Cambridge, MA – Nuclea Biotechnologies, Inc. today announced that it will begin offering more than fifty research use only (RUO) mass spectrometry-based biomarker tests as part of their laboratory services. At the American Association of Clinical Chemistry (AACC)’s annual conference, Nuclea will highlight their new service offering available in addition to their CLIA/CAP certified labs.

Mass spectrometry-based tests can offer enhanced sensitivity, selectivity, reliability, precision, and quantification when compared to traditional tests. The RUO tests are specifically designed for the 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.

Companion diagnostics can facilitate the rapid development and approval of novel therapeutic drugs and are becoming necessary for a successful outcome in 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 at Nuclea.

Nuclea established its first clinical service laboratory in Pittsfield, MA registered under the Clinical Laboratories Improvement Amendments (CLIA) in Massachusetts and New York and certified by the College of American Pathologists (CAP). The Pittsfield CLIA lab offers an array of fully validated and reimbursable IHC and ELISA tests for cancer-associated proteins in tissue and blood.

Nuclea will launch a second, high-complexity CLIA lab in their Cambridge, MA 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 of 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.”

Nuclea will be featured at booth number 417 during AACC.

Nuclea Biotechnologies, Inc. is located in Pittsfield and Cambridge Massachusetts. Nuclea develops and commercializes unique diagnostic tests for breast, prostate and other cancers, as well as for diabetes and other chronic diseases leading to novel companion diagnostics for the pharmaceutical and biotechnology industries. Nuclea is at the forefront of proteomics, a more precise, personalized way to monitor chronic disease. https://www.nucleabio.com