American Association for Clinical Chemistry
Better health through laboratory medicine
San Diego Thrives as Biotech Hot Spot

Special Edition

San Diego Thrives as Biotech Hot Spot
AACC Local Section Addresses Needs of Industry, Clinical Members
By Julie McDowell

For the first time ever, AACC is holding its Annual Meeting and Clinical Lab Expo in San Diego, one of the birthplaces of biotechnology. The city is currently ranked behind San Francisco and New England in boasting the largest number of publicly traded biotechnology companies in the U.S., according to a recent report from Ernst & Young titled Beyond Borders: The Global Biotechnology Report 2007. With biotech giants such as Biogen Idec (Cambridge, Mass.) and Genetech (South San Francisco, Calif), having outposts in the San Diego region, the area is also home to many large and small in vitro diagnostics (IVD) manufacturers, such as Gen-Probe, whose tests screen more than 80% of the nation’s blood supply for sexually transmitted diseases, reports BIOCOM, a life science industry association representing biotech companies in Southern California.

Because biotech has such a large presence in San Diego, many of the 149 members of the AACC local section are from the industry side of laboratory medicine. “Hybritech Incorporated (San Diego, Calif.), formed in 1978, was one of the earliest biotechnology companies in the U.S.,” said San Diego local section Chair Judith Finlay, PhD. “Hybritech introduced innovations to IVD like dual monoclonal antibody immunoassays and the prostate specific antigen test for prostate cancer.”

San Diego is one of the largest biotech hubs nationwide, and there are about 500 small biotech companies in the region, explained another local section member, Ping Gao, MD, who launched the niche IVD company Epitope Diagnostics in the city in 2003. “The San Diego section is unique because many of our members work in industry. Because of this fact, one of our missions is to help local industry members by keeping them up to date on regulatory, research, technology, and clinical innovations.” Other AACC local section members hail from the University of California, San Diego (UCSD) Medical Center and the San Diego Reference Laboratory, as well as hospital and reference laboratories.

Not all of the industry-based San Diego section members work for big companies like Biosite or Gen-Probe; a number staff smaller start-up IVD companies. “There are a lot of new IVD companies that get generated out here,” said Finlay, who has worked for Hybritech and Beckman Coulter (Fullerton, Calif.) in the past, and is now with Gen-Probe. “Innovation happens here quite frequently, so it’s easier to form a company where there is a large pool of qualified employees.”

This innovative drive has long been part of this local section’s momentum. Over 20 years ago, members of the group launched The San Diego Conference to highlight cutting-edge technologies in diagnostic medicine. Now a cornerstone of AACC’s educational efforts in the molecular diagnostics arena, the next meeting will be held in March 2008 (See Box), and will feature a keynote presentation by 2006 Nobel Prize winner Andrew Z. Fire, PhD, head of The Fire Lab at Stanford University School of Medicine in Palo Alto, Calif. Fire won the Nobel Prize for his discoveries in the RNA interference field related to gene silencing.

A Preview of the ’08 San Diego Conference

Genomic Technologies at the Interface of Diagnostics and Therapeutics

March 25–26, 2008
Coronado Bay Resort & Spa, Coronado, Calif.

Keynote Presentation:
RNAi, Other Mechanisms by which Cells and Organisms Respond to Genetic Change, and the Implications of These Mechanisms on Human Disease and Health Care
Andrew Z. Fire, PhD
Stanford University School of Medicine, The Fire Lab

Characterizing and Sequencing DNA in Nanopores
Daniel Branton, PhD
Harvard University, Department of Molecular and Cellular Biology

Developing Molecular Biomarkers for Cancer
David Ransohoff, MD, PhD
University of North Carolina School of Medicine,
Lineberger Comprehensive Cancer Center

MicroRNA Expression Profiling
George A. Calin, MD, PhD
The Ohio State University Comprehensive Cancer Center

Look for additional information to be posted on in the coming months.

Staying Updated

One of the main concerns for anyone working for an IVD manufacturer is current and future changes in federal regulations—whether they relate to how the Food and Drug Administration (FDA) approves tests or revisions to how the Centers for Medicare and Medicaid Services (CMS) reimburses for tests. One regulatory issue of particular concern for many members of the San Diego local section is the FDA’s draft guidance on the regulation of in vitro multivariate assays (IVDMIAs) released in September 2006 (CLN, November 2006). IVDMIAs are a new class of complex test systems that analyze multiple markers and may also use software-driven algorithms to provide diagnostic treatment or guide treatment decisions. “Our local section members think that this is a hot topic and something that is really going to change diagnostics,” said Finlay. “Actually regulating IVDMIAs and making the regulations work is likely going to be very difficult.”

While the FDA often holds public meetings to clarify and hear feedback on their draft guidances, it’s hard for San Diego section members to attend because these meetings are typically held near Washington, D.C. For example, in February, the FDA held near Washington a public meeting on the IVDMIA draft guidance, where the agency heard both support for and concern over efforts to regulate these tests, which officials say inform any changes to the guidance as it progresses to the rulemaking phase (CLN, May 2007). Because many San Diego members can’t get to these public meetings held across the country, they rely on hearing reports at the local section meetings from members who are able to attend. In addition, members also rely on AACC audioconferences, such as the one on IVDMIAs, “What Clinical Labs Need to Know About the New IVD Multivariate Index Assays (MIAs) Guidance,” held on March 15, and “Regulating and Reimbursing Genetic Testing…2007 and Beyond,” held on May 30.

“The IVDMIA issue is something that is definitely of interest to me as the head of an IVD company because this is such a new direction for the FDA,” said Gao.

Valuable Networking Opportunities

In addition to information on regulatory issues, San Diego local section members also find the networking opportunities valuable, as well as rewarding. For many industry members, collaborating with those from research and hospital laboratories is vital to their business. When Epitope Diagnostics was looking to do clinical trials on its enzyme linked immunosorbant assay (ELISA) for the detection of fetuin A, a protein believed to be important in the prevention of cardiovascular calcification, Gao sought help from local section member Paul Wolf, MD, Professor of Pathology at the UCSD School of Medicine. Wolf and his residents helped conduct clinical studies on the assay, as well as publish papers and produce meeting presentations. Epitope’s ELISA kit for fetuin A was cleared by the FDA in 2003.

“Networking with local section members has definitely helped our research and development and other aspects of growing our business,” said Gao. “We talk to people in the local section who have had many years of experience as laboratory directors, and they offer specific advice on how to improve our tests.” This advice has included how to increase specificity and sensitivity of a test as well as what cut-offs to use.

“Talking with local section members also provides information on how our tests can be used in different populations—such as in a hospital lab for both in-patients and out-patients,” he explained, referring to Epitope Diagnostics’ recently cleared, odorless immunochemical fecal occult blood test. “These are two different groups of patients—inpatients might be on antibiotics and have secondary infectious diseases or gastroinstestinal irritation. The sample hemoglobin level might be slightly higher than the normal population, which is generally consistent with the out-patient population.”

Gao explained that all this information gathered from local section members—from regulatory updates to development advice—are vital to the operation of IVD companies. “Some of these things, such as deciding the best cut-off to set for a device, might appear to be small issues, but they play a great role in the decisions made by diagnostic companies,” he added. “In this age, information is so important, which is why it’s so valuable that the local section keeps us updated about what is going on in every facet of laboratory medicine—from regulatory changes to research and development innovations.”