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Creating Companion Diagnostics with Biomarkers

Thu, 02/14/2013 - 2:40pm
Mike May, PhD, Contributing Editor
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At Insight Genetics, vice president of research and development David Hout, PhD, and his colleagues use biomarkers in the development of companion diagnostics. (Source: Insight Genetics)

For anyone wondering about a key pharmaceutical change, consider these words from JonEric Pettersson, manager of commercial development at Insight Genetics (Nashville, Tenn.): “Less than 1% of current drugs have a companion diagnostic, and 60% of the drugs in clinical trials have a companion diagnostic in mind.” He adds, “Companion diagnostics are an important component in moving the ball forward in personalized medicine.” Making those moves depends on biomarkers.

Insight Genetics covers the entire process of bringing companion diagnostics from concept to realization. The company works with partners to discover and characterize biomarkers, and design, develop, and refine assays. For pharmaceutical companies, Insight Genetics can help specify the oncogenic drivers inhibited by a new drug target and identify the patients for whom the drug will be most effective. 

Furthermore, Insight Genetics has opened a CLIA (Clinical Laboratory Improvements Amendments)-certified laboratory. “With this facility,” says Pettersson, “we can meet the growing unmet need of resistance monitoring for cancer treatments. We also can support pharmaceutical companies as a central testing lab, running all the testing for clinical trials.” The lab test menu will initially be focused on lung cancer, offering quantitative PCR (qPCR) assays focused on various genes, including the ones for anaplastic lymphoma kinase (ALK), epidermal growth factor receptor, and others, as well as next-generation sequencing services.

When developing a companion diagnostic for a particular drug, says Eric Dahlhauser, CEO at Insight Genetics, the company’s researchers rely on qPCR because of the advantages it offers over other techniques. “Going forward, multiple biomarkers will be used in a companion diagnostic, and qPCR can be adapted to a multiplex platform,” he says. “Plus, there’s no need for interpretation, because you get a yes or no answer.”

“Every step of our assay development program is synchronized to support the clinical trials and FDA approval of cancer therapeutics,” said Pettersson. As an example, he explained work on an ALK biomarker, a promising target for a novel class of lung cancer drugs. Insight Genetics is currently partnering with QIAGEN (Hilden, Germany) to make the Insight ALK Screen available worldwide. The companies are collaborating on clinical validation of the test, which QIAGEN will market as a companion diagnostic. In addition, Insight Genetics licensed the assay to GE Clarient (Aliso Viejo, Calif.) for use as a lab-developed test. 

Collaborations such as these make all the difference in developing powerful companion diagnostics based on biomarkers.

Further FISHing

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Gastric cancer stained with Dako’s HER2 IQFISH pharmDx. Tumor cells show HER2 non-amplified heterogeneous mosaic signal distribution. (Source: Dako)

Dako (Glostrup, Denmark), an Agilent Technologies company, measures DNA, RNA, and protein in tissue as potential biomarkers. This company developed the first immunohistochemistry-based companion diagnostic, HercepTest, which was FDA approved in 1998 to measure the expression of the HER2 protein when prescribing HER2-targeted treatments for breast and gastric cancers.

Recently, Dako released its HER2 IQFISH pharmDx kit. According to Hans Christian Pedersen, a principal scientist at Dako, “IQ stands for ‘instant quality,’ because we reduced the turnaround time without compromising the quality of the stain.” In fact, this kit reduces the time required to run the FISH assay from 18 to 20 hours to just 3.5 hours, and it was recently approved by the U.S. Food and Drug Administration as a companion diagnostic for HER2-targeted therapies in breast and gastric cancer. “We will broaden this technology to a number of gene targets,” Pedersen says. Beyond being faster, IQFISH is non-toxic, because it replaces a dangerous formamide buffer with ethylene carbonate.

By speeding up assays, physicians can more quickly start treating cancer patients with the targeted agents, potentially leading to better outcomes for patients.

About the Author
Mike May is a publishing consultant for science and technology based in Houston, Texas.

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