Precision for Medicine COVID-19 Resource Center
Precision supports your research with comprehensive resources that can be rapidly deployed to help ensure the conduct of your vaccine, therapeutic, or diagnostic development program.
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Strategically Accelerate COVID-19 Diagnostics from Development to Market
Thursday June 11th | 10am PT/ 1pm ET/ 7pm CET
Biospecimens to Support COVID‑19 Research
COVID‑19 Clinical Development Solutions
Diagnostics and IVD Development Support
Biospecimens Solutions for COVID-19
Application, assay, vaccine, and therapeutic development
EUA -
Sample Sets
Available Immediately – Prepared in accordance with FDA guidance
Swabs and blood specimens:
- Molecular
- SARS-CoV-2 Positive (n=30)
- SARS-CoV-2 Negative (n=80) Serological
- IgG/IgM: SARS-CoV-2 Positive (n=30)
- IgG/IgM: SARS-CoV-2 Negative (n=80, of which 10 must be HIV+)
Characterized by EUA-Approved Assays
Patient Specimens (non-contrived)
Assay Development 510(k) Preparation
Molecular Assays
- Naso and oral swabs: SARS-CoV-2 RNA
- Verified EUA method and results
Antibody Assays
- Serum and plasma: SARS-CoV-2 IgG/IgM
- Clinical Specimens from our clinics and research units
- COVID-19 diagnosed (confirmed)
- Matched sets
- Days 0, 4-11, 12-21, 21+
- Remnant Specimens from our CAP-/CLIA-certified global labs
Contract –
Research Collections
Research Collections – Samples to support the screening, diagnosis, and monitoring of COVID-19
- Convalescent plasma
- Leukopaks
- PBMCs
- Serum/Plasma
- Saliva/Sputum
- Swabs
Custom Collections
- Point-of-care devices
- Capillary/dry blood spots
- Matched sets
COVID-19 Research Registry
- ACUTE patients
- RECOVERED patients
- IRB approved/ Informed consent
COVID‑19 Clinical Development Solutions
Clinical Trial Design and Conduct
Full-service clinical trial execution with deep experience in respiratory and infectious diseases.
Precision is currently managing multiple COVID‑19 clinical trials.
- COVID‑19
- Pulmonary Arterial Hypertension
- Asthma
- Alpha-1 Antitrypsin Deficiency
- Adolescent Asthma
- COPD
- Cystic Fibrosis
- Respiratory Distress Syndrome; ABCA3 Deficiency
- Idiopathic Pulmonary Fibrosis
- Non-TB Bacterial Lung Infections
- Seasonal Allergic Rhinitis
- Influenza
- Hepatitis B
- Hepatitis C
- Hepatitis D
- HIV
- Malaria
Precision understands and can address the specific needs of COVID‑19 studies:
- Identification of site level processes and national/local guidelines to allow for rapid study start-up
- Knowledge of patient management and care guidelines to enable outreach to sites and physicians
- Verification of evolving EMA and FDA guidelines and a solution-oriented approach to obtaining patient consent, data capture, and data monitoring
IVDs and Diagnostics for COVID‑19
Clinical Trial Design and Conduct
For diagnostics companies developing:
- Point-of-care tests from multiple sample sources (Precision can supply biospecimens including nasopharyngeal swabs, blood, saliva)
- IgG, IgM, and IgA tests
- Home collection and/or home use tests
- Alternative COVID-19 responses including non-COVID-19 diagnostics applicable to COVID-19 patients
As well as laboratories bringing in their own or an approved EUA test
Precision’s IVD and Diagnostic Expertise
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IVD PRESUBMISSIONS, PRECLINICAL/CLINICAL TRIAL DESIGNS, AND EXECUTIONS0+
MARKETING CLEARANCES AND APPROVALS FOR IVD SUBMISSIONS0
DX REGULATORY FILINGS IN COUNTRIES AROUND THE GLOBE