

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Saliva Anti-SSA/Ro and Anti-SSB/La for Early Detection of Sjögren’s and SICCA Syndromes

Award Number: R21DE033901

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/16/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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