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.
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
Alzheimer’s disease
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
Does the purpose of the study align with Roche Diagnostics' medical strategy?
Is the research proposal unique and of major scientific or medical importance?
Do we have resources to support it?
Antimicrobial stewardship and sepsis
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 C. difficile 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: cobas eplex BCID panels (Gram-negative, gram-positive, fungal), cobas liat Cdiff, cobas omni Utility Channel
Study proposal considerations
Does the purpose of the study align with Roche Diagnostics' medical strategy?
Is the research proposal unique and of major scientific or medical importance?
Do we have resources to support it?
Breast cancer
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
Study proposal considerations
Does the purpose of the study align with Roche Diagnostics' medical strategy?
Is the research proposal unique and of major scientific or medical importance?
Do we have resources to support it?
Cardiometabolism
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
Does the purpose of the study align with Roche Diagnostics' medical strategy?
Is the research proposal unique and of major scientific or medical importance?
Do we have resources to support it?
Respiratory
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 assaycobas 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
cobas 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 Testcobas 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
Does the purpose of the study align with Roche Diagnostics' medical strategy?
Is the research proposal unique and of major scientific or medical importance?
Do we have resources to support it?
This product is authorized for use under the Emergency Use Authorization declaration. This product is in development; design goals and product name are subject to change. Assay availability varies by platform. Please reference the product insert for platform compatibility. This product is for research use only (RUO).
Sexual health
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
Does the purpose of the study align with Roche Diagnostics' medical strategy?
Is the research proposal unique and of major scientific or medical importance?
Do we have resources to support it?
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)
PACE® courses
Descriptions about new PACE course offerings appear below the instructions on this page.
Instructions
Sign in or register for Roche Diagnostics University (RDU).Go to the PACE content library and search for the title of the course you’d like to take.
Take the course and applicable assessment. Once complete, you’ll have the certificate in your learning history tab.
Core lab
Core lab
Incorporating sFlt-1/PlGF for improved preeclampsia-patient evaluation
Learn more about how the soluble fms-like tyrosine kinase (sFlt‐1)/placental growth factor (PlGF) ratio is used as a critical biomarker in predicting preeclampsia with severe features in pregnant women.* Take the course
*These CME / CE courses are strictly for educational and scientific purposes and have no commercial interactions or expectations associated with them. These CE courses are generally available and are not contingent on whether you are a customer. If you have questions about these courses, please reach out to your Roche Medical and Scientific Affairs Liaison.
Optimal Approaches to Identification of Heart Failure in People With Diabetes in the Primary Care Clinic
Do you know the latest heart failure risk assessment recommendations for people with diabetes? Tune in to the Medscape program, "Optimal Approaches to Identification of Heart Failure in People with Diabetes," and gain insights from top cardiology and endocrinology experts. Discover valuable heart failure assessment strategies for enhancing your clinical practice and with the goal to improve clinical outcomes for people with diabetes. Take the Course
A deep dive into Alzheimer’s disease and its neuropathology
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
Alzheimer's disease CSF biomarkers are here. Now what?
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
Early identification of heart failure in patients with diabetes
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
Reducing readmission rates for heart failure
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
Role of cardiac biomarkers in cancer patients receiving cardiotoxic therapy
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
Molecular
Molecular
Digital PCR in oncology diagnostics and monitoring
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
HCV elimination by 2030: Impact of simplified diagnostics in the care cascade
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
Importance and impact of rapid blood culture identification
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
Molecular testing considerations for people on PrEP
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
The power of precision oncology and genomic profiling
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 and specimen handling recommendations in breast cancer
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
Biomarkers in lung cancer
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
Cervical cancer screening and triage
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
Evolving landscape of HER2 expression and testing in breast cancer
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
Point of care
Point of care
Role of respiratory diagnostics within antimicrobial stewardship programs
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 decentralization of laboratory diagnostics
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.
