Last Mile of Molecular Diagnostics in Precision Medicine and Healthcare

Christina Lingham:
Hi, everyone. I'm Christina Lingham from the Next Generation Diagnostic Summit. I'm really pleased to have the opportunity to speak with Bruce Quinn of Bruce Quinn Associates to talk with us about his session on Last Mile of Molecular Diagnostics and Precision Medicine in Healthcare and his latest work in the area. The meeting is taking place on August 22nd through the 23rd in DC.

Bruce, thank you for joining us.

Bruce Quinn:
Thanks for the chance to be on this podcast.

Christina Lingham:
Tell us about yourself and your latest work.

Bruce Quinn:
By my training, I'm an MD PhD and I'm also a board-certified pathologist. For the last 15 years I've worked for the Medicare program as a medical director and I've worked about 10 years as a strategy consultant for a range of laboratories and IVD developers both large and small. Occasionally one of the most interesting things is trying to explain the US diagnostic system, both regulatory and payment to companies in Europe that want to come here. Then, you really have to start from scratch and explain how complicated our system has become.

Christina Lingham:
Can you outline what you consider to be some of the greatest obstacles to implementing precision medicine?

Bruce Quinn:
Yeah. I think there are several different major areas in precision medicine and depending which one you're talking about, it changes what the obstacles are. For example, there are some very specific genes that are targets for certain chemotherapies and generally those have a pretty smooth path with payers. You've got FD approved genes, you've FD approved drugs, so payers aren't really the problem or coding. The main issue is getting access to patients. It's having share of mind with clinicians, as they're so busy and as these options proliferate in oncology. For precision oncology, I think often it's keeping physicians up to date and getting things ordered, because once they're ordered we can get them paid for and delivered.

Another big area is prognostic tests, like the Oncotype DX test for low and high aggressive breast cancer. There's some tests like that also in prostate cancer. Those companies tend to do fairly well also, because they're dedicated to one or a couple tests. They focus on breast cancer or they focus on prostate cancer. They work very closely with sales force, with payers. That's another pathway that works pretty well.

I think the third area I'd mention in precision medicine is potentially equally important but it's a lot harder to develop and that's pharmacogenomics or pharmacogenetics. It's for other classes of drugs. Knowing how they're metabolized, knowing how they're likely to be most effective. That's an area where the problem is, you have generic genes. There's no IP involved. There's codes but often they're not covered by payers. Payers don't want those genetic tests to be overused. Clinicians aren't very aware of them. They may not be in guidelines yet. That scenario that I think is poised to really expand but it hasn't done that yet. With pharmacogenetic tests, I think you have all the problems. You have clinician share of mind as well as coding and payer problems.

Christina Lingham:
What advice do you have for people integrating into the clinic?

Bruce Quinn:
The most important thing that people know now is that it's not just a lab. Just putting a bench top sequencer or a chip assay system in place for pharmacogenetics won't get things done. You have to have a whole runway prepared. That includes things that are pretty far outside the lab, like clinician education and integration with electronic health records or prompting for what test should be ordered next. Just in the last year or two, I think one of the changes is that you hear EHR vendors, like Epic, talking a lot more about making their systems genetics friendly. That's really important. The other thing is, you see that leading institutions are starting to prioritize precision medicine. Geisinger is one, UCS Stanford, University of Chicago, University of Florida, a lot of places. I think we have to get past the era of saying that precision medicine is around the corner and figure out how to make that victory a real thing today.

One of the issues that's challenging we have mentioned yet is bundling of tests into hospital visits or hospital inpatients stays. You might have some genetic tests that are very high value for the patient and the care pathway, but it falls on the internal budget of the lab, because it's almost like part of the overhead of the lab to provide that test, because it's bundled. Even though it's going to benefit the patient and health system years into the future.

Christina Lingham:
One last question. What are some of the most exciting new developments emerging in the field and how has your work changed as a result?

Bruce Quinn:
I think there's more interest now in institutional efforts and really getting all the different players on board. You have programs that are more top down in healthcare systems. Frankly, it might sound surprising, but one of the things that seems to help is if marketing gets interested, right? I discovered recently that Stanford has a dedicated web page for its precision medicine programs and it really touts how far in advance it's getting in precision medicine. UCSF in San Francisco has something like a dean or associate dean for precision medicine. These are indications where it's really a top down effort.

I got a call a couple weeks ago from a three hospital system in the Midwest that I'd not heard of before. They wanted to know how would they set up a precision medicine program and what are some of the things you can think about. There are consulting groups that are now developing to try to help hospitals and health systems implement precision medicine. I think we need to recognize that in many ways, these efforts are not mature yet. There are things we are still figuring out, what the roadmap is going to be and how we're going to accomplish it.

Christina Lingham:
Bruce, thank you so much for talking with us today.

Bruce Quinn:
Thank you.

Christina Lingham:
That was Bruce Quinn of Bruce Quinn Associates. He'll be speaking at the Commercializing Molecular Diagnostics track at the upcoming Next Generation DX Summit this August in DC. Thanks for listening.

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