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PEARL DIAGNOSTICS, INC.
BALTIMORE, MD, 21205
UnclaimedClaim this profile (free)
Small Business
Subcontracting experience
1 record from government sources. Past participation is not evidence of current teaming interest.
| Role | Agency | Description | Vehicle | Obligated | Action date | Period |
|---|---|---|---|---|---|---|
| Subcontractor | Department of Health and Human Services | PEARL DIAGNOSTICS INC. (PEARLDX) DEVELOPS NOVEL IN VITRO DIAGNOSTIC (IVD) TESTS THAT AID NON-INVASIVE DIAGNOSIS OF LIFE-THREATENING LUNG INFECTIONS. PEARLDX€„¢S TECHNOLOGY LEVERAGES THE DISCOVERY THAT MICROBIAL EXTRACELLULAR VESICLES (EVS) RELEASED FROM ORGANISMS GROWING IN THE LUNGS ARE EXCRETED IN URINE. IDENTIFICATION OF SPECIFIC LUNG PATHOGENS SUCH AS PSEUDOMONAS AERUGINOSA (PSA) AS A CAUSE OF PNEUMONIA IS CRITICAL IN MITIGATING THE IMPACT OF ANTIMICROBIAL DRUG RESISTANCE. WHILE A LESS COMMON CAUSE OF COMMUNITY-ACQUIRED PNEUMONIA (CAP), THIS GRAM-NEGATIVE ROD (GNR) IS INTRINSICALLY RESISTANT TO SEVERAL ANTIBIOTIC CLASSES, INCLUDING B-LACTAMS, AND EXHIBITS FREQUENT MULTIDRUG RESISTANCE (MDR). THE PREVALENCE OF PSA IN CAP IS REPORTED AS VARIABLE, RANGING FROM 0 TO 23%, WITH A POOLED PREVALENCE OF 8.6% IN PEOPLE WITH IDENTIFIED RISKS FOR MDR INFECTIONS. IDENTIFICATION OF PSA IN CULTURES ENABLES SUSCEPTIBILITY TESTING AND TAILORING OF EMPIRIC THERAPY FOR BOTH CAP AND HOSPITAL- AND VENTILATOR-ACQUIRED PNEUMONIA (HAP, VAP) IN HIGH-RISK PATIENTS. HOWEVER, THIS FREQUENTLY REQUIRES BAL SAMPLING AND CULTURE YIELD IS VARIABLE. IDENTIFICATION OF THE ORGANISM IS NOT AN ASSURANCE OF ACUTE DISEASE ETIOLOGY, AS COLONIZATION IS COMMON IN PEOPLE WITH POOR AIRWAY CLEARANCE, SUCH AS IN THOSE WITH BRONCHIECTASIS AND CYSTIC FIBROSIS (CF). VARIABLE PERFORMANCE, NON-SPECIFICITY OF CLINICAL FINDINGS, RELIANCE ON INVASIVE SAMPLING, AND TIME TO CULTURE DRIVE A HIGH AMOUNT OF ANTIBIOTIC EMPIRICISM, ULTIMATELY GENERATING AND PROPAGATING ANTIMICROBIAL RESISTANCE (AMR). PEARLDX€„¢S PRODUCTS PROVIDE ADVANTAGES WITH REGARD TO ACCESS (REFERENCE LABS VS. LOW-RESOURCE SETTINGS), COSTS (> $2000/TEST VS. < $20), AND TIME TO RESULT (3-5 DAYS VS. < 2 HR.). OTHER TECHNOLOGIES TYPICALLY RELY ON LARGE INSTRUMENTS AND/OR REFERENCE TESTING. THEREFORE, THERE REMAIN CRITICAL UNMET NEEDS AND OPPORTUNITIES TO IMPROVE PATIENT OUTCOMES WITH EASIER-TO-DEPLOY, LESS EXPENSIVE IVDS USING URINE AS AN ADJUNCT DIAGNOSTIC AID FOR PNEUMONIA. THE AVAILABILITY OF ADJUNCTIVE NON-CULTURE-BASED TESTS (NCBT) TO AID IN THE DIAGNOSIS OF PNEUMONIA IS A LONG-APPRECIATED PRIORITY. PEARLDX, WITH SUPPORT FROM CARB-X, INTENDS TO DEVELOP A LOW-COST, LOW TURNAROUND TIME (TAT) URINE ASSAY FOR THE DETECTION OF PSEUDOMONAS PNEUMONIA (PMA). THE INITIAL AIM OF THIS PROJECT IS TO DEVELOP A PROTOTYPE ASSAY. ALL ASSAYS DEVELOPED BY PEARLDX, INCLUDING THE PROPOSED CARB-X-SUPPORTED PSA ASSAY, ARE ADVANCED USING CLINICAL SAMPLES FROM PATIENTS, WITH ITERATIVE IMPROVEMENTS OF THE ASSAY INFORMED BY THE CHARACTERIZATION OF URINARY ANTIGENS AND BY REDUCING MATRIX INTERFERENCE. 4500005280 Parent award context Parent award agency: Department of Health and Human Services · Office of Assistant Secretary for Preparedness and Response Parent award NAICS: 541714 Parent award performance state: MA Parent award description: CARB-X GLOBAL ANTIBACTERIAL ACCELERATOR OTA View parent award on USAspending | — | $750,000 | Dec 20, 2024 | — – — |
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