Panel of Research-Use-Only Mass-Spec Biomarker Tests Launched at AACC 2015

Over 50 research-use-only (RUO) mass-spectrometry based biomarker tests, to be offered as a laboratory service, were launched during the 2015 AACC Meeting & Clinical Lab Expo (July 26–30; Atlanta, GA, USA). The RUO tests are specifically designed for detection and quantification of key protein biomarkers in human serum or plasma and are available to pharmaceutical companies for clinical trials, researchers, and as companion diagnostics.

Nuclea Biotechnologies, Inc. (Pittsfield and Cambridge, MA, USA) highlighted this new service offering available in addition to services from their CLIA/CAP-certified clinical labs.

Companion diagnostics can facilitate development and approval of novel therapeutic drugs and are becoming necessary for successful outcome in many clinical trials. “With the advent of monoclonal antibody and other protein-based drugs, it has become crucial for researchers to access precise companion diagnostic assays for targeted proteins. Mass-spectrometry based tests can selectively detect and quantify protein drug targets at the sequence level,” said Dr. Mary F Lopez, COO and VP of Proteomics Discovery, Nuclea.

Nuclea’s first clinical service laboratory, in Pittsfield, MA (USA), offers an array of fully validated and reimbursable IHC and ELISA tests for various cancer-associated proteins in tissue and blood. Nuclea will launch a second, high-complexity CLIA lab in their Cambridge, MA (USA) facility in late 2015. In addition to IHC and ELISA tests, this lab will offer state-of-the-art mass-spectrometry based multiplexed assays for serum or plasma proteins associated with diabetes, metabolic syndrome, and obesity. “This new service offering is a direct result of our ability to recruit a renowned team of experts in mass spectrometry,” said Patrick Muraca, president and CEO, Nuclea, “We know that biomarkers play a key role in drug development and that there is a market for these services to support clinical research.”

Related Links:
Nuclea Biotechnologies
American Association for Clinical Chemistry (AACC)
AACC 2015 Annual Meeting & Clinical Lab Expo