Genomic Testing Cooperative Seeks to Increase Accessibility to Genomic Profiling Across Cancers

Genomic Testing Cooperative (GTC) is a diagnostic laboratory that utilizes a cooperative approach to partner with laboratories, hospitals, and oncology practices to improve accessibility to genomic testing for patients with cancer, said Maher Albitar, MD, GTC’s founder, chief executive officer, and chief medical officer. He added that the comprehensive profiling aspect of GTC’s platform, which utilizes DNA and RNA, offers broad and affordable testing for patients with solid tumors and hematologic malignancies.

“We are in a very exciting time [with] genomics,” Albitar said. “We can do things today we never thought possible, but we have just started to scratch the surface of what genomics can do for us, especially in oncology and precision medicine.

He added that a single organization can’t affect the changes that are necessary to bring genomic testing into every clinic for every patient. That has inspired him to build a cooperative organization. “The goal is to build a community of molecular pathologists, oncologists, and clinicians in which we all work together to advance the science, do better for patients, and take advantage of these advances in genomics.”

In an interview with OncLive^®, Albitar, the former chief of the leukemia section in the Department of Hematopathology at The University of Texas MD Anderson Cancer Center, discussed the unmet needs with genomic testing that served as the impetus to start GTC, the process of becoming a partner with the organization, and the importance of genomic profiling for all patients with cancer.

OncLive^®: What unmet needs with genomic profiling is GTC working to address?

Albitar: One of the major unmet needs is standardization in how we evaluate genomic abnormalities. A second is how to link the biologic and molecular findings with clinical [findings] to figure out how to expand the utilization of genomics in everyday practice. Putting this information together is crucial for better practice and better [treatment] of patients, especially in oncology. Of course, the same can be applied to chronic diseases.

Although genomic testing is used widely in the academic setting, uptake has been slower in community practices. Why do you think that is and what measures can be taken to bridge this gap?

One of the problems is that the information keeps coming very fast, [so it’s a challenge] to get it to a busy community physician. It’s very important to educate community-practice oncologists and pathologists on the [value of] genomics and molecular analysis, and what it can do for patients.

The second thing, which is also very relevant, is that many people think doing genomics is expensive and that it will add significant burden on patients, as well as on the health care system. In my opinion, the opposite is true. If we do up-front genomic profiling, we can reduce the cost of doing many tests that are maybe unnecessary and could be replaced by [broad] genomic [profiling]. Importantly, we would be choosing the right therapy for the right patients if we use genomics. It could significantly save on costs for patients and the health care system. Of course, more importantly, patients [would] get better care [that way, as well].

How do you define the mission of GTC? What makes it unique?

At GTC, we are trying to democratize genomic and molecular testing by making it available for every patient with cancer. In today’s practice, every patient with cancer has a right to have [their] cells completely molecularly profiled, meaning on the DNA and RNA level. That way [the patient] can have a full understanding of what is really happening with them, what the cancer is doing, and what molecular abnormalities are in the cancer.

At the same time, our mission is innovation. [We want to] use this information in the context of clinical data. [We could] give this data, along with the algorithm, to artificial intelligence [AI] computer-based software that will take advantage of this massive amount of data that we can generate from genomics. Then, we can put all [the data] together and come up with the best management [strategy] for patients.

Many people don’t understand that genomics can help in diagnosis, [understanding] frequently complicated presentations and situations of patients in which we cannot decipher what is wrong. We can address that with genomics. We can develop information related to prognosis, therapy selection, long-term management, minimal residual disease, other comorbidity factors, and even adverse effects of therapy. We can get a lot of information related to these issues that oncologists and patients deal with. Genomics can provide this information to help in the course of the disease.

In March 2021, Hackensack Meridian Health launched Anthology Diagnostics Laboratories in collaboration with GTC. How does this partnership fit into GTC’s mission?

Anthology Diagnostics is 1 of the laboratories that is part of the cooperative groups. It is a prime example of the mission of our company. We built a satellite lab and [allow providers] to analyze the samples closer to the patient. [It can be done] in the same community as the patient, but the data are analyzed remotely with our very sophisticated and trained analysts using multiple AI-based algorithms.

Anthology Diagnostics is the second lab on the East Coast and a member of the cooperative [group], Key Genomics. The key thing was our relationship with these 2 labs. We share clinical data, in addition to laboratory data. We use clinically oriented information to develop new tests and indications for what we are doing. [This is critical] for the tests to improve patient care and to help clinicians make better decisions. We are hoping we will have more examples all over the country with a similar approach.

What types of genomic profiling does GTC offer and how do you decide what is best for patients?

We like to simplify things because the science keeps advancing. We have, practically, 2 classes for testing. One is for the hematologic diseases and the other is for solid tumors. We know that whether [a patient has] breast, colon, or stomach cancer, there is frequently significant overlap in terms of biology. However, we know that hematologic diseases are a little bit different. Therefore, we have 1 test to address all hematologic disease, including lymphomas and leukemias, myelodysplasia, mastocytosis, and so on. We simplify it.

If it is a solid tumor, we have 1 test that includes DNA and RNA; it is a complete analysis. We use RNA to confirm the diagnosis and to give a lot of information about the patient, their immune system, and various abnormalities that we expect to see, such as chromosomal translocations.

At the same time, for solid tumors, we have liquid biopsies that are used to help in diagnosis, as well as in monitoring patients. We have liquid biopsies for hematologic diseases as well. These are first-generation liquid biopsies, but we are working on second-generation tests that will be available soon. Currently, liquid biopsies are strictly DNA based, so next-generation [tests] will be DNA and RNA. That is very important.

Particularly for hematologic diseases, we can do complete immuno-phenotyping with RNA. That is very important. For the solid tumors, we can practically do all immunohistochemistry with RNA testing.

What is the process for internalizing next-generation sequencing (NGS) for partners of GTC?

We think of the internalization as a partnership; we are [all] involved. First, we make sure that the volume in our partner justifies internalization. There are a minimal number of cases that must be inside to justify the internalization [of NGS] to be cost effective. This also justifies the investment in equipment. We give the partner a list of the equipment and we help them to purchase it. We ask them to hire 2 technologists and 1 supervisor between them.

Then, we bring them to our laboratory in California and train them on how to perform the testing. We do cost-validation between our laboratory and their satellite laboratory. We help [our partners] to obtain the various required certificates and [to maintain] compliance with local regulatory [measures]. We also give them a manual on how to practice doing the testing. We even help them in submitting for reimbursement from various insurance companies, as well as Medicare, because it is much easier to get reimbursement for further testing with reciprocity.

The [partners] can start performing testing within a short period of time, 4 to 6 months, assuming they have the space available to build the laboratory.

What are some recent innovations GTC has implemented or is seeking to implement soon?

We just announced that our routine solid tumor testing will include any homologous recombination deficiency [HRD] in it. [Our partners] don’t have to order [HRD testing] as a separate test because it is part of the DNA and RNA genomic profiling ordered for solid tumors.

We also recently announced that when someone orders the hematologic malignancy test, they will also obtain confirmation of the patient diagnosis of chronic lymphocytic leukemia [CLL]. Part of that testing will be evaluating immunoglobulin heavy chain mutation status, which is relevant for patient classification and treatment of CLL.

We are spending a lot of time on improving liquid biopsies by integrating DNA and RNA. That is based on our initial data in both sensitivities, which provides tremendous information on hematologic disease on immunophenotyping, for example. [This may allow us] to predict what disease [a patient has] and make a diagnosis more accurately with liquid biopsies.