Integrated Diagnostics® Launches Imaging Division to Create PET Imaging Probes

Press Release | 13 June 2012

SEATTLE – Integrated Diagnostics (InDi®), an emerging leader in molecular diagnostics, today announced that the company has launched a new operating division, InDi Imaging™, that is creating a new generation of PET imaging probes using the company’s innovative protein catalyzed capture (PCC) agent technology. PCCs, initially developed for in vitro molecular diagnostics, will be employed as rationally designed, in vivo diagnostic imaging probes that mimic the properties of antibodies and biologics in PET molecular imaging, with the benefit of being chemically stable, synthetic small-molecules.

Concurrently, the company announced that it has appointed Norman Hardman, Ph.D. as the president of InDi Imaging. Dr. Hardman, a well-respected biotechnology executive, has a long track record of successfully commercializing new molecular technologies. The company also announced that Michael Phelps, Ph.D., Norton Simon Professor, chairman of the UCLA Department of Molecular and Medical Pharmacology and the inventor of PET, has been appointed to InDi Imaging as an advisor. Integrated Diagnostics’ other division, InDi Dx™, will continue to focus on in vitro diagnostic medicine. Its first diagnostic test, a blood based protein test for the detection of lung cancer in patients with intermediate size pulmonary nodules, is scheduled for commercial launch in the first half of 2013.

“InDi Imaging is seeking to provide whole body imaging assays with PET of all tissues of the body to examine the primary tumor in cancers and metastases in different organs that are known to have different biological characteristics to supplant more conventional diagnostic modalities through real time imaging with PET using PCC technology,” said Albert “Al” A. Luderer, Ph.D., CEO of Integrated Diagnostics. “Norm Hardman brings a wealth of experience and success in R&D, pharmaceuticals and biotech. I believe Norm is uniquely positioned to lead InDi Imaging as we create a new world of imaging products with PCC technology that are coupled to our in vitro blood based molecular diagnostics.”

PCCs are stable, synthetic, rationally designed chemical compositions with small-molecule like properties designed to detect designated motifs on any target protein through chemical diversity in the PCCs for arrays of protein targets. InDi licensed PCCs from the California Institute of Technology (Caltech). The technology is based on inventions pioneered by Jim Heath, Ph.D., a Caltech and UCLA professor, InDi co-founder and board member. The team at InDi, under the direction of Paul Kearney, Ph.D., the company’s chief scientific officer, is adapting PCCs for in vivo diagnostic imaging applications. PCCs are manufactured using “click chemistry”, a process that allows scientists to join (“click”) together molecular components with unusual precision and stability with high selectivity to the target protein. InDi has obtained a license to use click chemistry from the Scripps Research Institute. The company plans to pursue the first human studies of its PCC-based imaging products over the next 12-18 months.

“PCCs are incredibly versatile because they are built using the principles of modular chemistry. That means they can be optimized for use as in vivo imaging PET probes, enabling us to simultaneously pursue multiple disease targets in a way that is difficult or impossible using more traditional antibody- or phage-display approaches,” said Dr. Hardman. “I am very excited to join Al, Jim, Paul and the rest of the InDi team in developing new imaging products that will be clinically significant and commercially successful. I’m also looking forward to working closely with Dr. Phelps in the application of PCC technology to develop the next-generation of imaging probes with superior performance in PET imaging and informative diagnosis of the biology of disease in patients.”

Dr. Phelps is the inventor of PET, a molecular imaging technique that provides in vivo images of biological processes, blood flow, metabolism, cell communication systems, drug interactions and gene expression. The technology has many important clinical applications in the diagnosis of human disease, and monitoring of therapeutic modalities. There are 2,400 clinical PET imaging centers in America, as well as PET clinical services throughout the rest of the world. While uniquely providing molecular imaging diagnostics of disease, the unique principles of PET have provided its molecular imaging diagnostics in approximately 37 million clinical studies without a single reported complication.

“We are very pleased to welcome Dr. Michael Phelps as an advisor to InDi Imaging,” said Dr. Luderer. “He is an unparalleled scholar and entrepreneur in molecular imaging whose counsel will be essential to the technical and clinical success of PCC technology as an innovative new approach to molecular diagnostic imaging of disease.”

About Dr. Hardman

Prior to joining Integrated Diagnostics, Dr. Hardman was the president and CEO of Oxalis Partners, a strategic consultancy to US and EU biotechnology companies and venture capital firms. He is currently non-executive director of Chelsea Therapeutics, Inc. and has previously held senior management roles in several US-based biotechnology companies, including: president and CEO of Amicus Therapeutics; CEO of the UK Medical Research Council (MRC) Technology Transfer organization; senior VP of technology for Enzon Pharmaceuticals; COO of Onyx Pharmaceuticals; and president and COO of GeneMedicine.

Earlier in his career, Dr. Hardman served as head of R&D at Ciba-Geigy UK and played a central role in the integration of the global R&D organization during the merger of Ciba-Geigy and Sandoz to form Novartis AG, becoming head of UK R&D Operations in the merged entity. He has been involved at various stages in the R&D of several important pharmaceutical products, including: Gleevec, Xolair, Nexavar, Amigal and Plicera.

Dr. Hardman graduated in chemistry from the University of London, U.K., and obtained his Ph.D. in biochemistry, from the University of Manchester. His postdoctoral training included a two-year period as a Medical Research Council fellow, and as a postdoctoral fellow at Harvard Medical School. Dr. Hardman is an honorary professor of medical sciences at the University of Aberdeen, and currently serves as VP of the Aberdeen University Development Trust. He is a fellow of the Royal Society of Chemistry and a fellow of the Institute of Biology.

About Dr. Phelps

Michael Phelps is the Norton Simon Professor and chair of the UCLA Department of Molecular and Medical Pharmacology and director of the Crump Institute for Molecular Imaging.

Dr. Phelps is the inventor of PET imaging technology, which is used in research to study the biological basis of normal organ function in health and the biological transitions to disease and to guide new therapies in academia research and pharmaceutical companies. PET is used in clinical practice in the early detection, characterization and evaluation of the therapeutic responses in cancer, neurological disorders and cardiovascular disease.

Dr. Phelps has received numerous awards and honors, including: the Pasarow Foundation Award, the Rosenthal Foundation Award, the George Von Hevesy Prize (won twice; Von Hevesy won the Nobel Prize for the principles of tracer method), the Sarah L. Poiley Memorial Award, Kettering Prize, General Motors Cancer Research Foundation; the Ernest O. Lawrence Presidential Award, the Paul Aebersold Award, appointment as chair of the Nobel Symposium, election to the Institute of Medicine of the National Academy of Sciences, Enrico Fermi Presidential Award from President Clinton and election to the National Academy of Sciences. He has published 720 peer-reviewed scientific articles and four textbooks.

About Integrated Diagnostics

Integrated Diagnostics’ mission is to build new generations of cost-effective, large-scale molecular diagnostic products for improved diagnosis of complex diseases with high unmet needs. InDi Dx™, the company’s in vitro diagnostic medicine division, is developing complex laboratory-developed molecular diagnostic tests that assist physicians with the early diagnosis of diseases like lung cancerand Alzheimer’s by simultaneously monitoring tens to hundreds of disease molecular markers. Integrated Diagnostics’ other division, InDi Imaging, is creating new generations of in vivo molecular imaging diagnostic products based on a novel class of small-molecule diagnostic imaging probes that mimic the properties of biologics and antibodies using InDi’s protein-catalyzed capture (PCCs) agent technology.

The company, co-founded in October 2009 by systems biology pioneer Dr Lee Hood, is conceptually based on a systems view of disease where pathophysiology arises from disease-perturbed networks of proteins, genes, and other molecules. Investors include InterWest Partners, The Wellcome Trust, and BioTechCube Luxembourg. Foundational intellectual property is exclusively licensed from the Institute for Systems Biology and Caltech. Learn more at

Press ReleaseTori Cox