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Pharma Newsletters >> Eurofins BioPharma Services Newsletter 21 - October 2018 >> Improving Patient Care

Innovative, specialised testing from Viracor Eurofins helps biopharma companies and healthcare professionals improve patient care

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By Jenni Miller, Viracor Eurofins, Director of Marketing

As a specialty laboratory with over 30 years of experience and more than 2,500 validated tests in the areas of molecular and infectious disease, allergy/ hypersensitivity, and immune response monitoring, Viracor Eurofins helps biopharma companies and hospitals with innovative testing to support clinical trials and evolving clinical diagnostic needs.

One such example is a new cytomegalovirus (CMV) gene sequencing assay for resistance to letermovir, the most recent FDA-approved CMV antiviral for use in adult Hematopoietic Stem Cell Transplant (HSCT) patients. While there has been no resistance identified in treatment-naive patients, clinical trials have shown resistance can develop in UL56 after exposure for some HSCT patients. Laboratory testing is recommended to quickly confirm the occurrence of resistance, as treatment modification based solely on clinical suspicion may result in added toxicity and increased time and complexity in patient management, if resistance is present in the patient.

The CMV Resistance: Letermovir sequencing assay, made commercially available in May 2018, is designed to detect identified mutations in the UL56 genes of CMV. The use of genotypic sequencing offers a rapid turnaround time, a broad range of antiviral resistance information, and the ability to provide information concerning new drugs as they become available.*

The newest assay is available as a standalone test or as a complete panel that includes the other CMV antiviral drugs ganciclovir, foscarnet and cidofovir. The panel is designed to detect identified mutations in the UL54, UL56 and UL97 genes of CMV. These new assays add testing options that help physicians across the continuum of care for immunocompromised patients.

In addition to clinical testing innovations, Viracor Eurofins partners with biopharmaceutical companies to help with complex assay design/transfer, optimisation and validation of assays to support the needs of study protocols.

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*Kotton, C. N., Kumar, D., Caliendo, A. M., Åsberg, A., Chou, S., Danziger-Isakov, L., & Humar, A. (2013). Updated International Consensus Guidelines on the Management of Cytomegalovirus in Solid-Organ Transplantation. Transplantation Journal, 96(4), 333-360. doi:10.1097/tp.0b013e31829df29d