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18 Clinical OMICs July/August 2017 www.clinicalomics.com Diagnostics Illumina Wins FDA Approval for NGS-Based Colorectal Cancer CDx Illumina's Extended RAS Panel, a next-gen- eration sequencing (NGS) kit for use with the company's MiSeqDx System to help clinicians identify patients eligible for treatment of metastatic colorectal can- cer (mCRC) with Amgen's marketed drug Vectibix (panitumumab) has won approv- al from the FDA. Vectibix was approved by the FDA in 2013 as the first monoclonal anti-epider- mal growth factor receptor (EGFR) anti- body indicated for use in combination with FOLFOX for first-line treatment for patients with wild-type RAS mCRC. "Together with Amgen, we've devel- oped a companion diagnostic test kit that interrogates 56 variants across the KRAS and NRAS genes in order to estab- lish mutant status in a single test," Garret Hampton, Ph.D., EVP of clinical genomics at Illumina, said in a statement. "The Ex- tended RAS Panel on the MiSeqDx System enables labs to implement an in-house solution for precision oncology and signi- fies that NGS has reached a milestone as a clinical diagnostic platform to aid thera- peutic decision-making in oncology." Through the Extended RAS Panel, clini- cians will be able to identify patients who may benefit from treatment with Vectibix. The panel allows simultaneous detection of 56 RAS mutations contraindicated for anti-EGFR therapy. Genoptix plans to develop clinical diagnostics for selected hematologic oncology indications in the U.S. using Bionano Genomics' Saphyr. The alliance is intended to com- bine Genoptix's oncology diagnostics and informatics services with Saphyr, Bionano's high-speed, high-through- put genome–mapping solution. Development efforts will focus on indications where detection of large structural variations of the genome is required for accurate diagnosis. "What I would say is that there are indications in the standard hema- tology workflow where the existing methods can be drastically improved with a digital solution like Bionano's," Bionano President and CEO Erik Holmlin, Ph.D., said. Bionano aims to have its technol- ogy adopted by Genoptix this year. The timing of a commercial launch, Dr. Holmlin said, will depend on how quickly the companies address chal- lenges ranging from technology to reimbursement. Saphyr is the company's third-gen- eration optical mapping solution, designed to enable visualization of whole genomes with long- range reads from 100,000 bp to mega- base pair lengths. Saphyr is one of Bionano's two sys- tems for next-generation mapping; the other is called Irys. "Irys can generate data that are of comparable quality to Saphyr, but Irys would not be able to accommodate the kind of commercial lab testing volumes that Saphyr can," Dr. Holm- lin said. "What makes Saphyr unique is its incredible increase in through- put and speed—roughly 10 times the throughput and one-tenth the time on Saphyr compared to Irys." According to Bionano, Saphyr offers much higher resolution than available through karyotyping or fluorescence in situ hybridization (FISH)—and assembly and discovery algorithms that offer greater sensitivity than s e q u e n c i n g - b a s e d t e c h n o l o g i e s . Saphyr also offers 99% sensitivity for large homozygous insertions/dele- tions, 98% sensitivity for transloca- tions, and 87% sensitivity for large heterozygous insertions/deletions. Genoptix provides a comprehensive testing solutions in hematology and solid tumor molecular profiling, and is among the largest hematopathol- ogy centers in the U.S. The company focuses on diagnosing cancers and disorders in bone marrow, blood, and lymph nodes, and solid tumor work- ups using molecular testing. Novartis acquired Genoptix in 2011 for $470 million, and sold the commer- cial lab segment in March to a manage- ment group led by Joseph M. Limber, in partnership with Ampersand Capi- tal Partners and 1315 Capital. Novartis retained Genoptix's BioPharma busi- ness as Navigate BioPharma Services, which provides specialized services in oncology trials.—Alex Philippidis Genoptix to Develop Blood Cancer Dx Genoptix Raycat / Getty Images