Streamlined processes afforded by in-house genomic testing have the potential to provide clinical, collaborative, and financial benefits.
Streamlined processes afforded by in-house genomic testing have the potential to provide clinical, collaborative, and financial benefits, according to Lucio N. Gordan, MD, president and managing physician of Florida Cancer Specialists (FCS) & Research Institute, which is set to transition to in-house next-generation sequencing (NGS) in July 2021.
“We have worked really hard in transitioning to in-house NGS testing because we can improve the efficiencies of testing, meaning [we can] capture patients that need to be tested and avoid missed opportunities. Sometimes there may be opportunities that get missed and patients don’t get appropriate testing at the right time, so [in-house testing] will make the flow better,” said Gordan.
In an interview with OncLive®, Gordan, also of FCS Gainesville Cancer Center, discussed the advantages of in-house genomic testing, the transition from external to internal sequencing, and the anticipated effects of the move.
Gordan: We have a very large phase 1/2 clinical research enterprise and for us to have genetic testing available, from a somatic standpoint of the tumor, is critically important so that we can put the patient in the right clinical trials. The evolution of clinical oncology has been so fast lately, with all of the targeted therapies, having a way of getting centralized NGS will be of critical benefit for improved outcomes for patients.
We are planning to activate our molecular laboratory unit about 4 weeks from now*. We will see how well we actually do, but I’m optimistic that we’ll do well. This is a process that has taken more than a year—specifically, 18 months. Analyzing potential partners in the industry, acquisition of the NGS machines and probes and protocols and procedures in itself takes quite a while as there are several vendors. Also, the different vendors in terms of solutions from interpretation of the results standpoint, or the analysis of results that happen in the background is done through another vendor or third party. We have to make sure we’re able to get the tissue to us, extract the DNA/RNA and run through the test, and go through all the validation procedures, which are very laborious and extensive, and then transfer the data to a vendor that helps us analyze the results and get it back to us in a format that the physicians in the frontlines can interpret, read, and discuss with the patient. I’m [quickly] summarizing what it takes 18 months to do, but it’s exciting and fun. We will see how well we have done within the next 3 months or so.
There’s also the angle as far as working with payers and insurances, etc. to make sure that they understand what we’re trying to do. Also, education of our providers is a process, which we’ll be moving towards immediately so we can launch in time.
We have our own pathologists in house, which has been tremendously helpful. I can’t overemphasize how helpful, excellent, and outstanding for patient care it is to have our pathology team in house. They’re able to look at the medical records and analyze case by case and call us with clinical questions. It’s not that they’re just getting a specimen; they have the whole history of the patient at their fingertips and having a dedicated oncologist that can call them back and forth is very helpful. As we develop our own internal processes for pathology, as we add molecular laboratories, we will take this to the next degree of the relationship. It’s a process; we have had pathology for probably 8 to 10 years at FCS. It doesn’t happen overnight.
We are trying and are very hopeful that we’ll be able to avoid test delays or missing reports, because some companies don’t have integration with the electronic medical record. That will be extraordinarily helpful to expedite the results of the test to us, so we can convey [the results] to the patients and get patients on the right therapy, or clinical trial.
From a data standpoint, it will be easier for us to centralize all the results and potentially find patients who may be a candidate for a specific drug in the future, as we have a good catalogue of results from a molecular standpoint and matching with demographics and clinical features or specifics on that patient. These are exciting times in which we will be able to really do a better job in matching the right patient to the right treatment in a faster turnaround time.
In-house testing should expedite the testing time or the turnaround time, which is very important, because a medical emergency [could prompt us to need to] start the right drug for the right patient. There’s also the component of significant anxiety, as we’re waiting for a test that got sent somewhere else, and we can’t get the results, and we don’t have good visibility as to when the results will be back. As we control the process, we’re able to get that information to the patient in a very clear-cut format and enhance patient care. Hopefully, as we launch this in the next few weeks, and we perfect the system, we’ll be able to attract more patients to come to our centers, because they will understand that we have an integrated approach to manage their diagnosis of cancer.
To increase literacy is a challenge, just because the volume of new information is so large. Hundreds of papers are published every week on the subject. Once we launch the platform here, we’ll also deploy some strategies of educating all the providers in molecular biology and cancer care. We already have molecular tumor boards that are done virtually, and we have other types of virtual tumor boards that we will try to match up with the molecular results.
Internally, whenever a new product becomes available for treatment, we educate physicians on the molecular pathways related to that approval, and how that can be important for patient care, potential adverse effects, complications, etc. We try to be very proactive, and this will undoubtedly equal success in terms of a patient’s outcome. It’s about making sure that patients get the best treatment at all times, and that takes more than a village. It takes education, it takes a good laboratory, good information systems, security, and revenue cycle; it’s very complex.
For tissue, usually the turnaround time is 2 to 3 weeks—sometimes 2 to 4 weeks with external vendors. It all depends on where the tissue is, but the time it takes for the tissue to get to the laboratory is anywhere from 10 to 20 days. We hope to get a turnaround time of 7 business days [with in-house testing] by the time we get the tissue, tops, so that should facilitate the [transition] of the molecular results to clinical action.
It absolutely makes a huge difference, not only from a physiological/clinical standpoint, but from a psychological point of view as well.
We think the financial benefits will be positive. We’re working with different payers and an excellent quality of a product to go out and compete with the best laboratories in the world. If we focus on quality, good turnaround time, good reporting, we’ll be able to be financially successful as well. That remains to be seen. The laboratory is launching in a few weeks, and I hope next year you invite me back here to tell the whole story, but it should work itself out.
I always emphasize the teamwork that it takes to set up the infrastructure of such a laboratory. Specifically, molecular pathology, regular pathology, revenue cycle, laboratory personnel, operations, physicians, information technology, security, procurement. It’s cliche, but it does take a huge amount of people to make it happen, and I’m extremely proud of what we have in house.
Editor’s Note: This interview was conducted on June 10, 2021.