Spotlight on a CRO: Interview with the Team of Scientists behind NeoGenomics Pharma Services

NeoGenomics is a cancer diagnostics and pharma services company serving pharmaceutical companies and academic centers. They specialize in diagnostic, prognostic and predictive testing using the most innovative technologies.

The company opened its doors in 2002 in Fort Myers, FL, and is characterized by a diverse and highly qualified senior leadership team advised by a board of international doctors and scientists. No wonder they recently expanded their capabilities outside the United States, outfitting laboratories in both Switzerland and in Singapore.

True to their reputation as a company that helps get the newest technological advances in front of oncologists and oncology researchers, NeoGenomics has partnered with NanoString to bring the robustness, reproducibility, and flexibility of the NanoString nCounter® Analysis System to NeoGenomics Pharma Services.

It was a real pleasure to interact with this team of enthusiastic and passionate scientists as they shared their experiences with the NanoString services offered at NeoGenomics.

NS: Since your first facility opened in 2002, you have vastly expanded your biopharma capabilities and service model across multiple sites, which speaks to leadership oriented around constant innovation and growth that can be challenging in this ever-changing business environment. What do you think are the winning leadership characteristics that have made NeoGenomics a successful full-service biopharma services CRO throughout each stage of the company’s growth?

NeoG: The leadership at NeoGenomics is patient-focused. Our leadership team is informed, decisive and focused on profitable growth. Each year they meet to discuss and decide upon the main objectives of the company for the following year and longer term and lay those objectives out in a company-wide focus chart. These objectives and the plan for execution with updates on our progress are regularly assessed and most importantly communicated to the NeoGenomics organization.

As a service business that ultimately serves patients and their care, the most important differentiator is the value that NeoGenomics places on our employees. Our people are at the heart of everything we do – they define who we are and how we work – both inside and outside the workplace. Our core values are: Quality, Integrity, Accountability, Teamwork, and Innovation. Our leadership lives and exemplifies these values. Our employees demonstrate the behaviors of our values through their performance, attitude, and actions. Communication and most importantly listening to the employees as well as our customers are key to aggressive execution and maintaining innovation in a constantly changing and developing landscape. NeoGenomics has been serving the cancer community for over 17 years, and each member of our team is committed to our mission: Saving lives by improving patient care.

NS: We are impressed by the company’s statement about who you are. Your goal is to save patients’ lives through CARE: Communication, Accuracy, Reliability, and Efficiency. Why is this so important to NeoGenomics and how does this translate to working with your pharma clients on their clinical trial work?

NeoG: We have over 120 pathologists and hematopathology PhDs at NeoGenomics and we are the largest cancer diagnostic-focused company in the United States, specializing in human hematologic and solid tumor malignancies. We have the medical expertise to diagnose disease and our overall purpose is to improve patient care. We are trying to solve the logistical challenge of making precise diagnoses, aiding in bringing new therapies to the market, and finding the unique hallmarks of a disease that point to the proper treatment. Focusing on the patient is what drives everything we do at NeoGenomics.

We’re flexible and supportive of our pharmaceutical clients to develop better, more effective treatments using biomarker testing to stratify patient populations and understand disease biology. Every day matters for cancer patients, so we must move fast to turn around test results quickly. We offer multi-modality technology platforms that offer the most appropriate and innovative approaches to biomarker discovery and validation. NeoGenomics is constantly offering new assays to the patient community to help diagnosis and guide treatment. It’s important to be able to help biopharma take a biomarker from early development through validation and ultimately commercialization, as it saves time and money and assures safety for the patient.

NS: NanoString’s nCounter platform plays a major role in the suite of specialty services offered at NeoGenomics. What made you choose to add nCounter expression assays to your suite of services and what are the biggest advantages of this workflow for you and your pharma clients?

NeoG: The nCounter platform provides a simple and cost-effective solution for multiplex analysis of RNA, DNA, or protein targets. NeoGenomics on-boarded the technology in 2017 and, at that time, first validated the PanCancer Immune Profiling Panel (770 targets) for our pharma clients to use in clinical research. NeoGenomics has found the nCounter an excellent technology for multiplexing many targets in a single reaction without amplification and through digital quantification. The platform is extremely flexible and reproducible and is a key technology to aid in translational research. NanoString offers multiple gene expression panels for oncology as well as immunology. Furthermore, NanoString offers custom options for clients who wish to add targets to existing panels or even create an entire Custom CodeSet from scratch for unique requirements.

NS: NeoGenomics is a strategic partner for the PanCancer IO 360™ Panel and you recently published a white paper on validation of the Tumor Inflammation Signature (TIS). Can you describe why this partnership is important for NeoGenomics and the types of clients who are interested in the IO 360 Panel and TIS?

NeoG: Our partnership with Nanostring and the execution of the PanCancer IO 360™ Panel supported by the validation activities, along with the direct provision of the Tumor Inflammation Signature, is extremely valuable to pharma clients both from a quality and turnaround time perspective as well as from the overall value of the gene signature.

The IO 360 Panel profiles the complex relationship between the tumor, microenvironment, and immune response in cancer. NeoGenomics has found that results from the IO 360 panel help our pharma partners significantly accelerate their research in immuno-oncology programs. The data helps to identify gene expression signatures of responder and non-responder populations, interrogate mechanisms of immune evasion, and characterize disease biology. The partnership with Nanostring has helped NeoGenomics accelerate our efforts to onboard this technology and ultimately provide a more educated and valuable service to our clients.

NS: Can you give our readers an example of how you integrate your full-service pharma offerings with NanoString technology?

NeoG: NanoString analysis is performed at our Houston facility, and the pharma services team regularly integrates other modalities into specimen processing. NeoGenomics offers one of the most robust, comprehensive, and clinically validated oncology diagnostic test menus in the world and can offer various approaches to best meet the requirements of a sponsor’s biomarker testing program and/or their patient population characterization needs. Multimodality assays are common as the pace of oncology research moves quickly. Histology, anatomical pathology, and other types of molecular assays such as NanoString are regularly part of our workflow.

NS: Can you tell us about your infrastructure and capabilities for supporting pharma clients throughout NanoString assay development and the companion diagnostics (CDx) lifecycle?

NeoG: Support for companion diagnostic development and commercialization is a major focus for NeoGenomics. Almost half of all targeted therapies and immunotherapies now have a biomarker-driven strategy which includes the potential for development of a CDx in later stages. We develop many new, early-phase assays for potential CDx use every year and these assets represent an important pipeline of new technologies that we hope to bring to our clinical reference laboratory following regulatory approval or widespread adoption by oncologists or hematologists.

Many of the early phase clinical studies that we support utilize RNA sequencing. This is an excellent approach for gathering extensive data regarding gene expression profiles and response to therapy. While it is an excellent research tool, RNA sequencing is not an optimized approach for CDx development, and in our experience complex gene signatures are exceedingly difficult to capture with an RT-PCR based approach like NGS. NanoString is an ideal solution and platform for developing gene signatures as a CDx-grade assay, with full commercial support and a defined pathway to regulatory approval and commercialization

NS: The IO 360 panel comes with an optional Data Analysis Service (DAS), which provides a report generated and delivered by a dedicated team of NanoString scientists. Do you see an increased interest by biostatisticians/analysts for robust data analysis tools that are easy-to-interpret and explain?

NeoG: Pharma and biotech clients understand the value of a comprehensive data analytics pipeline with graphical data outputs. It allows scientists to easily digest results, correlate markers as well as compare data across studies in a more confident way as results were analyzed using the same pipeline.

The tailored IO 360 data analysis report along with its comprehensive data output complements the tiered analysis solutions that NeoGenomics provides for pharma clients.

NS: The nCounter Breast Cancer 360™ panel with its DAS report is also a powerful tool that provides a holistic view of gene expression changes occurring within the microenvironment and immune response of breast cancer. How do you see this service facilitating hypothesis testing, data interpretation and publication?

NeoG: The Breast Cancer 360 panel with its DAS report allows researchers to study the potential interplay between the various immune response pathways (IDO1, PDL1, TIS) and how they may (or may not) correlate with risk of recurrence scores.

NS: NeoGenomics recently started offering the Prosigna® assay for measuring the risk of recurrence for early-stage ER+/HER2- breast cancer. Can you tell us how this assay fits in with your product portfolio and other nCounter-based assays?

NeoG: NeoGenomics leverages its leadership in precision diagnostics to deliver a complete suite of tests that meet clinical demands throughout the breast cancer journey. We are committed to providing all potential oncology biomarker diagnostic characterization markers for both diagnostic and prognostic assessments. The Prosigna assay fits in well with our overall breast cancer testing workflow and addresses a clinical need for specific breast cancer patient populations. It is appropriate soon after diagnosis to help assess the risk of distant recurrence in post-menopausal women with hormone receptor-positive, node-negative (Stage I or II), or node-positive (Stage II) breast cancer who will be treated with adjuvant endocrine therapy. The test results help stratify patients to low/intermediate risk of recurrence so that they may be spared chemotherapy or to high risk of recurrence so they can be considered for chemotherapy.

NS: One of your areas of expertise is laboratory services for oncology clinical trials, which are notoriously fast-paced with sudden changes bound to happen. How do you manage the necessary flexibility to serve these needs? How does a reliable and robust platform such as the nCounter support this aspect of your services?

NeoG: Instrument and assay reliability are hallmarks of service execution and a critical requirement for oncology clinical trials. The reliability and reproducibility of the NanoString technology and assays as well as the speed and ease-of-use of the technology support the fast-paced nature of clinical trials. In addition, the high quality and broad range of targets is critical to many potential needs of clinical research.

NS: What makes the partnership between NeoGenomics and NanoString a winning model for meeting the most pressing customer’s business needs?

NeoG: The team at NanoString is continuously innovating and impacting oncology research. NanoString’s suite of tools for translational research are addressing critical questions within translational research and clinical trials. NanoString assays, provided by NeoGenomics, within or CAP-accredited, CLIA-certified facility combines uncompromising quality, exceptional service, and innovative solutions for our pharma sponsors’ clinical research and directly impacts patient by improving their quality of care. This special partnership between the two companies ultimately helps to save the lives of cancer patients.

For Research Use Only. Not for use in Diagnostic Procedures.