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Dr. Linda Robbie
Posted by Dr. Linda Robbie Industry Update, Viruses

Clinical Trials and Returning to Work: COVID-19 Testing, The Path Forward

Clinical Trials and Returning to Work: COVID-19 Testing, The Path Forward

As lockdowns stemming from the COVID-19 pandemic begin to lift, the question is: where do we go from here? How do we open our companies and economies, and move much needed research in this and other disease indications forward, while keeping our workplaces, communities, and patients safe?

COVID-19 testing strategies are being employed to support these efforts worldwide. The two main testing scenarios are real-time PCR to detect the SARS-CoV-2 viral RNA causing COVID-19 infection, and antibody detection assays to identify individuals who have been infected and recovered from the disease. In addition, we can test to further characterize the antibody response to better understand stage of infection, maturation of antibodies, and strength of antibody response.

Testing and monitoring will reduce the spread of COVID-19 and will be critical in getting the country back to work safely. Testing can also support important decision-making for clinical trials. In addition to providing guidance for new vaccine programs targeted specifically at COVID-19, these assays can also support development decisions for therapeutics aimed at other diseases. Many trials have had to be halted or delayed in the wake of COVID-19 quarantines, and now sponsors must consider how patients with antibodies to the virus might impact their clinical trial strategy as they look to restart programs.

As a leading bioanalytical laboratory with a premier diagnostic testing facility, BioAgilytix is uniquely positioned to support both clinical trials and return-to-work surveillance. We understand the importance of being an agile partner to our customers, who are working to keep their science and research advancing in the face of unprecedented challenges. As a member of the business community we also understand that back-to-work screening will be critical to enable business to reopen effectively. That is why we have applied our expertise to offer a full range of COVID-19 testing needs.

Complete COVID-19 Assay Suite for Sponsors
Both viral and serology testing are used to screen patients currently in or about to enroll in clinical trials, and BioAgilytix is able to offer these comprehensive assay capabilities to support sponsors, especially those investigating new therapeutics and vaccines for the treatment and prevention of COVID-19. Further characterizing responses to the virus can also help guide how patient enrollment and management strategies should evolve. Emerging data suggests that patients with severe cases of COVID-19 may experience cytokine release syndrome (CRS) which could represent a significant cause of death. Therefore cytokine monitoring is important in managing patients receiving novel COVID-19 therapeutics, and BioAgilytix can apply our three validated MSD 10-plex cytokine/chemokine panels to quantify these biomarkers specifically related to SARS-CoV-2. Biacore assays can also be used to assess isotype switching to distinguish fresh from later infection and determine antibody maturation.

Supporting Return-to-Work Surveillance
Until a vaccine is available, we must find ways to systematically return employees to work while mitigating the risk of further COVID-19 spread. Employer-driven testing will be one critical element, helping to identify those with active infections of COVID-19 before they enter the workplace, and to also understand the exposure of the workforce to COVID-19.

Through our CLIA-accredited diagnostic testing facility in Boston, BioAgilytix can partner with companies to support their immediate and long-term return-to-work testing and monitoring needs with both viral pathogen and antibody testing. We offer a different approach than the typical large-scale diagnostics lab in that we can help organizations build a complete and customized program that is tailored to their business, helping to determine the appropriate volume and frequency of testing, optimal sample collection and logistics, and ideal reporting formats.

Continuing to Evolve with the Latest Science & Thinking on COVID-19 Testing
Given the many accelerated research efforts focused on COVID-19 disease, science supporting this testing continues to evolve. BioAgilytix is committed to staying at the forefront of these new developments so that we continue to provide expert guidance for biopharma and companies to keep their work on track: whether that means progressing clinical trials or reopening their businesses and offices safely.

BioAgilytix’s team has in fact become a go-to source for information on the latest developments in COVID-19 testing and how they impact research strategies and assay selection. Our Team recently participated in an AAPS eChalk talk on this topic and will be hosting a follow-up webinar with new updates on June 3, 2020. We invite you to join us at 10:00am EDT/15:00 BST for the live event, “The Latest Science & Thinking on COVID-19 Testing”, to hear the latest on COVID-related research and her perspectives. Click here to register!

We’re also here to help if you have questions or COVID-19 testing requirements. Reach out to our scientists here to get started.

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