March 1, 2015 (Vol. 35, No. 5)

Established CRO Embraces Genomics to Advance Pathology and Oncology Biomarkers

Integrated research services that combine genomics and traditional methodologies are the focus of ILS—or Integrated Laboratory Systems—a full-service CRO in Research Triangle Park, NC.

“We can develop and validate novel single nucleotide polymorphism (SNP) assays and the biological data that supports the use of that SNP. That combination sets us apart,” says Leslie Recio, Ph.D., DABT, chief scientist at ILS. These SNP capabilities are being honed in a project supported by the National Cancer Institute. The goal of the project is to develop and validate an SNP assay and to assess the impact of this SNP on the efficacy of a cancer chemotherapeutic agent.

“We understood the toxicology,” asserts Dr. Recio. “We knew the types of biological data that were needed to support this SNP before it could move to clinical trials.” And so ILS was well positioned to win the grant.

ILS integrates data from cell culture models and genomic technologies to more efficiently identify potential hazards and individuals at risk than traditional methods using animal models.

Traditional Approaches, Plus Genomics

ILS offers a mixed portfolio of regulatory toxicology testing and investigative studies combining traditional cell culture and animal models with genomic endpoints. Additional capabilities include on-site access to board-certified pathologists and a full complement of tissue processing, histology, and genomics expertise. This combination of strengths, says Dave Allen, Ph.D., vice president of science and strategy, is “somewhat unique.”

“Some of our competitors in the genomics industry come to us for our pathology capabilities to provide a phenotypic anchor to specific genomic alterations, performing, for example, genomic profiling on tumors isolated from formalin-fixed, paraffin-embedded (FFPE) tissues to identify specific mutations or alterations in gene expression associated with the lesions of interest,” explains Dr. Allen.

ILS core services include regulatory toxicology testing, investigative in vivo and in vitro toxicology, histopathology, genetic toxicology, toxicogenomics, bioinformatics, and computational toxicology. ILS also offers information sciences services, including document preparation, database development, and scientific writing, according to its website.

Growth and Acquisitions

Since its founding some 30 years ago, ILS has grown from a government contractor focused primarily on in vivo toxicology and environmental science to a full-service provider of preclinical research and testing services. It currently serves government, commercial, and academic clients.

Nearly three years ago, ILS added a genomics division by acquiring Beckman Coulter Genomics (now ILS Genomics). That acquisition significantly expanded its toxicology capabilities, adding genotyping, sequencing, gene expression, biologics evaluation and safety testing, and diagnostic kit validation.

With several multinational customers that must adhere to a variety of regulatory requirements, ILS follows U.S. and international guidance to ensure its services are acceptable to all applicable regulatory authorities. ILS is also a CLIA-licensed facility. According to Dr. Recio, ILS can “conduct genomic endpoints for clinical trials and other regulated studies for pharmaceutical, chemical, and agricultural clients throughout the world,” while adhering to international requirements.

Emerging Opportunities

Many senior scientists at ILS are involved in developing health effects test guidelines under the Organization for Economic Co-operation and Development (OECD). Participating in OECD and other international efforts “has opened opportunities in terms of new areas of focus, new projects, and access to new technology,” Dr. Allen remarks.

High-throughput screening and computational toxicology are two examples. Dr. Allen notes an ongoing trend that combines computational approaches with high-throughput human cell-based assays to screen and prioritize chemicals for further evaluation.

“Historically, many regulatory test methods have been based on laboratory animal tests,” continues Dr. Allen. “However, new legislation, the need to test thousands of chemicals, and a shift toward collecting more mechanistic information that is more relevant to human health effects” are encouraging the use of nonanimal approaches in regulatory safety testing.

While many of these tools remain in development, some have the potential to challenge traditional gold-standard methodologies that are based on low-throughput in vivo model systems. As an example, Dr. Recio mentions ILS work—conducted under an SBIR grant—to develop human stem cell-based assays to assess the potential impact of environmental agents on the epigenome that regulates differentiation.

That, along with other SBIR grants, helps ensure that ILS researchers work at the forefront of science, Dr. Recio says. “Four SBIR projects are underway currently. Two focus on using genomics tools to develop better predictive models for human medicine and toxicology. These funds allow us to be more innovative and to develop new commercially viable offerings for our customers.”

ILS’s Research Triangle Park location helps, too. “The National Institute of Environmental Health Sciences and the National Toxicology Program (NTP) are headquartered here, along with the Environmental Protection Agency’s Office of Research and Development,” Dr. Allen adds. Scientists from throughout the world visit these institutes and contribute to the cross-fertilization of ideas in the local research community.

Transparency and Access

The ILS website touts a “truly personalized partnership,” which Dr. Allen says really means transparency and access. “Our scientists talk directly with our customers.” The objective, he says, is to encourage and enable innovative thinking.

When it comes to big data analysis, ILS stresses transparency. “We apply open source tools where possible,” Dr. Allen says. “Our clients want to understand how we arrived at a particular result, so we can’t simply apply a black box tool with a broad scope of hidden algorithms.”

Next: Next-Gen Sequencing

As ILS continues to expand its capabilities, it is examining next-generation sequencing platforms with an eye to both innovative and traditional, validated approaches.

ILS also plans to expand its computational toxicology and bioinformatics capabilities. “Today, our scientists are working with the National Toxicology Program and the Environmental Protection Agency to identify ways to use high-throughput assays for screening and to prioritize the broad universe of chemicals,” Dr. Allen says. “The demand for this specialized expertise continues to grow.” 


Location: 630 Davis Drive, Suite 160, Morrisville, NC 27560

Phone: (919) 281-1110


Principal: T.K. Rao, Ph.D., President

Number of Employees: 100

Focus: ILS is a contract research organization with expertise in toxicology; molecular and genetic examinations; mechanistic studies of cell growth; cancer and cancer chemoprevention; translational research; environmental evaluations; and scientific information services.

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