PROGENTEC DIAGNOSTICS INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

PROJECT SUMMARY ABSTRACTSystemic lupus erythematosusSLEis a multifaceted autoimmune disease characterized by immune dysregulationdisabling symptoms and progressive organ damageRecognition and early treatment to prevent tissue and organ damage is challengingas signs and symptoms of high disease activity and clinical disease flare are captured after their occurrenceDespite clinical instruments of disease activity and improved treatment regimens to temper chronic inflammationSLE patients may experience an average ofdisease flares annuallyCurrent treatment for ongoing heightened clinical disease activity and disease flareswhich must be done in reactiverather than proactivefashiontypically relies on rapidly actingtoxic agents such as steroidsEarlier identification and proactive treatment of heightened clinical disease activity and imminent disease flare might prevent significant organ damage and improve the quality of life for patients with SLEOur scientific premise is that alterations in SLE associated immune pathways underlie ongoing clinical disease activity and future disease flareTraditional biomarkers incorporated in clinical disease activity measures are not necessarily the earliestnor sufficientbiologic signals of worsening diseaseUsing a multianalyte approachwe initially determined that lupus patientsprior to disease flarehave additional immune dysregulation of multiple and varied immune pathwaysThis information was transformed into a Lupus Flare Prediction IndexLFPIthat reflects the pre flare immune status in lupus patients who go on to flareLupus patients with ongoing heightened clinical disease activity are also at risk for permanent organ damageWe therefore leveraged our initial studies to evaluate immune dysregulation in lupus patients with current low disease activity vsactive clinical diseaseAgainwe observed alterations in multiple and varied immune pathwaysbut in a different manner than what occurred prior to disease flareThis led us to design a Lupus Disease Activity Immune IndexLDAIIthat correlates well with clinical disease activity measuresOur proposed research in Phase I Aimwill focus on determining a distinct subset of SLE associated mediators that best inform this novel LDAIIwith validation of the LDAII during Phase II Aimin SLE patients with concurrent low vsactive clinical disease activity from ethnically diverse patient cohortsAccess to these SLE cohorts will also allow for the validation of our innovative LFPI in Phase II Aimin SLE patients with preflare vsnonflare periods based on their future clinical disease activityA successful outcome of this proposal will be optimizedvalidated LDAII and LFPI tests that are a game changer in the lupus space by allowing proactiverather than reactivedisease managementThis study will also allow Progentec to transition these tests to a clinical lab certified by the College of American PathologistsCAPand Clinical Laboratory Improvement AmendmentsCLIAprocure codes for reimbursementand launch clinical trials in Phase III PROJECT NARRATIVE Systemic lupus erythematosusSLEis a prototypic systemic autoimmune disease which causes significant morbidity and early mortalityespecially in young minority womenSLE patients are at risk for ongoing heightened clinical disease activity and disease flares that often result in end organ damageand are only identified after clinical signs and symptoms have occurredWe propose to measure a select panel of blood proteins that are known to activate or regulate the immune system and feed the results into innovative mathematical algorithms that assign a singleimmune system informed and clinically actionable disease activity or flare prediction score to provide proactive information as to which SLE patients are likely to have heightened clinical disease activity or who are at risk of imminent disease flarepositive scorefor early interventionorgan damage preventionand reduced need for treatments that carry damaging side effects