PEARL DIAGNOSTICS, INC.

• TRUSTEES OF BOSTON UNIVERSITY

  UEI THL6A6JLE1S7

  $750K

  Subcontractor to this prime · 1 sub-award · latest Dec 20, 2024

  • Office of Assistant Secretary for Preparedness and Response
  • “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 ADJUNC”

No reported sub-awards as a prime contractor.

Agencies generally may not award to excluded parties, and primes may not subcontract with them above the threshold in FAR 52.209-6 (except COTS items) without a compelling reason reported to the contracting officer (FAR 9.405, 9.405-2). Some exclusion types apply only to specific programs: read the record on SAM.gov.

No confirmed match on the Consolidated Screening List (screened Nov 13, 2026).

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