Emmanuel S. Antonarakis, MBBCh: One of the messages I would like to share with community oncologists is that any day now, we will have clinical grade commercially available AR-V7 testing for people to order throughout the community and throughout the United States. So, at this point in time, we do have a clinical grade CLIA-certified AR-V7 test at Johns Hopkins. That test requires that we receive the blood sample from patients within 24 hours of the blood sample being collected and then we will analyze the result and give a report back to the referring provider. We have done that for more than 1 year now at our Molecular Diagnostic Laboratory at Johns Hopkins.
The second one, which will be a commercial platform, will be developed by Epic Sciences. And in the third quarter of 2017, or at the fourth quarter by the latest, Epic Sciences will launch their own protein-based AR-V7 test as well, which can be ordered by community physicians. And that assay will also be distributed by Genomic Health, which has partnered with Epic Sciences to distribute that AR-V7 assay. So, I think very soon within a few months, and definitely before the end of 2017, there will be at least 2 options for community physicians, who wish to order the AR-V7 test, to order it through the Johns Hopkins Molecular Diagnostics Laboratory. And we have standard operating procedures and shipping procedures on our molecular diagnostics website for anyone who is interested in ordering that. Coming very shortly after that will be the Epic Sciences assay, which will go live, I would say, in the next 3 to 6 months.
Howard I. Scher, MD: When one is thinking about any test that you order for a patient, what we as physicians will think in general is, “How will that test result change what I do for a patient?” So, if you’re at a juncture where you’re not sure what drug to choose, in this particular case with AR-V7, you have a choice with a pill, which is what I call “patient neutral.” “I’m giving you pills. You essentially can go wherever you want, you can take the pills with you. There’s certain monitoring you have to do, but your time is yours.”
If one is starting a chemotherapy regimen, the safety profiles are different and your schedule is different because you need to come to be treated at fixed intervals. I have a number of patients working in New York who would like to travel to Florida, amongst other places, so they’re pretty interested in that, what I call the “patient-neutral approach,” where we essentially change pills. So, those are situations because obviously when a patient is progressing, they’re nervous and they’re anxious. Being able to inform that decision reliably, I think, is really in their best interest. And if you can say to someone that by doing this test that there’s a high likelihood your outcomes will be improved and I can give you the right drug to treat your cancer now, that’s very valuable.
Transcript Edited for Clarity