To reiterate the message from our CEO, August J. Troendle, Medpace is committed to assist in the fight against COVID-19, which aligns with our mission of accelerating the global development of safe and effective medical therapeutics.
Medpace has a highly-experienced infectious disease team, including medical, regulatory, operational, and laboratory experts who have extensive experience designing and conducting infectious disease clinical trials. Our team is actively working with the global regulatory authorities and Sponsors responding to the COVID-19 situation.
COVID-19 Testing Capabilities
To serve our Sponsors in their COVID-19 programs, Medpace has expedited COVID-19 assay validations to meet clinical trial testing standards.
- Whole genome sequencing NGS method to monitor SARS-CoV-2 variants
During late 2020, the emergence of variants that posed an increased risk to global public health prompted the characterization of specific Variants of Interest (VOIs) and Variants of Concern (VOCs), in order to prioritize global monitoring and research, and ultimately to inform the ongoing response to the COVID-19 pandemic.
To help in this effort, Medpace developed an NGS method to monitor changes to the virus’ genome. This method allows identification of all known variants and lineages and determines their geographical spread. It also allows identification of any de-novo mutations that may indicate a new variant of interest and variant of concern. Medpace uses as little as 200 microliters of virus transport media with a viral load of 1000 copies/mL or more to extract RNA, build libraries and sequence the whole genome of the virus. The results are usually available within 2 weeks from sample reception.
SARS-CoV-2 RT-PCR Testing
- SARS-CoV-2 QUANTITATIVE RT-PCR
- Fully validated Lab Developed Test (LDT)
- Absolute quantification of the virus copy number (viral load)
- Validated sample types: NP/OP swabs and saliva
- SARS-CoV-2 QUALITATIVE RT-PCR
- The Abbott RealTime SARS-CoV-2 assay is a dual target assay for the RdRp and N genes
- The test is FDA-approved under an Emergency Use Authorization (EUA)
- Specificity of 100% and a sensitivity of ≥95%
- Validated sample types: NP/OP swabs, plasma, saliva, sputum, urine, and pleural fluid
- Reported result turnaround time: 24-48 hours after sample receipt
SARS-CoV2 Antibody Testing
- Test Name: Anti-SARS-CoV-2
- Instrument: Cobas e801
- Method: ECLIA
- Antigen: nucleocapsid (N)
- Detects: Pan-Ig
- Specificity of 99.8% and a sensitivity of 100%
- Test Name: SARS-CoV-2 S1/S2 IgG
- Instrument: Liaison XL
- Method: CLIA
- Antigen: S1/S2 spike
- Detects: IgG
- Specificity of 99.3% and a sensitivity of 97.6%
- Test Name: SARS-CoV-2 Total
- Instrument: ADIVIA Centaur
- Method: CLIA
- Antigen: S1 spike
- Detects: IgG and IgM
- Specificity of 99.8% and a sensitivity of 100%
Cytokine and Inflammatory Markers
- Medpace supports COVID studies with an extensive test menu of cytokine and inflammatory marker biomarkers
In addition to COVID-19 testing, Medpace has a robust test menu list of respiratory virus PCR assays.
Medpace will continue to add capabilities to address Sponsor needs – please contact us with specific requests. Medpace can develop custom assay work, including viral functional assays and flow cytometry, to support viral infection studies.
Our wholly-owned global laboratory facilities, standardized testing platforms, comprehensive test menu, and stellar project management teams allow Medpace to set up fully customized projects for our Sponsors. Combined with Medpace Clinical Research Organization expertise, we provide a fully integrated solution for your clinical development needs.
Central Labs for Infectious Diseases
Medpace’s central laboratory in house capabilities, coupled with strategic laboratory partnerships with top labs in microbiology and virology, provide the specific testing required for each study. This approach streamlines timelines, simplifies requirements for sites, and provides a centralized model for communication.
Medpace Advantages for Infectious Diseases Studies
- Access to top research scientists who are therapeutically focused on infectious disease, deliver regulatory-quality reports and meet the tight timelines demanded in ID trials
- With Medpace central labs coordinating the shipping between sites and labs around the world, logistics are greatly simplified, resulting in higher efficiency
- Specialty labs integrate seamlessly with Medpace’s full-service approach to clinical trial management
Central Lab Services
- Bacterial Identifications
- Microbial Cultures
- Fungal Identifications
- Molecular Characterization
- Phage testing
- In vitro drug susceptibility testing
- TB Testing (Quantiferon Gold)
- Infectious Disease Serology
- Viral Loads
- Viral Infectivity
- Virus Titer Using TCID50
If you are developing treatments for COVID-19 and need assistance, Medpace is well-equipped to assist:
- Speed: Our proven flat operating model and our multi-disciplined approach are designed for efficiency. We are well-equipped to move quickly and have taken steps to accelerate contracting and site-startup
- Site and investigator relationships: We are able to leverage strong relationships to assess feasibility quickly, accelerate enrollment and move trials forward
- Regulatory engagement: Knowledgeable in the changing regulatory landscape at local, regional, and global levels. Our team can provide regulatory support and strategy
- Remote monitoring tools and technology: Our processes and technology platforms enable remote monitoring and fast data acquisition. We support both sites and patients with portals for accessing and recording data that is easily accessible. We can support alternative methods for safety assessment, including phone contacts and virtual visits
- Government and research agencies: Our experience and relationships allow us to collaborate with government agencies and other research institutions, such as BARDA, NIH, and Wellcome-Trust
- Critically ill patients: We have extensive experience in acute care settings with critically ill patients, spanning pediatric to geriatric patients
- Advanced therapies: Extensive experience working with Sponsors to overcome development challenges and accelerate cutting-edge technologies including cell and gene therapies
- Testing: Medpace’s central laboratories currently can test for COVID-19 via an FDA-approved RT-PCR assay in our US laboratory and will have the assay available in our Europe laboratory mid-April.