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Illumina, Siemens Forge Deal to Make HIV Test Compatible with MiSeq

NEW YORK (GenomeWeb News) – Illumina and Siemens Healthcare Diagnostics have entered a partnership to make Siemens' molecular HIV tests compatible with the MiSeq platform and to set new standards for the use of next-generation sequencing for the identification of infectious diseases and potential treatments paths.

Under the partnership announced today, the companies plan to make Siemens' Trugene HIV-1 molecular tests compatible with Illumina's MiSeq benchtop sequencing system, "with the ultimate goal of introducing breakthrough sequencing-based infectious disease assays for the clinical diagnostics market," they said in a joint statement.

The Trugene HIV-1 Genotyping Assay was launched a decade ago and was the first DNA sequencing-based HIV test to be approved by the US Food and Drug Administration. Making it compatible with Illumina's system would position Siemens "to help even more clinical laboratories leverage next-generation sequencing for their infectious disease testing with the fastest turnaround time and highest accuracy possible," the companies said.

The deal also falls in line with Illumina's emerging push toward the clinical market. During its recent third-quarter earnings release, the firm announced a restructuring effort that includes creating a new business unit focused on the clinical market, though it provided no further details at the time.

"Partnerships with global leaders like Siemens are a key element of our strategy to drive widespread adoption of MiSeq in the clinical setting," Illumina President and CEO Jay Flatley said today. "Siemens has a long track record of success in developing regulated products for infectious disease testing and we are excited to join them in taking next-generation sequencing to this important market."

The clinical space represents a major opportunity for next-generation sequencing, with the US market alone a $3.6 billion opportunity, Jon Groberg an analyst at Macquarie Equities Research, said in a report in July.

He noted, though, that while infectious disease could be a large market opportunity, it is an "unlikely" near-term opportunity for next-generation sequencing because of the low price point for many tests that already exist for detecting infectious disease.

Regardless, the partnership between Illumina and Siemens further adds to an already dynamic landscape in the benchtop sequencing space. Though both the MiSeq and Life Technologies' Ion Torrent Personal Genome Machine were launched only within the past year, they have attracted interest from both the investor and research communities because of their potential to extend next-generation sequencing technology to new markets, including the clinical space.

As GenomeWeb Daily News' sister publication Clinical Sequencing News reported last week, CLIA-certified laboratories at the Children's Hospital of Los Angeles and the University of Pennsylvania are developing diagnostic tests for retinoblastoma on the Ion Torrent platform.

Illumina's HiSeq next-gen sequencing platform provides the base for prenatal tests being developed by Sequenom and Verinata Health.