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Medical and Scientific Affairs

Unleashing medical and scientific insights for healthcare professionals to catalyze patient outcomes

As healthcare systems face changing demands, delivering healthcare efficiently is more critical than ever. Access to improved methods for diagnosing, preventing and treating diseases is crucial. In-vitro diagnostics account for about 2% of healthcare spending; however, they inform around 70% of clinical decision-making processes.¹ 

The Roche Diagnostics medical and scientific affairs team recognizes healthcare professionals' pivotal role. We are dedicated to providing HCPs with unparalleled medical and scientific insights, empowering them to spearhead innovation and improve patient outcomes.

We aim to provide engagement, evidence and education to drive change in conditions and disease areas of interest.

Contact us

This page is provided as a contact service and does not replace the advice of a physician. Roche cannot respond to questions about general medical information or questions regarding your personal medical condition. Medications and diagnostics products can not be directly ordered through this website. Please note that we do not respond to form letters or e-mail campaigns.

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Articles from our experts

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    Health topics

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      Reference

       

      1. Rohr, U. P., Binder, C., Dieterle, T., Giusti, F., Messina, C. G., Toerien, E., Moch, H., & Schäfer, H. H. (2016). The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report. PloS one, 11(3), e0149856.

       

      Submit a study proposal

      Medical and Scientific Affairs (MSA) actively supports the research needs of scientific and medical professionals through the Investigator Initiated Studies (IIS) and Roche Sponsored Studies (RSS) programs.

      Our MSA team focuses on evidence that relates to access, innovation and data needed for launch success, and evidence that will transform clinical decisions. The information listed below reflects the current areas of interest for clinical research projects. Proposals will be evaluated based on the use of Roche diagnostic solutions within disease areas listed below, with outcomes in relation to clinical and public health utility, increasing access to diagnostics and economic impact. Study proposals should represent diverse U.S. populations in regard to race, ethnicity and gender.

      Proposals can be submitted immediately and will be evaluated on a rolling basis.

      Conditions and disease areas of interest

      Conditions and disease areas of interest

      Well-designed studies that would create the evidence needed to transition the fluid biomarkers from the research framework to the clinical guidelines for Alzheimer’s disease (AD) and multiple sclerosis. The studies should enroll a diverse, representative U.S. population. Some examples of studies:

      • Concordance of fluid biomarkers with imaging/autopsy as appropriate for the disease.
      • Clinical utility of fluid biomarkers in the diagnostic pathway, therapy monitoring, and/or disease progression.
      • Cost-benefit analyses of implementing fluid biomarkers in standard of care.
      • Patient outcomes benefit of using fluid biomarkers.
      • Analytical validation and implementation of fluid biomarkers in clinical laboratories.
      • Role of digital biomarkers in predicting AD pathology and in evaluating and monitoring of AD patients.
      • Head-to-head comparison between Elecsys and other biomarker assays.
      • Real world data: Clinical use and value of implementing Elecsys CSF pTau181/Abeta42 and or tTau/Abeta42 ratios in clinical practice
      • Relevant settings: Primary care, memory clinics, neurology clinics
      • List of potential products that are relevant to study areas of interest
        • FDA cleared: Elecsys CSF pTau181/Abeta42, Elecsys CSF tTau/Abeta42
        • RUO products: pTau181, ApoE4, GFAP, NfL, incoming pTau217
       
      Study proposal considerations
      1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
      2. Is the research proposal unique and of major scientific or medical importance?
      3. Do we have resources to support it?
      Submit a proposal

      Featured FDA-cleared products

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        • Implementation and utility of blood culture identification (BCID) panels in unique patient care settings (eg, critical access hospitals, rural hospitals, etc.) or patient populations (eg, pediatrics)
        • Real world impact of BCID panels on patient, clinical, and antimicrobial stewardship outcomes
        • Cost-benefit of implementing BCID panels compared to traditional testing methods
        • Clinical, patient or health-economic impact of incorporating rapid Cdiff NAAT tests into C. difficile infection testing algorithm (+/- GDH, EIA) or as standalone assay
        • Implementation of critical pathogens or AMR targets into routine workflow processes of the cobas x800 system on the open utility channel
        • Relevant settings: Critical access hospitals, rural hospitals, academic medical centers
        • List of potential products that are relevant to study areas of interest: eplex BCID panels (Gram-negative, gram-positive, fungal), cobas liat Cdiff, cobas omni Utility Channel

        Featured FDA-cleared products

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          Study proposal considerations
          1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
          2. Is the research proposal unique and of major scientific or medical importance?
          3. Do we have resources to support it?
          Submit a proposal

          Real world data:

          • Concordance of HER2 CISH with FISH
          • Workflow, accuracy, and timing studies for HER2 IHC/ISH quantitative image analysis algorithms
          • Impact of HER2 image analysis algorithms on pathologist scoring and impact on patient care
          • Effect of preanalytics on IHC/ISH manual or quantitative image analysis scoring
          • Generation for prevalence of HER2 gene amplification in HER2 0/1+ IHC
          • Impact of HER2 image analysis algorithms on pathologist scoring and impact on patient care

          Relevant settings: Research and anatomic pathology laboratories, remote diagnosis
          List of potential products that are relevant to study areas of interest: Breast Cancer IHC ISH portfolio, HER2 (4b5), HER2 Dual ISH, uPath image analysis algorithms

          Featured FDA-cleared products

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            Study proposal considerations
            1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
            2. Is the research proposal unique and of major scientific or medical importance?
            3. Do we have resources to support it?
            Submit a proposal
            • Clinical utility and implementation of cardiac biomarkers
              • In evaluating type 2 diabetes (T2D) patients who are at greater risk of developing heart failure (HF).
              • In identifying who among T2D patients will best benefit from optimal cardio-protective medication
            • Clinical utility and implementation study population / cohort representing diversity in race, ethnicity and gender
            • Clinical utility and implementation study reflective of the following HCPs
              • ERMD, cardiologists, hospitalists, primary care physician (PCP), advanced practice provider (Pharm.D., PA, NP, etc) and laboratorians
            • Implementation studies in real world setting, such as
              • Guideline protocols/ algorithms using cardiac biomarkers for risk stratification of patients at risk of developing HF
              • Disease monitoring and management in HF patients (post-discharge after an acute HF event, GDMT uptitration (STRONG-HF), in stable chronic HF)
            • HECON models
            • Relevant setting:
              • In-hospital setting (ER, pre-discharge)
              • Out-patient / ambulatory setting
                • Non-acute, and/or decentralized settings (emergency department, urgent care clinics, physicians’ offices, mobile units, community pharmacies)
                • Healthcare provider directed, lab collection
            • Potential product that are relevant to study areas of interest: NTproBNP
             
            Study proposal considerations
            1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
            2. Is the research proposal unique and of major scientific or medical importance?
            3. Do we have resources to support it?
            Submit a proposal

            Featured FDA-cleared product

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              • Human papillomavirus (HPV) primary screening- implementation, clinical outcomes, health economic studies
              • HPV self-collection implementation in different settings, especially with a focus on utility in clinical settings with instruction of a healthcare worker
              • Potential products that are relevant to study areas of interest: CINtec PLUS Cytology

              Featured FDA-cleared product

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                Study proposal considerations
                1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
                2. Is the research proposal unique and of major scientific or medical importance?
                3. Do we have resources to support it?
                Submit a proposal
                • Real world data:
                  • Workflow, accuracy and timing studies for digital pathology and quantitative image analysis algorithms
                  • Effects of preanalytics on breast quantitative image analysis scoring
                • Impact of HER2 quantitative image analysis algorithms on pathologist scoring and impact on patient care
                • Relevant settings: ambulatory, out-patient clinic utilizing PAs, NPs, pharmacists
                • Potential products that are relevant to study areas of interest: Roche Digital Pathology Total Solution

                Featured FDA-cleared product

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                  *For Research Use Only. Not for use in diagnostic procedures.

                   
                  Study proposal considerations
                  1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
                  2. Is the research proposal unique and of major scientific or medical importance?
                  3. Do we have resources to support it?
                  Submit a proposal
                  • Clinical utility and health economic impacts of respiratory assays, especially targeted (2-5 pathogens) and expanded/syndromic (6+ pathogens) multiplex PCR solutions, across diverse patient populations and settings of care
                    • Outcomes of interest include, but are not limited to: impacts to patient management and clinical outcomes, patient triage, infection control, resource/bed management, and antibiotic/antiviral stewardship
                    • Settings of interest include but are not limited to: non-acute, and/or decentralized settings (emergency department, urgent care clinics, physicians’ offices, mobile units, community pharmacies)
                  • Clinical utility of quantitative SARS-CoV-2 measurements in patient management
                  • Methods to increase awareness of and improve diagnostic stewardship in respiratory test ordering
                  • Mechanisms to increase awareness of and access to respiratory diagnostic solutions for underserved populations
                  • Estimation of the disease burden caused by respiratory pathogens across diverse patient populations
                  • List of potential products that are relevant to study areas of interest: 
                    • cobas liat system
                      • cobas liat SARS-CoV-2 assay
                      • cobas liat Influenza A/B & RSV assay 
                      • cobas liat SARS-CoV-2 & Influenza A/B Assay 
                      • cobas liat SARS-CoV-2, Influenza A/B & RSV Assay2 
                      • cobas liat Strep A Assay 
                      • cobas liat Bordetella Panel2
                    • cobas eplex system
                      • eplex Respiratory Pathogen Panel 2 
                    • cobas 5800/6800/88003
                      • cobas SARS-CoV-2 & Influenza A/B v2 Test1
                      • cobas SARS-CoV-2 Test1
                      • cobas SARS-CoV-2 Qualitative Test
                      • cobas SARS-CoV-2 Duo Test1
                      • cobas Influenza A/B & RSV UC Test4
                      • cobas Respiratory flex Test2
                      • cobas omni Utility Channel
                    • cobas e 411 analyzer, e 601/602 modules, e 801 module
                      • Elecsys® Anti-SARS-CoV-2 Assay1
                      • Elecsys®Anti-SARS-CoV-2 S Assay1
                   
                  Study proposal considerations
                  1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
                  2. Is the research proposal unique and of major scientific or medical importance?
                  3. Do we have resources to support it?
                  Submit a proposal

                  Featured FDA-cleared products

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                    ...
                    1. This product is authorized for use under the Emergency Use Authorization declaration.
                    2. This product is in development; design goals and product name are subject to change.
                    3. Assay availability varies by platform. Please reference the product insert for platform compatibility.
                    4. This product is for research use only (RUO).
                    • Outcomes of untreated STIs
                    • Broadening access - Workflow and outcomes of moving STI testing closer to the patient (i.e. point of care testing, self-collection and/or at-home collection and testing)
                    • Syphilis testing, especially in non-traditional settings
                    • Digital health solutions for all stages of STI diagnostic testing, reporting and/or connection to care
                    • Prevalence of antimicrobial resistance (neisseria gonorrhoeae, mycoplasma genitalium)
                    • Approaches to the STI disease area encompassing implementation science and related ancillary services (social work, public health, etc.) with an understanding that is inclusive of everyone that is sexually active with more diverse categorization
                    • PCR testing for lesions, including, but not limited to, syphilis, herpes simplex virus, varicella-zoster virus and mpox
                     
                    Study proposal considerations
                    1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
                    2. Is the research proposal unique and of major scientific or medical importance?
                    3. Do we have resources to support it?
                    Submit a proposal
                    Human immunodeficiency virus
                    • Cost-effective analyses of the current CDC human immunodeficiency virus (HIV) screening algorithm vs alternative algorithm using HIV 1/2 qualitative as second step
                    • Clinical utility of quantitative vs. qualitative NAAT testing for monitoring patients under potent PrEP
                    • Advantages/disadvantages: NAAT qualitative vs. quantitative
                    • Cost-effective analyses of qualitative vs. quantitative
                    • HIV-2 prevalence
                    • Clinical utility of Ag/Ab +NAAT screening/monitoring of populations on PrEP vs. Ag/Ab only or NAAT only
                    • Dried blood spots, plasma separation cards and at-home collection kits as alternative sample types for HIV screening / PrEP monitoring
                    Hepatitis C
                    • Role of hepatitis C (HCV) dual antigen/antibody testing in HCV micro-elimination programs in the U.S.
                    • Clinical utility of HCV Duo (dual antigen/antibody testing) in diagnosing HCV in risk populations
                    • Head-to-head study comparing the rapid diagnostic tests and anti-HCV / HCV Duo in the same study cohort
                    • Dried blood spots and plasma separation cards as a sample type in HCV elimination programs
                    Hepatitis D
                    • Real world data: Prevalence of hepatitis D (HDV)
                    Hepatitis B
                    • Clinical utility of hepatitis B (HBV) - RNA quantitative assay
                    Transplant
                    • Diagnosis and epidemiology of congenital cytomegalovirus (CMV)
                    • Real-world data
                      • Demonstrating the importance of implementing CMV, Epstein-Barr Virus and BK polyomavirus IVD assays and clinical outcomes
                      • Diagnosis and epidemiology of congenital CMV
                         
                     
                    Study proposal considerations
                    1. Does the purpose of the study align with Roche Diagnostics' medical strategy?
                    2. Is the research proposal unique and of major scientific or medical importance?
                    3. Do we have resources to support it?
                    Submit a proposal

                    Funding support

                    We eagerly sponsor opportunities and programs that increase the scientific and medical understanding of healthcare professionals.

                    Areas we support
                    • Continuing medical education (CME) programs
                    • Conference/congress/symposia
                    • Workshops
                    • P.A.C.E.® accredited content
                    • Grand rounds
                    • Continuing education unit (CEU) for nurse education
                    • Independent Education Programs (IEP)
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                    PACE® courses

                    Descriptions about new PACE course offerings appear below the instructions on this page. 
                    Instructions
                    1. Sign in or register for Roche Diagnostics University (RDU).

                    2. Go to the PACE content library and search for the title of the course you’d like to take.

                    3. Take the course and applicable assessment. Once complete, you’ll have the certificate in your learning history tab.

                     

                    For more detailed instructions, download our PDF.

                    If you need any assistance, contact our commercial education team.

                    If you have questions about course content or would like to request a live session, contact our medical and scientific affairs team.

                    Core lab

                    Core lab

                    There is a need to develop diagnostics and therapeutics that can make an impact in Alzheimer’s. Healthcare providers will utilize fluid biomarkers as part of the Alzheimer’s diagnostic workup, and laboratory professionals will play an essential role along the clinical care pathway. Take the course

                    Early detection of Alzheimer’s pathology can occur in vivo using fluid biomarkers and/or positron emission tomography (PET) imaging. The cerebrospinal fluid (CSF) ratios A𝛃42/A𝛃40 and pTau181/A𝛃42 are reflective of Alzheimer's pathology and correlate with PET. This program will also discuss CSF biomarkers laboratory implementation. Take the course

                    In 2022, the American Diabetes Association released a Consensus Report on Heart Failure: An Underappreciated Complication of Diabetes and recommended at least yearly biomarker screening to identify patients with early stages of heart failure. This program will discuss the importance of biomarkers to identify more patients with undiagnosed heart failure. Take the course

                    About 6.2 million adults in the United States have heart failure (HF), and more than 900,000 new cases are diagnosed every year. The mortality rate for chronic HF is ~50% at 5 years post-diagnosis. HF costs the nation an estimated $30.7 billion in 2012, and a major contributor to these costs are hospitalizations. Acute HF patients are often under-treated and not on all available Guideline-Directed Medical Therapies (GDMT: ACEi/ARB/ARNi, MRA, BB, SGLT2i) or at low dose. Two major concerns for not prescribing full doses are patient safety and frailty. STRONG-HF was designed to assess the safety and efficacy of rapid up-titration of evidence-based GDMT and close follow-up (physical examination, NT-proBNP concentrations) compared to usual care and was terminated prematurely due to superior results in the intensive intervention arm in October 2022. Take the course

                    The prevalence of cancer in the U.S. population is 18.1 million and is projected to increase to 26 million by the year 2040. Currently 47% of the U.S. population has lived for at least 10 years since their cancer diagnosis, reflecting improvement in cancer survival and increase in life expectancy. However, cancer and cardiovascular (CV) disease are still the leading causes of death worldwide. When these two diseases occur together, the burden of CV disease and mortality in patients with cancer becomes substantial. There is a need to identify and monitor patients’ risk to mitigate events and facilitate cancer and CV management and treatment. This session will provide the viewer the current definition of cardiotoxicity and the potentially cardiotoxic cancer therapies, and the role of cardiac biomarkers throughout the patient journey. Take the course

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                    Molecular

                    Molecular

                    Digital PCR has proven its utility in the precise detection of low-abundance mutations, indicating its value not only in early diagnosis but also as a powerful tool to guide informative treatment decisions. Here, we will review the principle of digital PCR and its applications across the cancer care continuum. Take the course

                    Elimination of HCV transmission will require a collective effort, starting with awareness, appropriate and effective screening and diagnostic testing practices. Despite great strides in the treatment of HCV with direct-acting antivirals, the burden of HCV remains high in the U.S. and globally. This presentation will include a brief overview of the patient journey of HCV infections in the U.S., highlight some of the challenges with HCV patient management and discuss the importance of early and effective diagnosis and linkage to care. Take the course

                    This educational presentation includes audience response questions and patient case scenarios designed to provide insight and improve audience knowledge regarding the clinical, economic and/or stewardship impact of using rapid diagnostics for blood culture identification with a specific focus on how these instruments improve outcomes. Take the course

                    One of the goals of the U.S. Ending the HIV Epidemic (EHE) initiative is to have 50% of people who could benefit from PrEP (pre-exposure prophylaxis) using it by 2030. Routinely used diagnostic tests fail to detect early infection, leading to adverse health outcomes. Based on this new evidence, the CDC updated the PrEP guidelines to include testing with antigen/antibody (Ag/Ab) and Nucleic Acid Amplification Test at every PrEP monitoring visit. Take the course

                    Precision oncology, using comprehensive genomic profiling (CGP), has the potential to significantly improve cancer care. Identifying specific genetic changes in a cancer can match patients with treatments. This session is meant to educate the viewer on the need for CGP and how it provides deeper insights into therapy choices. Take the course

                    Pathology

                    Pathology

                    Biomarker testing has become part of the diagnostic landscape in breast cancer and is required to identify appropriate treatment and prognosis for patients. Due to the essential nature of these tests, specimen handling is of the utmost importance to ensure reliable and valid results. Take the course

                    In 2022, lung cancer was the second most common cancer diagnosed and responsible for the most deaths. Identification of actionable biomarkers in NSCLC has redefined the therapeutic landscape. The session aims to educate on the characteristics, diagnosis, biomarker testing and treatment implications of lung cancer. Take the course

                    Human papillomavirus (HPV) is known to cause over 93% of cervical cancer. Early diagnosis and treatment, as well as vaccines, could eliminate this cancer. This presentation will discuss cervical cancer screening and management guidelines and provide an overview of different methods for screening and triage of patients. Take the course

                    Breast cancer affects 1 in 8 women in the U.S., with only a 30% rate of 5-year survival for metastatic patients. Breast cancers that have human epidermal growth factor receptor 2 (HER2) immunohistochemistry (IHC) scores of 1+ or 2+ with negative in-situ hybridization (ISH) represent around 50% of breast cancers. The aim of this session is to enable laboratories to meet the needs of their clinicians by properly segmenting patients with low-level expression of HER2 and its implications for clinical lab professionals and patients. Take the course

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                    Point of care

                    Point of care

                    Viral infections are common among patients admitted to hospitals with acute respiratory failure. As viral respiratory infections may be clinically and radiographically indiscernible from bacterial infections, the use of rapid viral respiratory diagnostics may have the potential to decrease inappropriate antibiotic use by increasing diagnostic certainty. In this session, we review the current respiratory season and data supporting the impact of rapid respiratory diagnostics on antimicrobial stewardship efforts. Take the course

                    The pandemic has brought about an opportunity to perform diagnostic testing in new ways. Solutions, such as devices for remote patient monitoring, over-the-counter tests and collection of samples in patients’ homes have changed the workflow of traditional laboratory testing. Along with opportunity, however, there are also challenges that must be addressed. This session will discuss the different ways that testing has evolved, the impact to the clinical laboratory and the future of diagnostics in the continuum of care. Take the course

                    These PACE courses are strictly for educational and scientific purposes and have no commercial interactions or expectations associated with them. If you have questions about these courses, please reach out to your Roche medical and scientific affairs liaison. Statements made in the course descriptions below have citations included in the courses themselves unless otherwise noted.