A genomic testing cooperative seeks to increase accessibility to genomic profiling across cancers

Genomic Testing Cooperative (GTC) is a diagnostic laboratory that uses a cooperative approach to partner with laboratories, hospitals and oncology practices to improve accessibility to genomic testing for cancer patients, a said Maher Albitar, MD, Founder, CEO and Chief Medical Officer. He added that the comprehensive profiling aspect of GTC’s platform, which uses 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. “Today we can do things we never imagined possible, but we’ve just started to scratch the surface of what genomics can do for us, especially in oncology and precision medicine.

He added that one organization cannot affect the changes needed to introduce genomic testing in every clinic for every patient. This inspired him to build a cooperative organization. “The goal is to create a community of molecular pathologists, oncologists and clinicians in which we all work together to advance science, do better for patients, and capitalize on these advances in genomics. “

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

OncLive®: What unmet needs with genomic profiling does GTC strive to meet?

Albita: One of the main unmet needs is the standardization of how we assess genomic abnormalities. A second is how to link biological and molecular findings to clinical results. [findings] to understand how to extend the use of genomics in everyday practice. Gathering this information is crucial for better practice and better [treatment] of patients, especially in oncology. Of course, the same is true for chronic illnesses.

Although genomic testing is widely used in academia, adoption has been slower in community practices. Why do you think and what steps can be taken to close this gap?

One of the problems is that the information arrives very quickly, [so it’s a challenge] to bring her to a busy community doctor. It is very important to educate oncologists and pathologists in community practice 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 a lot of people think that doing genomics is expensive and that it will add a significant burden to patients, as well as to the health system. In my opinion, the opposite is true. If we do some initial genomic profiling, we can reduce the cost of many tests that may be unnecessary and could be replaced by [broad] genomics [profiling]. Most importantly, we would choose the right therapy for the right patients if we use genomics. This could significantly reduce costs for patients and the healthcare 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 them available to all cancer patients. In current practice, every cancer patient has the right to have [their] cells completely molecularly profiled, that is to say at the level of DNA and RNA. In this way [the patient] can have a full understanding of what’s really going on with them, what the cancer is doing, and the molecular abnormalities present in 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 software that will take advantage of this huge amount of data that we can generate from genomics. Then we can put everything [the data] together and find the best management [strategy] for the sick.

Many people do not understand that genomics can help in diagnosis. [understanding] often complicated presentations and patient situations in which we cannot decipher what is wrong. We can solve this problem with genomics. We can develop information related to prognosis, treatment selection, long-term management, minimal residual disease, other co-morbid factors and even adverse effects of treatment. We can get a lot of information related to these problems that oncologists and patients treat. Genomics can provide this information to help with 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 one of the laboratories belonging to the cooperative groups. It is a perfect example of our company’s mission. We have built a satellite laboratory and [allow providers] to analyze samples as close as possible to the patient. [It can be done] in the same community as the patient, but the data is analyzed remotely with our highly sophisticated analysts trained using multiple AI-based algorithms.

Anthology Diagnostics is the second largest laboratory on the East Coast and a member of the cooperative [group], Key genomics. The key element was our relationship with these 2 laboratories. We share clinical data, in addition to laboratory data. We use clinically relevant information to develop new tests and indications for what we do. [This is critical] for testing to improve patient care and help clinicians make better decisions. We hope to have more examples across 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 keep things simple because science keeps advancing. We have practically 2 classes to test. One relates to hematological diseases and the other to solid tumors. We know that if [a patient has] breast, colon or stomach cancer, there is often significant overlap in terms of biology. However, we do know that hematological diseases are a little different. Therefore, we have 1 test to treat all hematological diseases including lymphoma and leukemia, myelodysplasia, mastocytosis, etc. We make it simple.

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

At the same time, for solid tumors, we have liquid biopsies that can help with diagnosis, as well as patient follow-up. We also have liquid biopsies for hematological diseases. These are first generation liquid biopsies, but we are working on second generation tests which will be available soon. Currently, liquid biopsies are strictly DNA based, so the next generation [tests] will be DNA and RNA. Its very important.

In particular for hematological diseases, we can do a complete immuno-phenotyping with RNA. Its very important. For solid tumors, virtually all of the immunohistochemistry can be done with RNA testing.

What is the Next Generation Sequencing (NGS) internalization process for GTC partners?

We see internalization as a partnership; we are [all] implied. First, we make sure that the volume at our partner justifies the internalization. There is a minimum number of cases that must be inside to justify internalization [of NGS] to be profitable. This also justifies the investment in equipment. We give the partner a list of equipment and help them buy it. We ask them to hire 2 technologists and 1 supervisor between them.

Then we take them to our lab in California and train them on how to perform the tests. We perform cost validation between our laboratory and their satellite laboratory. We help [our partners] to obtain the various certificates required and [to maintain] compliance with local regulations [measures]. We also give them a manual on how to practice taking the tests. We even help them get reimbursed from various insurance companies, as well as Medicare, as it is much easier to get reimbursed for additional tests on a reciprocal basis.

The [partners] can start performing tests in a short period of time, 4-6 months, assuming they have the space available to build the lab.

What recent innovations has GTC implemented or is looking to implement in the near future?

We just announced that our routine solid tumor testing will include any deficiency in homologous recombination. [HRD] inside. [Our partners] no need to order [HRD testing] as a separate test as it is part of genomic DNA and RNA profiling ordered for solid tumors.

We also recently announced that when a person orders the hematologic malignancy test, they will also get the confirmation of the patient’s diagnosis of chronic lymphocytic leukemia. [CLL]. Part of these tests will assess the mutation status of the heavy chains of immunoglobulins, which is relevant for the classification of patients and the treatment of CLL.

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

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