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Precision—not personalized—medicine
March 2011
by Lloyd Dunlap  |  Email the author


SCOTTSDALE, Ariz.— Personalized medicine—or what TD2 president Dr. Stephen Gately calls "precision medicine"—is progressing toward the clinic in research done here by TD2's parent TGen. In recognition of their work, TGen and TD2, its wholly owned subsidiary, have been selected by Avantra Biosciences as a key test site for Avantra's new biomarker quantitation platform, an automated multiplex immunoassay system to evaluate the associations between elevated protein levels, unique patient characteristics and drug responses. The new Q400 Biomarker Workstation and Angio Qx BioChip Immunoassay will enable the rapid measurement of biomarkers that can predict how cancer patients will respond to new drug therapies.
"Avantra's management team has always had a tremendous respect for the business and scientific professionals at TGen," says CEO Brian McKernan. "Through our discussions and strategic brainstorming sessions with Dr. Jeff Trent and Dr. Spyro Mousses at TGen, we were introduced to Dr. Steve Gately, the president of TD2. TGen, TD2 and Avantra Biosciences began discussing several concepts to bring together various genomic and proteomic technologies that would provide researchers, clinicians and pharmaceutical companies with a novel, high-utility offering for the purposes of disease management, drug profiling and patient stratification."  
TD2 (which is short for TGen Drug Development) was particularly attracted to the Avantra system because it can simultaneously measure 10 proteins associated with angiogenesis.   
"Avantra's advanced testing technologies will help scientists speed development of their laboratory discoveries into new therapeutics in a safe and cost-effective manner," Gately says. "Early identification of biomarkers that are associated with drug activity will facilitate a more seamless translation to measure the most appropriate markers for the same drug in the clinic."     
TD2 provides drug development firms with expertise in moving promising laboratory discoveries through the preclinical, clinical and regulatory approval steps of getting new drugs to patients as quickly and safely as possible. Avantra will assist in this process with the commercialization of the new Q400 BioMarker Workstation and the Angio Qx BioChip Immunoassay, which are currently in the alpha, quality-assurance testing phase.  
According to Avantra, the platform offers researchers easy-to-use benchtop multiplex protein tests that deliver rapid quantitative results with very little setup time. The completely self-contained Q400/Angio Qx combination is said to provide quantitative protein biomarker results for 10 analytes in less than an hour, with less than five minutes of sample preparation. Avantra is currently developing additional assays for its QDPx product line that will target specific areas in cancer medicine.  
"TD2 is a leader and change agent in the scientific community's effort to apply innovative molecular analysis technologies to solve challenges in the drug development and oncology fields," says McKernan. "Our collaboration with their outstanding team of professionals is a critical component to Avantra's goal of integrating our QPDx proteomic solutions with novel and cutting-edge molecular profiling technologies."  
Avantra and TD2 are just starting a new project with a large pharmaceutical company to utilize their respective technologies for drug profiling and patient stratification purposes. Gately notes that TD2 is already quietly celebrating precision medicine successes by hoisting "We did it" banners in its headquarters on the Mayo Clinic campus in Arizona. The nonprofit TGen subsidiary has 20 clients that have progressed from early discovery to Phase I testing in humans, and in partnership with Life Technologies, has studied the whole genome of 13 of 15 patients with triple-negative breast cancer.
Triple-negative breast cancer refers to any breast cancer that does not express the genes for estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. This subtype of breast cancer is clinically characterized as more aggressive and less responsive to standard treatment and is associated with poorer overall prognosis. TD2 and Life Technologies are using NGS and bioinformatic analysis to develop personalized drug treatments for the fifteen. In another example of precision medicine, TD2 has identified a biomarker for pancreatic cancer and developed an experimental therapy that has shown benefit in the single patient thus far treated.

8 steps, 10 analytes, 6 replicants  

The process of using Avantra's Q400 Biomarker Workstation and the Angio Qx BioChip Immunoassay in tandem:  
1.      Bring the BioChip, sample diluent and sample to be tested to room temperature.
2.      Turn on the Q400 and insert the BioChip.
3.      Input sample and study information into the Q400 user interface.
4.      Mix 110 µL of sample with 110 µL of sample diluent.
5.      Inject 200 µL of the sample/diluent mixture into the BioChip sample input port.
6.      Press the start button.
7.      The assay proceeds without further user intervention; results are ready in approximately 50 minutes.
8.      The Q400 uses stored standards curves to automatically calculate the  concentration of each of the 10 analytes measured by the AngioGenQ Biochip.
Code: E031113



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