The company’s diagnostic testing services provide reference labs with specialized testing for a diverse range of clinical sample types, using both FDA-cleared assays and laboratory-developed tests. Performed in its CLIA-certified, CAP-accredited, and New York State-licensed Boston laboratory, assays can be used to diagnose and manage infectious, oncological, metabolic, autoimmune, and neurological diseases. In fact, BioAgilytix recently rolled out comprehensive COVID-19 testing services for employers to support immediate and long-term decision-making needed to mitigate employee exposure to COVID-19.
“When Cambridge Biomedical joined BioAgilytix, we brought with us a premier diagnostic testing lab boasting a 20-plus-year track record of quality and reliability,” said Linda Robbie, Ph.D., Vice President and General Manager, Boston Operations for BioAgilytix. “It presented the perfect opportunity to extend BioAgilytix’s service line to also support reference labs in need of esoteric testing that can be customized to their regulatory and timeline requirements. Today, in the wake of COVID-19, these services are needed more than ever, and so we’ve been committed to integrating the diagnostics arm within and as part of the global BioAgilytix brand.”
“It was important to us to maintain the reputed Cambridge Biomedical name for a time, so customers could gain confidence that through BioAgilytix, they would receive the same level of service and diagnostic testing excellence they’ve always known,” said David Osband, Director/Head, Diagnostics Business Development at BioAgilytix. “We’ve proven that our standard of excellence has not waivered, and by renaming the division to BioAgilytix Diagnostics, we can capitalize on the world-class reputation that BioAgilytix has for quality, scientific rigor, and customer service. I’m looking forward to bringing the BioAgilytix Diagnostics name to the forefront of the diagnostics testing market, as a recognized leader and trusted partner for expedient, accurate, and customizable testing.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area, the Cambridge area of Massachusetts, and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, GLP, and GCP, as well as GMP quality control testing (i.e. product release testing, stability testing, etc.). BioAgilytix also offers diagnostic testing services at its CLIA-certified, CAP-accredited Boston laboratory.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high-quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to many of the top global pharmaceutical and biotech companies. For more information, visit bioagilytix.com.