Empowering the Practice of Personalized Medicine: The Evolving Role of Pathology in Cancer Diagnostics

Interview with the Innovators

An Interview With Pranil K. Chandra, DO

PathGroup is a diagnostic and clinical service company providing comprehensive anatomic, clinical, and molecular pathology services. They are committed to providing diagnostic expertise, precision technologies, and innovative services to give physicians and their patients personalized information for targeted therapies that lead to the best possible patient outcomes.

PathGroup works with individual and contract research partners in developing platforms for improved molecular intelligence. Their molecular diagnostics facility includes a dedicated Clinical Laboratory Improvement Amendments–validated laboratory and a full menu of molecular testing options. Through their collaboration with GenoSpace and Thomson Reuters, they offer their new assay PathGroup SmartGenomics Next-Generation Sequencing (NGS), providing information on genes, gene variants and their therapeutic implications, and place diverse real-time data into clinically actionable context for oncologists and researchers. Further, PathGroup SmartGenomics NGS provides a decision support tool for identifying not only potential treatments and clinical trial opportunities for patients but also elucidation on why previous therapies may have failed and forward-looking intelligence on new therapeutic agent targets.

PMO had the pleasure of speaking with Dr Pranil K. Chandra at PathGroup about the changing role of the pathologist in personalizing care, the responsiveness of pathology as a discipline to cancer care needs, and the future goals of PathGroup.

PMO The practicing oncologists who read Personalized Medicine in Oncology are constantly learning about innovations in personalized medicine techniques and how to implement them into their practices. From that perspective, it is useful to provide optimal clarity about how pathology and hematopathology help drive the spread and adoption of personalized medicine in oncology. Could you please describe the role of pathology laboratory services and your mission at PathGroup in this iterative progression of personalized medicine?

Dr Chandra Pathology is undergoing a transformative change, especially in cancer diagnostics. Integrating molecular information into our testing is now critical to provide information to our clinicians that yield diagnostic, prognostic, and/or therapeutic utility. As the director of molecular pathology services at PathGroup, I provide clinical and administrative leadership to our molecular operations that deliver comprehensive and world-class molecular testing to our clients and empower the practice of personalized, precision medicine. The literature now clearly shows that these efforts add value, lead to better patient outcomes, and decreased healthcare costs and burden. In fact, information from pathology laboratories drives more than two-thirds of clinical management decisions and accounts for less than 5% of total healthcare costs.

PMO PathGroup’s capabilities – consisting of laboratory work, oncology diagnostics, specialized PathGroup applications and technologies – are too extensive to cover in 1 interview. What areas would you like to focus on to provide practicing oncologists insights into the role of pathology in galvanizing personalized medicine in cancer care, and what are some significant advances that you would like to describe?

Dr Chandra We have invested in both NGS and array comparative genomic hybridization to maximize the likelihood of identifying actionable genomic alterations and being mindful of the resulting immense amount of genomic data that will be produced. Through our partnership with GenoSpace and Thomson Reuters, we have developed customized tools that allow clinical genomicists in our molecular pathology practice to interpret genomic changes based on what exists in regularly curated genomic knowledge databases in a robust and scalable fashion. These tools allow us to distill the findings to clinically actionable decision points and produce molecular reports that are educational, lucid, and interactive.

PMO How can practicing oncologists retain a working knowledge of innovations in pathology amidst the growth of personalized medicine on the pathology laboratory front?

Dr Chandra It is becoming increasingly difficult to keep up with the rapid advances in genomic medicine and molecular oncology. To address this, we have recently launched an interactive physician portal that functions to educate community-based oncologists on the latest developments in precision oncology and to support scientifically driven clinical decision making. We have also developed online tools and webinars, which are available to physicians and healthcare providers both internal and external to our organization.

PMO What has been your focus or mission for making pathology responsive to cancer care needs?

Dr Chandra The division of molecular pathology services has 3 main goals for 2014. The first is to establish a national reputation for our efforts. We continue to form strategic partnerships and engage in projects that build a quality reputation and brand in molecular testing, which we promote as “SmartGenomics.” SmartGenomics testing includes advanced molecular tumor profiling such as NGS and/or microarray. The second is to overlay these cutting-edge and advanced onco­genomic diagnostic tools in a manner that allows a comprehensive and complementary analysis of cancer tissue. At times certain genomic aberrations may be missed by one technology, and this entails utilizing additional tests in a responsible fashion. Protein overexpression is a prime example that may require a test known as immunohistochemistry to be utilized in conjunction with NGS and cytogenomic microarray (aCGH). The third is to build an infrastructure to efficiently manage the enormous amount of genomic information that will result from our testing and both aggregate and integrate those findings in a lucid summary report. This is the reason for our partnership with GenoSpace and Thomson Reuters.

PMO Can you elaborate on the partnership between PathGroup, GenoSpace, and Thomson Reuters?

Dr Chandra GenoSpace has helped us develop cutting-edge tools to interpret genomic changes and produce a state-of-the-art, dynamic molecular pathology report. Thomson Reuters is an industry leader in providing life science information. Thomson Reuters also has a rapidly growing presence in personalized medicine and has a burgeoning role in the development and maintenance of genomic knowledge databases. As pathologists and laboratory professionals, we are in the business of generating an enormous amount of valuable information. Therefore, the partnership with GenoSpace and Thomson Reuters is a powerful one, bolstered by complementary synergies across and between our respective organizations.

PMO What are your customers’ chief priorities, and how have you focused your energies to meet them?

Dr Chandra We have been laser focused on achieving industry-leading turnaround times to deliver testing results for the most timely patient management and therapeutic intervention and have put in place numerous operational efficiencies to facilitate this. Having timely results is imperative to help our clients manage cancer patients.

PMO How large is PathGroup relative to other pathology laboratory firms?

Dr Chandra PathGroup is composed of more than 70 pathologists and 1000 employees and is one of the largest privately owned pathology laboratories in the country. We are based in Nashville, TN, and provide comprehensive anatomic, clinical, and genomic services to more than 90 hospitals and 2000 physician offices in the country. Our size and structure allow us to provide the most sophisticated testing for our clients while maintaining a direct and personalized relationship. Over the past few years, PathGroup has experienced significant and rapid growth, and through it, we’ve continued to achieve optimal efficiencies and maintain a “team-based” culture of innovation. In 2012, we performed more than 5 million laboratory tests.

PMO Are there any particular impediments to pathology laboratory diagnostics arising from different healthcare sectors: clinical, research, payer coverage, and/or government policy?

Dr Chandra Currently, molecular testing is not reimbursed at a level that is commensurate with the resources and expertise required to deliver the testing or the immense value brought to the healthcare system. Given the enormous excitement behind personalized medicine, hopefully this will change in the near future. Equally important is the responsibility to make sure we oversee and utilize the right tests at the right time.

PMO Conversely, are there examples of these healthcare sectors assisting in advances in pathology, bringing about new efficiencies servicing oncologists and their patients’ needs?

Dr Chandra All stakeholders involved in genomic testing need to build the infrastructure to manage the data. There are a number of bioinformatics companies that are facilitating efficient management of genomic information. We feel that GenoSpace is an emerging leader in this field and is poised to be a significant national player.

PMO What changes in these sectors’ systems and policies would you like to see?

Dr Chandra We need to gravitate toward a policy that focuses on reimbursement derived by the value brought to the healthcare system, which can be determined by a number of factors including outcome and decreased costs.

PMO What systems changes are dealing with inconsistency in biomarker validation? What progress has occurred over the past 5 years?

Dr Chandra There has been a general explosion in genomic discoveries and uptake in the appropriate utilization of molecular testing that has largely been due to an unprecedented rate of publications that implicate new biomarkers and others that continue to establish clinical utility.

PMO Are there any inherent factors impeding further progress?

Dr Chandra Standardization of molecular testing is very important to ensure that the data produced by one organization can be reproduced by another. The second is education of various stakeholders on the value of molecular testing. These are both enormous infrastructural efforts required to drive the progress of precision oncology.

PMO What are the most significant unmet needs for oncologists and patients that PathGroup has worked on, and is working on, to meet?

Dr Chandra Delivery of academic-caliber molecular testing to community-based physicians and oncologists. Approximately 80% of cancer patients are cared for in the community. Our organization is striving to bring the best and most comprehensive oncology testing to them.

PMO Finally, what is on the horizon at PathGroup?

Dr Chandra We are expanding our precision oncology offering to focus on tests that lead to actionable decisions. To this end, we will be bringing up 20 to 30 tests in the next 1 to 2 years. Some of these include single-gene tests that have prognostic or therapeutic impact in the management of cancer patients. Others are more expansive and include analysis of multiplex panels of genes at once through NSG and/or aCGH. We have recently released a 75+ gene panel that uncovers genomic aberrations across a wide spectrum of hematologic disorders with high sensitivity and industry-leading turnaround time. This test will be complemented with aCGH to look for copy number alterations (amplification, deletions, and genomic instability) to maximize the number of actionable genomic aberrations identified, which should lead to increased therapeutic options including clinical trials, decreased healthcare costs, and improved patient outcomes.

PMO Thank you so much for your time today.

Dr Chandra My pleasure.

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