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Reproductive Health Science Scales up Array Manufacturing to Support EmbryoCellect Test

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NEW YORK (GenomeWeb) – Reproductive Health Science, an Australian biotechnology company, recently quintupled its microarray manufacturing capabilities to provide for the roll out of EmbryoCellect, an array-based pre-implantation geneticscreening assay.

Michelle Fraser told GenomeWeb this week that Adelaide-based RHS recently acquired an Arrayjet Marathon instrument to produce EmbryoCellect, which competes with array-based PGS kits sold by Illumina, Agilent Technologies, Oxford Gene Technology, and others.

RHS had relied on a lower-capacity microarray production system called the Arrayjet Sprint for the past five years, but after introducing EmbryoCellect last year it has decided to upgrade to the Marathon, which has five times the capacity of the Sprint.

"Following the launch of EmbryoCellect, RHS is seeing an increasing market interest in the product and is therefore scaling up production," Fraser commented.

EmbryoSelect relies on array comparative genomic hybridization to compare the number of chromosomes in a sample cell to a known reference sample, providing a way to count the number of chromosomes in the test cell and detect whole chromosome aneuploidy. RHS' approach relies on a dual-component kit containing a single-cell amplification PCR kit and an in-house produced microarray. The company has also acknowledged plans to introduce a PGS kit for use on next-generation sequencing instruments in the future.

The debut of RHS' array test coincides with a flurry of activity in the PGS market. Recent months have seen the launch of CombiMatrix's CombiPGS service; OGT's CytoSure EmbryoScreen Array; and Agilent's GenetiSure Prescreen Kit.

The leader in PGS, though, is arguably 24sure, a microarray-based offering developed by Cambridge, UK-based BlueGnome, which Illumina acquired two years ago.

Next-generation sequencing is also emerging as a viable alternative to array-based PGS. In October Spanish company Bioarray rolled out an NGS-based PGS service. Good Start Genetics last month licensed the rights to commercialize an NGS-based PGS test from Johns Hopkins University. And Illumina last year launched VeriSeq, a sequencing-based PGS kit for use on its MiSeq system. Illumina has also hinted that it will eventually move most of its reproductive genetic health offerings to sequencing.

RHS introduced its array-based PGS assay in 2014, after it raised $3 million and began trading on the Australian Securities Exchange. Last month, the firm announced a distribution deal with Tani Medikal, which will offer EmbryoCellect to its clients in Turkey and other Eastern Mediterranean and Middle Eastern markets.

Fraser said that RHS is working on finalizing other distribution agreements shortly, and is pursing collaborations in Asia. Given this activity, RHS needed to scale up to the Arrayjet Marathon, which supports the printing of up to 100 microarray slides per run, using the Scottish firm's noncontact inkjet printing technology. The Marathon replaces the smaller Sprint system, which is capable of producing 20 array slides per run.

"RHS has developed its specific printing methodology and significant in-house capability in DNA microarray printing, which has led to the release of EmbryoCellect," said Fraser. She said the firm has been "very happy" with the Arrayjet technology finding it "far superior" to its previous experience with pin-printed arrays.

In addition to its need to scale up production, RHS also adopted the Arrayjet Marathon because the Arrayjet discontinued the Sprint system. And, according to Arrayjet CEO Iain McWilliam, the Marathon system is part of a general retooling of Roslin, UK-based Arrayjet's offerings.

McWilliam noted that one reason that Arrayjet decided to discontinue the Sprint was because it wanted to focus its efforts on accelerating the development of the Marathon range. The company's Marathon printers now come in two flavors: the Marathon Classic and the "higher specialized" Marathon Argus. It is the Marathon Angus that RHS chose for the production of EmbryoCellect, said McWilliam.

He noted that the system is "aimed firmly at the array diagnostics market where quality assurance and minimum downtime are priorities." The instrument relies on a suite of systems to monitor and record all performance parameters, McWilliam said, adding that it will notify users by email if the system requires attention.

Arrayjet will further upgrade the Argus later this year with its Iris optical quality control system. McWilliam said that Iris will add real-time imaging to the printing process.

Arrayjet's other 100-slide system, the Marathon Classic, has the same level of throughput as the Argus but the firm considers it to be its "entry-level instrument, a bare bones machine aimed at R&D and academic customers."

RHS' Fraser said that moving to the Marathon Argus should be a "smooth transition because all of the instruments in the Arrayjet range employ exactly the same 126-nozzle inkjet printhead." She noted that the company could still scale up further if needed. Arrayjet also provides the Ultra Marathon, which relies on the same printhead to produce 1,000 slides per run.

In addition to instrumentation, Arrayjet provides RHS with application science and engineering support. The company also maintains local engineering support in Australia.

According to McWilliam, RHS is not Arrayjet's only PGS client. He said that the company is working with a number of similar customers, though he declined to name them, citing non-disclosure agreements. He also said that there is some apprehension in the market about sequencing-based approaches, since so many labs have already invested in microarray technology.

"Ever since Illumina's acquisition of BlueGnome there have been industry rumors about whether or not the 24sure platform would be maintained or transferred to sequencing," said McWilliam. "There are many labs around the world committed to array-based PGS who don't want to let their expertise and equipment go to waste," he said. "RHS not only meets this need but they are advancing the field with their single-cell amplification technology."

Arrayjet's success in engaging PGS providers is just part of an overall favorable trend for the 15-year-old firm, which launched its first arrayer 10 years ago. "The array market is growing at an incredible rate," said McWilliam. "We now have customers in 23 countries and last year was our best on record, with sales up over 99 percent."

He attributed part of this growth to interest in the firm's printing services, which launched in 2011, as well as growth in its international presence. Arrayjet now has a North American office in Cambridge, Mass., which McWilliam credited with driving the firm's revenues.

Additionally, McWilliam said the new RHS Marathon Argus placement was just the first of several announcements that Arrayjet hopes to make in 2015.

"This will be an important year for Arrayjet," said McWilliam. "We will be launching new technology, publicizing new partnerships, and we expect to be making announcements on new distributors in Japan and Israel soon."

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