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Illumina Expects Array-based Reproductive Health Offerings to Eventually Migrate to Sequencing

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NEW YORK (GenomeWeb) — Although Illumina continues to see its array business as a significant revenue provider and highly complementary to its next-generation sequencing applications, it is the firm's clear intention to encourage users of its array-based reproductive health products to migrate over to NGS.

CEO Jay Flatley provided an update on the firm's efforts in the reproductive health market during a presentation at the Goldman Sachs Global Healthcare Conference, held last week in Rancho Palos Verdes, Calif. During his talk, which was webcast, analyst Isaac Ro asked Flatley about the firm's perspective on that market, specifically the opportunity in preimplantation genetic screening.

Preimplantation genetic screening is performed on embryos prior to implantation during an in vitro fertilization cycle. Conventional methods of testing include PCR and fluorescence in situ hybridization, but Cambridge, UK-based BlueGnome, which Illumina acquired in 2012, pioneered a genome-wide, microarray-based method called 24sure that it believes is more comprehensive.

While BlueGnome has helped many fertility clinics move to microarrays in recent years, Illumina has set its sights on converting those same clients over to sequencing in the future. In recent weeks it launched VeriSeq for screening all 24 chromosomes for the selection of euploid embryos. On its website, Illumina calls VeriSeq comparable to 24sure, and touts its "improved assay workflow, higher throughput, and enhanced performance."

At Goldman Sachs, Flatley estimated the addressable market size for both offerings to be about $600 million. And he underscored the company's plans to move 24sure customers to VeriSeq going forward.

"Over time we think the market will move more from arrays to sequencing because of the completeness and richness of the data set that you can get from sequencing today," said Flatley. "We offer both of the products into that market segment but over time we are planning to convert many of our existing customers over to a sequencing-based method."

At the same time, Illumina did recently launch a new array-based offering called Karyopmapping for preimplantation genetic diagnosis, demonstrating the company's binary approach to the market. Unlike PGS, which includes the screening of all 24 chromosomes, PGD is more focused, narrowing in on subchromosome imbalances in embryos of reciprocal translocation carriers, typically couples who have experienced recurrent miscarriages.

While it appears that reproductive health may be another market where sequencing is poised to become the dominant technology, Flatley did say last month that the Illumina is invested in the future of its array business and has no plans to exit the market, and he forecast future growth driven by sales to consumer genomics service providers and agricultural researchers and companies. He also said that plenty of Illumina's NGS customers continue to use arrays in their work.

"In the long run, arrays are always going to be the best technology if you know exactly what you are looking for and that doesn't change," Flatley said at the time. "They are easier, faster, and cheaper than sequencing."

At the conference last week, Goldman Sachs' Ro also asked Flatley about the global market for its reproductive health products in general.

Flatley commented that beyond the US, China is an attractive market for Illumina's PGD, PGS, and NGS-based noninvasive prenatal test. "There are 20 million babies born there every year, making it a huge market opportunity," he said. While Europe trails China in terms of opportunity and adoption, Flatley said that it was also an opportunity for the firm, given its "easier" regulatory environment.

On the regulatory front, Flatley said that it was Illumina's intention to take "any one of these products" through the US Food and Drug Administration review process. He noted that Illumina intends to submit its Verifi NIPT test to the agency for premarket approval by the end of this year, with approval expected some time in 2015.

Illumina last year submitted its Infinium Dx CytoSNP-12 BeadChip array for use in pediatric constitutional cytogenetics to the FDA for clearance but so far has not received the green light from the agency. Affymetrix, which submitted its CytoScan Dx Assay cytogenetics offering to the FDA at the same time as Illumina received clearance for the test earlier this year.

Illumina's presence in the array-based cytogenetics market could help it win clients for its other offerings in the future though. Last year, Illumina partnered with Kindstar Global to sell a research version of its CytoSNP-12 chip to Chinese customers. Kindstar provides a menu of molecular tests to members within a network of more than 3,300 hospitals across China.

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