A Medical Device Daily

Pacific Biometrics (PBI; Seattle) reported the launch of Clinical Biomarker Services, a new area of specialty testing services for clinical drug development. Designed primarily to support clinical development of biotherapeutics, the new services will include validation of ligand-binding assays for immunogenicity testing and novel biomarkers in a regulatory-compliant laboratory environment. These new specialty biomarker services will be supported by investments in new instrument platforms for electrochemiluminescence- and multiplex-based testing.

The new specialty services for biotherapeutics will open new markets for PBI in biopharmaceutical and biotech companies, and will broaden the specialty central lab services PBI has provided for the past 18 years, the company said.

Announcing this new initiative, Ron Helm, CEO of Pacific Biometrics, said, "We are extremely excited about launching a significant new area of testing services at PBI. We are seeing the continued evolution of clinical drug development towards increased reliance on novel biomarkers to guide development and improve the safety and efficacy of novel drugs. The provision of clinical biomarker services requires a high level of scientific expertise and a thorough understanding of ligand-binding assays, which PBI has demonstrated consistently since it was founded in 1989. We will also begin providing immunogenicity testing services, which is a specific requirement for biologic drugs and represents an area of growing demand."

Helm continued, "The company is fully committed to becoming a significant player in outsourced clinical biomarker services and we expect to see substantial growth in backlog and revenues associated with these services in the medium and long term."

PBI provides specialized central laboratory and contract research services to support pharmaceutical and diagnostic manufacturers conducting human clinical trial research.