FISHing for new services

SANTA CLARA, Calif.—Madison, Wis.-based cell-line quality assurance service provider Cell Line Genetics Inc. (CLG) announced in February a collaboration with California-based life-science and chemical analysis company Agilent Technologies Inc. that will allow for the creation of state-of-the-art stem cell line characterization services for regenerative medicine and other research areas.

CLG aims to develop best-in-class, high-throughput genomic characterization workflows to monitor the integrity of cell lines using custom microarrays and proprietary fluorescence in-situ hybridization (FISH) assays from Agilent. The workflows will be used to characterize stem cell-line purity and genomic integrity in translational and regenerative medicine and cancer research.

CLG evaluated several platforms before selecting Agilent’s genome-wide CGH+SNP microarrays. CLG chose Agilent’s technology because of its capacity for detecting amplifications, deletions and cell-line clonality with high sensitivity in a high-throughput environment.

“Cell Line Genetics is a new customer for Agilent that wanted to internalize chromosomal microarray testing for stem cell line characterization,” says Victor Fung, senior director of global marketing for Agilent Technologies’ Genomics Solutions Division. Financial terms of the agreement were not disclosed.

The collaboration will allow CLG to offer array CGH (aCGH) services for cancer cell line characterization, enabling it to detect anomalies in greater numbers with higher sensitivity than traditional cytogenetics. In addition, aCGH allows CLG to offer its customers faster turnaround time.

CLG will be able to use Agilent’s comprehensive menu of FISH assays, including a highly specific and sensitive product line for oligonucleotide fluorescent in-situ hybridization dubbed SureFISH, to confirm a wide range of chromosomal aberrations identified down to the single-cell level, providing a robust apparatus for characterizing genome integrity and purity.

“Collaborating with Agilent on custom microarray and SureFISH probe solutions gives us the most flexibility to innovate and expand our services,” said Cell Line Genetics CEO and President Rob Herrera in a media release announcing the partnership. “It allows us to easily design proprietary arrays and assays to support our customer’s research and translational needs.”

“We use our OLS-synthesis technology to design oligo-based FISH probes with base-pair level resolution,” Fung tells DDNews. “This gives our probes superior specificity to BAC-based probes. Whereas repetitive and GC-rich regions cause problems for BAC-based probes, we can design probes specifically to interrogate these challenging regions.”

After testing more than 15,000 stem cell lines, CLG found that 20 percent showed aneuploidy, and 60 to 70 percent of those were mosaic. Mosaicism occurs in almost all cancer cells, and the cells harboring genomic anomalies such as these can have a proliferative advantage and may overtake a culture, resulting in the loss of samples, wasted resources and compromised study data. These findings emphasize the need for robust cell-line characterization and genomic integrity testing tools.

“Genomic instability and clonal evolution is a reality in human stem cell lines,” says Fung. “While some academic core labs offer cell line testing services, Cell Line Genetics is the only company that offers commercial-grade, stem cell line quality assurance testing. Assuring the purity and integrity of stem cell lines for clinical research in humans helps researchers address this biomolecular instability problem and is critical to the future success of regenerative medicine.”

CLG is a quality assurance services provider with products in the regenerative medicine market. The company focuses on adult and pluripotent stem cell lines in research, preclinical and clinical studies. Their clients include research institutes, universities, biotechnology and pharmaceutical companies.

Agilent is a global California-based company and a technology leader in chemical analysis, life sciences, diagnostics, electronics and communications. The company posted revenues in FY2013 of $6.8 billion and employs 20,600 people. Agilent has customers in more than 100 countries.