Proteogenomics represents the integration of proteomics with genomics. On July 31 at the 70th AACC Annual Scientific Meeting & Clinical Lab Expo, AACC and the National Cancer Institute (NCI) will co-host ( 33221 ) Opportunities for Clinical Chemists in Precision Oncology Multi-Omic Clinical Trials, a scientific session that features this exciting new biomedical discipline.

Studies by NCI’s Clinical Proteomic Tumor Analysis Consortium (CPTAC) have spurred recent interest in this field, session co-host Henry Rodriguez, PhD, director of NCI’s Office of Cancer Clinical Proteomics Research, told CLN Stat. This research demonstrated the scientific benefits of using next-generation mass spectrometry (MS) proteomics with next-generation genomics to better decipher cancer biology and its potential to match a patient’s individual tumor to targeted therapies—something that isn’t possible through just one omics approach, Rodriguez said.

“To move forward this emerging field, researchers will need to raise analytical standards to that of the clinical laboratory community. It is for this reason why coordination and collaboration with AACC is important,” he said.

The genesis of this session arose from a collaboration between AACC, NCI, and the Food and Drug Administration (FDA). Since its inception, CPTAC has been grounded in rigor and reproducibility, a foundation that has been solidified through official partnerships with FDA and AACC, Rodriguez said. “Together, numerous projects have been launched on promoting and educating the clinical chemistry community in proteomic standards/technologies to further their application in clinical labs,” he said. One such example is the first mock 510(k) pre-submission for the development of a protein-based multiplexed in vitro diagnostic test.

Rodriguez has worked with Yan Victoria Zhang, PhD, director of the regional toxicology lab at the University of Rochester Medical Center’s Department of Pathology and Laboratory Medicine, to further expand the role of proteomics in a clinical setting. In 2013, he and Zhang teamed on a session that updated AACC members on the progress and remaining challenges of MS-driven clinical proteomics. “My expertise in oncology/precision medicine and hers in clinical laboratory medicine was met with great success, such that we now look forward to organizing similar sessions at AACC annual conferences,” he said.

They’ll be working together again as co-hosts of this session, which will review the following topics:

  1. The use of MS for therapeutic drug monitoring in precision medicine;
  2. Proteogenomic analyses applicable to core needle biopsies in clinical trials to predict therapeutic resistance; and
  3. FDA’s increased consideration of comprehensive multiplexed omics tests.

Presenters for this session include: Nigel Clarke, PhD, vice president, advanced technology at Quest Diagnostics; Karin Rodland, PhD, a lab fellow at Pacific Northwest National Laboratory; and Gideon Blumenthal, MD, acting deputy office director of FDA’s Office of Hematology and Oncology Products.

Attendees following this session will be able to:

  1. Discuss the applications of pharmacogenomics in clinical diagnostics;
  2. Describe the challenges and opportunities in integrating genomics and proteomics alternations in oncology clinical trials and patient treatment;
  3. Understand the potential functions and values of clinical chemists in clinical trials for cancer treatment; and
  4. Grasp FDA regulatory considerations for oncology trials based on genomics and proteomics features.

This scientific session at the 70th AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago will take place July 31 from 2:30 p.m. to 5 p.m. and is worth 2.5 CE hours.