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.

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  • 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
covid map

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

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Precision’s IVD and Diagnostic Expertise

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IVD PRESUBMISSIONS, PRECLINICAL/CLINICAL TRIAL DESIGNS, AND EXECUTIONS

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MARKETING CLEARANCES AND APPROVALS FOR IVD SUBMISSIONS

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DX REGULATORY FILINGS IN COUNTRIES AROUND THE GLOBE