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Beckman Coulter Receives CLIA Certification with Eye Toward NGS and Sanger-Based Tests

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This story was originally published May 14.

Beckman Coulter Genomics has received CLIA certification for its sequencing services facility as it looks to develop assays for both Sanger and next-gen sequencing platforms.

The company announced the CLIA certification last week alongside the launch of a Sanger sequencing-based BRAF test — the first of other molecular diagnostic tests to come, according to Joseph Repp, vice president and general manager of Beckman Coulter Genomics.

Repp told Clinical Sequencing News that the company will develop assays in the areas of oncology and infectious disease, and that it will primarily serve two different types of customers — the pharmaceutical and biotech industry, as well as individual physicians.

Those two types of customers will have different needs in terms of the types of assays that are developed, and whether they are next-gen or Sanger-based, he said.

While the pharma customers will likely "value more the [CLIA] registration," physicians will "be much more specific about which assay they want run under that registration," Repp said.

Currently, pharmaceutical companies have been enlisting Beckman Coulter's services primarily for phase 3 clinical trials, Repp said, noting that pharma tends to do initial sequencing early on for research purposes and then takes a more targeted sequencing approach during phase 3 to validate the initial research findings. It is in this later phase that these companies are looking for sequencing within a CLIA lab, he said.

Beckman Coulter is currently equipped with multiple Sanger and next-gen sequencing platforms, including Illumina HiSeq, Roche 454 GS FLX, and Life Technologies SOLiD.

Repp said the company plans on acquiring other platforms that are not yet on the market, such as the HiSeq 2500 and Life Tech's Ion Proton, as well as other undisclosed instruments. He expects the HiSeq 2500 and Ion Proton instruments to be running in the company's services lab by the end of the year.

The company does not currently have plans to purchase a benchtop platform like the MiSeq or PGM primarily because the company requires higher throughput than those instruments deliver, Repp said.

"We have not seen the market ask us to make investments in those areas," he said. For the "volumes that are going through our lab, having the HiSeq is a much more appropriate platform."

Beckman Coulter's first test is a Sanger sequencing-based BRAF assay that screens for mutations in exon 11 and exon 15. Repp said that the company started with BRAF because the gene has mutations associated with several different cancers, many of which have been "suggested to be drivers of cancer progression."

Repp said that the test is not necessarily for a specific disease indication, or to point the way to a specific therapeutic agent. Rather, Beckman Coulter Genomics expects that physicians will use the assay as one part of making "diagnostic choices" for their patients.

Repp would not elaborate on future tests, but said that the company is planning to develop additional Sanger-based tests as well as next-gen sequencing-based tests.

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