The Bioanalytical Laboratory Can Now Perform Testing that is Subject to CLIA Oversight

OCTOBER 22, 2019—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has received its Certificate of Registration from the Clinical Laboratory Improvement Amendments (CLIA) program regulated by the Centers for Medicare & Medicaid Services (CMS) for its U.S. facility in Durham, NC. Because CLIA requires a laboratory to perform on-site testing prior to being fully accredited, this certificate enables BioAgilytix to conduct nonwaived testing on human specimens for the purpose of health assessment or for the diagnosis, prevention, or treatment of disease until it is inspected by a CMS-approved accreditation agency to confirm its compliance with CLIA regulations. BioAgilytix is currently enrolled to be surveyed for accreditation by the Commission on Office Laboratory Accreditation (COLA) in the coming months.

The CLIA certificate confirms that BioAgilytix is now able to perform lab-developed tests in the diagnostic immunology specialty that are deemed “high complexity” and subject to CLIA oversight, such as ADA, NAb, and biomarker assays used to determine patient inclusion and exclusion criteria for trial enrollment. This also includes studies that involve reporting of patient-specific results that can or will be used to affect the care or treatment of a patient, such as data to gauge dosing for individuals among the standard dosing of a general study population.

“We are excited to now offer our customers bioanalytical testing services under CLIA, and give them the confidence that their clinical studies will follow all critical CLIA regulatory standards and requirements,” said Natalie Smith, BioAgilytix’s CLIA Laboratory Director. “This certificate gives us immediate capability to provide patient-specific data that will help our clients make pivotal decisions regarding drug safety, dosing, and inclusion/exclusion criteria for patient enrollment in clinical trials. Patient-specific reporting is particularly important when supporting gene therapy programs and the development of personalized medicines – both areas where many of our customers are putting more focus. We’re dedicated to ensuring our quality standard remains exceptional and continues to rise to meet the needs of our clients, and our CLIA certification is the latest example of that commitment.”

###

About BioAgilytix

BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area 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.).

The Bioanalytical Laboratory Achieves Exclusive Ranking for a Seventh Time

OCTOBER 14, 2019—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has been named by Triangle Business Journal as a Fast 50 Award winner for 2019, marking the seventh time the organization has been recognized as one of the fastest growing privately held companies in the Triangle Park area. The Fast 50 Awards celebrate companies that have exhibited remarkable growth in the past three years and honor their contributions to creating new jobs and stimulating cash flow in their community. Previously included on the Fast 50 list in 2018, 2017, 2016, 2014, 2013, and 2011, BioAgilytix has continued to methodically grow its capacity and team to meet the rising demand for large molecule bioanalysis and efficiently serve the biologic development needs of pharmaceutical and biotechnology companies worldwide.

“I could not be happier for our team’s efforts to be recognized because they are the ones that have enabled BioAgilytix to become the premier bioanalytical services provider it is today,” said Jim Datin, President and Chief Executive Officer of BioAgilytix. “Our reputation for quality science and committed service have had a huge impact on our growth as both existing and new customers have the confidence to place more critical studies in our capable hands. In 2018, we supported 8 of the 18 large molecule drugs that were approved by the FDA – a huge testament to our team’s ability to meet our customers’ study demands efficiently and with the quality required to accelerate needed therapeutics to market.”

This past July, BioAgilytix completed a new expansion to its Durham, NC campus which grew the facility footprint an additional 21,173 square feet to accommodate its growing team and additional testing services for biologicals including cell and gene therapeutics. “We’re proud to have our US headquarters located in RTP and to have been a part of the Triangle’s growth for more than 10 years,” added Datin. “Its reputation as an innovation hub has been key in our recruitment efforts, giving us a great talent pool to source from as well as the ability to attract individuals outside of our region to join this vibrant scientific community.”

BioAgilytix will receive its list ranking with the other 2019 Fast 50 winners at an awards dinner to be held on November 20, 2019 at the Raleigh Convention Center in Raleigh, North Carolina.

###

About BioAgilytix

BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area 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’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.

Media Contact:
Jennifer Absher
BioAgilytix
(919) 287-1573
media@bioagilytix.com