Welcome to Beckman Coulter's
Investigator-Initiated Study (IIS) Program

Clinical Utility of Bacterial vs Viral (BvsV) Testing in High‑Uncertainty Populations

• Clinical Utility of Bacterial vs Viral (BvsV) Testing in High‑Uncertainty Populations
• Impact of including BvsV testing in standing order sets, such as suspected sepsis, on clinical decision-making
• Impact of BvsV testing on antibiotic initiation, withholding, escalation, and de‑escalation in ED patients with community‑acquired pneumonia (CAP) and other respiratory syndromes
• Association with downstream outcomes such as length of stay, admission rates, 72‑hour revisits, and clinical deterioration

Operational and Laboratory Impact of Bacterial vs Viral (BvsV) Diagnostics

• Effect of BvsV testing on laboratory operations, including throughput, stat testing workflows, staffing, and result delivery
• Operational comparison of different deployment models (e.g., immunoassay vs molecular platforms) and implications for acute care scalability
• Performance comparisons between BvsV signatures (e.g., MeMed BV, Triverity, FebriDx) including diagnostic accuracy, workflow, ease of use, etc.

Procalcitonin‑Guided Antibiotic De‑escalation in Sepsis Management

• Real‑world evaluation of serial procalcitonin measurements to support antibiotic discontinuation or narrowing in patients with suspected or confirmed sepsis

Provider Understanding, Interpretation, and Trust in Host Response Diagnostic Results

• Assessment of clinician knowledge gaps, confidence, and decision‑making behavior related to BvsV test results
• Impact of education, interpretive guidance, and decision support on appropriate test use and clinical actionability
• Integration of host-response based lab tests to evaluate patient risk of progression to advanced interventions, such as renal replacement therapy or ventilator support, into clinical workflows

NT-proBNP/BNP

• Early identification & prevention in high-risk populations
• Screening and early risk detection in elderly patients and those with comorbidities (e.g., diabetes, renal disease)

NT-proBNP–Guided Therapy & Disease Monitoring in Chronic HF

• Evaluate goal-directed therapy guided by NT-proBNP
• Recognition that prior trials may not have been definitive; modern care models, new therapies, and primary-care involvement justify re-examination
• Evaluate for longitudinal management in primary care settings, not just specialist cardiology settings

Prognostic Stratification Beyond Acute MI

• Utilization of hsTnI as a prognostic marker, particularly for long-term risk prediction and anticipating HF severity following myocardial injury
• Evaluate use as "global injury marker" in multisystem illness, especially when embedded within multi-marker strategies

Risk Stratification in Acute or Intermediate Presentations (Selective / Adjunct Use)

• Evaluate NT-proBNP when positioned as complementary, particularly:
• HF risk prediction in NSTEMI (rather than ischemic diagnosis)
• ED patients in "intermediate risk" zones alongside hsTnI

Emerging & Non-Traditional Indications (Focused Expansion Recommended)

• Potential focus on "non-cardiac primary" disease states

Special & Understudied Populations — Pediatrics in Particular

• Reference range studies
• Performance in different disease states
• Risk stratification and prognostic indications

HEME

• Performance for detection of cellular abnormalities such as blasts, reactive/abnormal lymphocytes or immature granulocytes / (early granulocyte cells or EGC)
• Performance of platelet count in samples with interference
• Clinical value of platelet-related parameters in thrombocytopenia /post BMT/chemo patients
• Performance in various disease states:
  • Anemia screening, diagnosis, and treatment follow-up (and potential economic impact of early diagnosis), as well as iron deficiency and latent iron deficiency
  • B12 and folate deficiency
  • Anemia due to RBC abnormalities – hemoglobinopathies, red cell membrane disorders
  • AIHA (autoimmune hemolytic anemia)
• Differential diagnosis for microcytic anemia
• EPO therapy monitoring
• Detection of RBC abnormalities such as sickle cells, Howell-Jolly bodies, thalassemias, among others

Onco-hematology:

• Performance in lymphocytosis differential diagnosis- reactive vs malignant
• Performance in lymphoproliferative disorders (CLL, other non-Hodgkin lymphoma and monoclonal B-Lymphocytosis)
• MDS screening
• Determining acute leukemia lineage (lymphoid vs myeloid vs Acute Promyelocytic leukemia (APML)
• Early recognition of successful bone marrow mobilization and CD34+ count estimation/prediction time to apheresis
• Screening for infections with CBC-Diff:
  • Malaria
  • Dengue
  • Borreliosis
  • Tuberculosis
• Body Fluids performance
• UA: Bladder cancer detection (flag bladder CA)

Microbiology and Antimicrobial Susceptibility Testing (AST)

• Antimicrobial Stewardship/Antimicrobial Resistance/Infection Control
• Evaluation of MicroScan AST panels for detection of rare, novel or complex mechanisms of resistance in MDROs
• Implementation science, clinical and antibiotic utility, patient and quality outcomes, and health economics of AST diagnostic and/or antibiotic stewardship programs/initiatives
• Value and utility of accurate AST for Infection Control prevention, identification, investigation and hospital epidemiology
• Value and clinical necessity of reporting updated breakpoints, including performance of commercial devices recently cleared with updated breakpoints

Viral Hepatitis – Hepatitis B

• Operational, workflow and quality metrics for high-volume testing and reduction of repeat/confirmation testing
• Patient monitoring and screening, including maternal and those at high risk
• Improved maternal diagnosis and impact on prenatal treatment/monitoring and the prevention of congenital infections in newborns
• Evidence, implementation science and clinical value of opt-in testing programs
• Evaluation of alternative sample types to address unmet clinical needs, such as at-home collection
• Performance and clinical utility of HBV serology in pediatric population (2 years old or older) born at elevated risk of developing HBV infection
• Performance in low prevalence settings
• Descriptive studies of real-world experience post clinical implementation, including laboratory and clinical perception

Syphilis/ Rubella

• Laboratory operation and economics of reverse algorithm compared to traditional algorithm in various patient populations, including pregnant women and primary syphilis
• Improved maternal diagnosis and impact on prenatal treatment and the prevention of congenital infections in newborns
• Operational, workflow and clinical impact of reduction of repeat testing for strongly positive samples
• Evidence, implementation science and clinical value of opt-in testing programs.
• Improved maternal diagnosis and impact on prenatal treatment and the prevention of congenital infections in newborns

Performance of AST Devices for Novel Agents and Blood Donor Screening

• Analytical performance and workflow evaluation of DxI 9000 viral serologic assays in low prevalence, donor screening populations
• Health/medical economic outcomes
• Clinical utility, including addressing clinical metrics such as length of stay, morbidity/mortality
• Antibiotic stewardship intervention utility, impact on appropriate antibiotic prescribing (escalation/de-escalation), cost savings
• Laboratory workflow improvements, including time-to-results/turn-around-time

Human Immunodeficiency Virus (HIV1/2)

• Comparison of rapid diagnostic tests (RDTs) and core lab HIV assays in various patient populations
• Performance and evaluation of dried blood spot as a sample type in HIV diagnosis and monitoring
• Real-world performance for early detection of seroconversion
• Assay performance in low prevalence settings
• Performance of 4th generation HIV serology in patients receiving PEP/PrEP
• Descriptive studies of real-world experience post clinical implementation, including laboratory and clinical perception
• Validity, performance and clinical/lab impact of using a signal/cutoff threshold for reducing repeat testing for reactive results
• Transplant and Maternal Screening and Diagnostic Serology (e.g. CMV, Toxoplasma)
• Augment maternal diagnosis and impact on prenatal treatment and the prevention of congenital infections in newborns.
• Performance of CMV and toxoplasma assays in transplant donor/recipient population
• Utility of Toxoplasma serology screening/monitoring in asymptomatic or at-risk pediatric HSC and solid organ transplant patients, pre and post-transplant

ID- Other Areas of Interest

• Public Health: Surveillance and Epidemiology for Infectious Diseases
• Utility of accurate AST testing for detection, tracking and investigation of MDRO outbreaks, including epidemiology trending over time
• Detection of antimicrobial resistance in relation to a OneHealth perspective
• Evidence, implementation science and public health value of opt-in testing programs for syphilis and HBV
• Implementation science and public health value of micro-elimination testing approaches for HCV, including universal vs targeted screening

BBM and AD

• Characterize current real‑world diagnostic pathways for MCI due to AD and mild AD and identify gaps where BBMs and multi‑marker panels add value
• Assess the performance of BBMs for AD diagnosis within standard of care pathways using history, cognitive testing, and imaging where available
• Evaluate the performance of single markers versus multi‑marker panels for:
  • Differential diagnosis (AD vs non‑AD MCI and dementias)
  • Biological staging
  • Prediction of progression and cognitive decline
  • Identification of at‑risk individuals
• Compare BBM and multi‑marker panel performance with established modalities such as PET, CSF, and contemporary clinical or biological staging frameworks

Identify BBM Prognostic and Longitudinal Applications

• Generate exploratory evidence supporting BBM use to predict onset of dementia in asymptomatic at‑risk individuals such as ApoE4 carriers, individuals with a strong family history, or those with subjective cognitive decline
• Evaluate the added value of BBMs and multi‑marker panels in longitudinal cohorts for predicting:
  • Progression from subjective cognitive decline to MCI
  • Conversion from MCI to AD dementia
  • Rate of cognitive and functional decline
• Apply BBM‑based and multi‑marker models to biological staging frameworks and compare staging derived from BBMs versus CSF and PET

Real‑World Clinical Utility, Health Economics, and Societal Impact

• Evaluate real‑world outcomes when BBMs and multi‑marker panels are integrated into diagnostic pathways compared with standard of care alone
• Assess the impact of BBMs on:
  • Diagnostic confidence
  • Diagnostic labeling
  • Referral patterns for PET, CSF, or specialist evaluation
• Evaluate outcomes related to:
  • Time to diagnosis
  • Time to disease‑modifying therapy initiation
  • Hospitalization and institutionalization rates
• Assess patient‑ and caregiver‑reported outcomes including quality of life and caregiver burden
• Evaluate the impact of BBM implementation on:
  • Resource utilization
  • Cost effectiveness
  • Health system and societal impact

Neurodegenerative Disorders Priority Research Areas Cont.

• Evaluate BBM performance across care settings including:
  • Primary care
  • Memory clinics
  • Specialist neurology centers
• Explore BBM performance in community‑based, diverse, and underrepresented populations
• Assess BBM diagnostic performance in comorbid populations, such as:
  • Vascular comorbidities
  • Depression or anxiety
  • Renal or hepatic dysfunction
• Describe geographic and demographic variation in diagnostic workup, access to advanced testing, and time to diagnosis

Comparative and Head‑to‑Head Evaluations

• Comparisons of Beckman Coulter Access BBM assays and multi‑marker panels versus competitor assays
• Compare performance of:
  • Single markers versus multi‑marker panels
  • Beckman Coulter‑based panels versus competitor multi‑marker panels
  • Assays across different sample types such as serum or EDTA plasma

Reproductive Health

• Analytical validation and clinical implementation of newly launched Access reproductive assays across obstetrics/gynecology and fertility care settings
• Clinical validity studies establishing Access Anti‑Müllerian Hormone (AMH)–specific cutoffs in patients with polycystic ovary morphology (PCOM) in the context of PCOS/PMOS, across age groups, ethnicities, and phenotypic profiles
• Clinical and health‑economic evidence supporting the use of Access AMH in the assessment of premature ovarian insufficiency and determination of menopausal status
• Clinical utility studies demonstrating the impact of high sensitivity reproductive assays on the DxI 9000 analyzer on clinical decision‑making, including diagnosis, prognosis, and treatment planning
• Clinical utility studies evaluating the role of Access reproductive assays in supporting clinical decision‑making and management strategies for pediatric and male patients

Prostate Health

• Analytical and clinical validation studies evaluating the value of total PSA (tPSA) measurement on the DxI 9000 analyzer in prostate cancer management, including recurrence monitoring
• Implementation studies assessing the integration of prostate health index (phi)–based prostate cancer screening across diverse clinical practice settings
• Operational and health‑economic evaluations demonstrating the benefits of phi‑based screening strategies for prostate cancer risk assessment across populations, geographies, and clinical risk profiles
• Clinical validity studies examining the performance of phi‑based strategies in active surveillance pathways for prostate cancer
• Comparative evidence studies benchmarking phi‑based approaches against emerging prostate cancer risk‑stratification tools and addressing key unmet clinical needs