Discussion 5: Companion Diagnostics in Targeted Treatments

Dr Klein moderates this discussion, including co-editor in chief of The American Journal of Pharmacy Benefits Dr Jan Berger. The panel addresses a variety of topics as they relate to companion diagnostics in targeted treatments. Panelists respond to issues such as who should take responsibility in genetic counseling to ensure that patients have the best experience possible—whether it be in person or telephonic. Other topics covered in this discussion include “appropriate consumerism” in this space, the employer’s role in genetic counseling, and how medical professionals are being trained or educated about these processes.

“So, if Bob’s genomic testing shop down the road opens up because the Myriad court case went through, how many of these rogue labs are you going to really trust?” asks Dr Klein. “So, you’ve got quality control problems, so we’ve got analytic validity, and then clinical validity and clinical utility, and Karen [Lewis] talked a lot about clinical utility, and I think that as the tests become not just for people with cancer, but for the United States, then that does open up a can of worms.”

“It is really unchartered water and it’s really scary water because I was talking to a medical director for one of these companies that’s got this NexGen platform and she basically said well, you know, we’re going to expect every American to have this all on a little card or a zip drive and they’re going to walk into the ER and the doctor is going to plug it in and it’s going to inform how the doctor makes decisions about the care for the patient,” Dr Kolodziej says. “So, tell me exactly where we validated that model for care. I don’t get that.”