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GenDx Acquires Quest's Sanger-based HLA Typing Product; Will Help Customers Convert to NGS

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NEW YORK (GenomeWeb) – GenDx has acquired Quest Diagnostics' subsidiary Celera's HLA typing business and will take over manufacturing and distribution of the Sanger sequencing-based product line, called AlleleSEQR. Abbott Molecular previously distributed the AlleleSEQR products, but will discontinue doing so at the end of the year.

In an interview with GenomeWeb, Wietse Mulder, managing director of GenDx, said that the firm's goal is to continue serving existing customers of AlleleSEQR and to eventually help them transition to next-generation sequencing-based products for HLA typing.

"GenDx will take over the [AlleleSEQR] product lines and manufacture them here in Europe and use our own distribution channels," Mulder said. The firm recently added new distributors covering Russia, Kazakhstan, Belarus, and Poland that will distribute the AlleleSEQR products, as well as GenDx's own Sanger-based products and NGS-based products.

GenDx, based in Utrecht, The Netherlands, did not disclose an acquisition price for AlleleSEQR.

Taking over the product line has required that GenDx scale up from its 30-person team in order to serve existing AlleleSEQR customers, which Mulder estimated constitute about 60 percent of the HLA typing market.

So far, GenDx has hired an additional 10 people over the last three months including sales representatives in the US and Europe, as well as production and support team members. He said the firm is also recruiting new distributors worldwide that specialize in HLA typing.

GenDx also manufactures and sells a competing Sanger-based HLA typing product line called SBTexcellerator. "We'll support both product lines independently and where possible, we will try to combine the best of both," Mulder said. In addition, it markets an NGS-based product line, NGSgo, for research-based HLA typing.

Despite the fact that AlleleSEQR is Sanger-based, Mulder said that the future of HLA typing is next-generation sequencing. Already, he said, the market is "transitioning much faster than we anticipated even a year ago," and anticipated that within two to three years the vast majority of HLA typing would be done by NGS.

Nonetheless, Mulder said the acquisition made sense because it will expand GenDx's customer base. The firm can then help those customers make a more seamless transition to NGS-based HLA typing. Mulder said that market demand will dictate how long GenDx will continue to manufacture and sell AlleleSEQR.

"Customers will still be able to get access to the product," he said. "And it's up to them, if they want to stick with AlleleSEQR or switch. If they want to switch, we have the technology and education to support them."

GenDx is also looking to bring its NGSgo kit through CE-IVD clearance. Last year, the firm received CE-IVD marking for the amplification portion of its kit and Mulder said it expects to have CE-IVD marking for the entire kit— including amplification, NGS library construction, and barcoding — by the end of the year, after which it will be able to sell the kit as a diagnostic product.

GenDx's kits will be able to run on the Illumina MiSeq, Thermo Fisher Ion Torrent PGM, or Pacific Biosciences RS platform. Customers would still need to buy the platform manufacturers' specific reagents and chips.

Mulder said that GenDx's biggest competitors for HLA typing products are sometimes the sequencing manufacturers themselves. For instance, Illumina markets its own HLA sequencing panel for the MiSeq and has said that many of its MiSeq orders are from customers doing HLA typing, including HistoGenetics, which runs more than 30 such instruments.

Other competitors are Omixon, which is developing an NGS-based kit for HLA typing that is based off the workflow of a clinical service offered by Children's Hospital of Philadelphia; and Immucor, which offers HLA typing based on sequence-specific oligonucleotides and other established technologies, and is also collaborating with Stanford University spinout Sirona Genomics to develop an NGS-based workflow.

Aside from HLA typing, Mulder said that GenDx also offers products for chimerism monitoring in stem cell transplantation patients. Those products are based on real-time PCR and were developed by its subsidiary, KimerDx. Mulder said the real-time PCR chimerism products it will have access to with the AlleleSEQR acquisition will be complementary to its current offerings. Longer term, Mulder said the firm would likely migrate its chimerism monitoring products to next-gen sequencing as well.

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