SCOTTSDALE, Ariz.—Personalized medicine—or what TD2president Dr. Stephen Gately calls "precision medicine"—is progressing towardthe clinic in research done here by TD2's parent TGen. In recognition of theirwork, TGen and TD2, its wholly owned subsidiary, have been selected by AvantraBiosciences as a key test site for Avantra's new biomarker quantitationplatform, an automated multiplex immunoassay system to evaluate the associationsbetween elevated protein levels, unique patient characteristics and drugresponses. The new Q400 Biomarker Workstation and Angio Qx BioChip Immunoassaywill enable the rapid measurement of biomarkers that can predict how cancerpatients will respond to new drug therapies.
"Avantra's management team has always had a tremendousrespect for the business and scientific professionals at TGen," says CEO BrianMcKernan. "Through our discussions and strategic brainstorming sessions withDr. Jeff Trent and Dr. Spyro Mousses at TGen, we were introduced to Dr. SteveGately, the president of TD2. TGen, TD2 and Avantra Biosciences begandiscussing several concepts to bring together various genomic and proteomictechnologies that would provide researchers, clinicians and pharmaceuticalcompanies with a novel, high-utility offering for thepurposes of disease management, drug profiling and patient stratification."
TD2 (which is short for TGen Drug Development) wasparticularly attracted to the Avantra system because it can simultaneouslymeasure 10 proteins associated with angiogenesis.
"Avantra's advanced testing technologies will helpscientists speed development of their laboratory discoveries into newtherapeutics in a safe and cost-effective manner," Gately says. "Earlyidentification of biomarkers that are associated with drug activity willfacilitate a more seamless translation to measure the most appropriate markersfor the same drug in the clinic."
TD2 provides drug development firms with expertise in movingpromising laboratory discoveries through the preclinical, clinical andregulatory approval steps of getting new drugs to patients as quickly andsafely as possible. Avantra will assist in this process with thecommercialization of the new Q400 BioMarker Workstation and the Angio QxBioChip Immunoassay, which are currently in the alpha, quality-assurancetesting phase.
According to Avantra, the platform offers researcherseasy-to-use benchtop multiplex protein tests that deliver rapid quantitativeresults with very little setup time. The completely self-contained Q400/AngioQx combination is said to provide quantitative protein biomarker results for 10analytes in less than an hour, with less than five minutes of samplepreparation. Avantra is currently developing additional assays for its QDPx productline that will target specific areas in cancer medicine.
"TD2 is a leader and change agent in the scientificcommunity's effort to apply innovative molecular analysis technologies to solvechallenges in the drug development and oncology fields," says McKernan. "Ourcollaboration with their outstanding team of professionals is a criticalcomponent to Avantra's goal of integrating our QPDx proteomic solutions withnovel and cutting-edge molecular profiling technologies."
Avantra and TD2are just starting a new project with a large pharmaceutical company to utilizetheir respective technologies for drug profiling and patient stratificationpurposes. Gately notes that TD2 is already quietly celebrating precision medicinesuccesses by hoisting "We did it" banners in its headquarters on the MayoClinic campus in Arizona.
The nonprofit TGensubsidiary has 20 clients that have progressed from early discovery to Phase Itesting in humans, and in partnership with Life Technologies, has studied thewhole genome of 13 of 15 patients with triple-negative breast cancer.
Triple-negative breast cancer refers to any breast cancer that does notexpress the genes for estrogen receptor (ER), progesterone receptor (PR) orHer2/neu. This subtype of breast cancer is clinically characterized as moreaggressive and less responsive to standard treatment and is associated withpoorer overall prognosis. TD2 and Life Technologies are using NGS andbioinformatic analysis to develop personalized drug treatments for the fifteen.In another example of precision medicine, TD2 has identified a biomarker forpancreatic cancer and developed an experimental therapy that has shown benefitin the single patient thus far treated.
8 steps, 10 analytes, 6 replicants
The process of using Avantra's Q400 Biomarker Workstationand the Angio Qx BioChip Immunoassay in tandem:
The process of using Avantra's Q400 Biomarker Workstationand the Angio Qx BioChip Immunoassay in tandem:
1. Bringthe BioChip, sample diluent and sample to be tested to room temperature.
2. Turnon the Q400 and insert the BioChip.
3. Inputsample and study information into the Q400 user interface.7. Theassay proceeds without further user intervention; results are ready in approximately50 minutes.
4. Mix110 µL of sample with 110 µL of sample diluent.
5. Inject200 µL of the sample/diluent mixture into the BioChip sample input port.
6. Pressthe start button.
8. TheQ400 uses stored standards curves to automatically calculate the concentrationof each of the 10 analytes measured by the AngioGenQ Biochip.
