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JP Morgan Healthcare Conference, Day Four: Luminex, BioNano Genomics

San Francisco

SAN FRANCISCO (GenomeWeb News) – The 33rd Annual JP Morgan Healthcare Conference concluded here Thursday with presentations from several life science tools and diagnostic firms, including Luminex and BioNano Genomics.

The following are capsules from the above companies. Coverage of previous sessions is available here.


Speaking at the JP Morgan Healthcare Conference on Thursday, Luminex CEO Nachum Shamir told attendees of his presentation that the firm's future revenue growth hinges on its molecular diagnostics business. Though its partnership channel provided the firm with roughly $118 million in revenues for 2014, its compound annual growth rate for that channel is around 6 percent. Conversely, the company's molecular diagnostics business brought in around $85 million in 2014 but had a CAGR of 27 percent from 2010 to 2014.

Key to Luminex's growth in the molecular diagnostics market is its next-generation MDx system, Aries. The system is a fully automated sample-to-answer system that combines real-time PCR chemistry that Luminex acquired in 2012 along with EraGen Biosciences with the sample-to-answer molecular testing instrument it acquired along with startup GenturaDx that same year. The company has been positioning the platform as a higher-throughput, target-specific option for small- to mid-sized labs.

In October the firm pushed back the commercialization timeline of Aries, which previously was targeted for a European launch later this year and a US launch in early 2015. Shamir today reiterated comments he made in October during the company's third-quarter conference call that Aries will now undergo clinical trials in the first half of this year, likely beginning in March.

Luminex intends to submit a 510(k) application to the US Food and Drug Administration and launch the system for research use only this coming summer. Shamir said the firm hopes to receive FDA clearance in the fourth quarter while launching the system outside the US by the end of the year.

Luminex also intends to submit marketing applications for around five assays to run on the system and is targeting mid-2016 clearance of those. Luminex previously said that it planned to commercially launch assays for the platform for Clostridium difficile, herpes simplex virus I and II, a combined influenza A/influenza B/respiratory syncytial virus, norovirus, and group B Streptococcus.

Shamir said that Luminex anticipates reporting FY 2014 revenues within its guidance range of $225 million to $228 million, and added that he expects the firm to grow much more rapidly after the Aries launch, as it expects to reach a broader customer base.

Asked about the effect next-generation sequencing-based diagnostics could have on Luminex, Shamir said that he doesn't believe it offers a threat to the company's portfolio of infectious disease assays, but said there could be some effect on its cystic fibrosis assay, where a more rapid answer isn't necessary.

He also said during a Q&A session that he doesn't expect NGS to have much of an impact on the transplant rejection testing market and tissue typing because it doesn't provide an answer quickly enough. CFO Harriss Currie added, "The cost per sample currently doesn't match up" for NGS in that market.

BioNano Genomics

BioNano Genomics CEO Erik Holmlin told investors that the company will start preparing an entry into the clinical space with diagnostic assays for use on the Irys system during 2015.

Irys is a long-read genome mapping technology that provides information about the location, order, and orientation of functionally relevant components of the genome, including the size and location of long repeats and integration sites. The system was commercialized in 2013.

Currently, Irys is for research use only, but by the end of the year, the firm plans to establish a diagnostic roadmap by completing readiness for a cytogenetics assay, Holmlin said, adding that longer term, assays may also be developed for pediatric genetic disorders and oncology.

Also, BioNano aims to finalize the development of version 3 of the Irys chip, which would be able to map 10 genomes per day, compared to one genome per day currently. The company has a revenue target of between $12 million to $13 million for 2015, a sharp increase from $5 million that it brought in in 2014. It also hopes to grow Irys' installed base to between 50 and 65 instruments from 23 at the end of 2014, Holmlin said.

In November, BioNano completed a Series C financing round that raised $53 million. The total addressable market for the platform is currently $2 billion, with another $2.1 billion for the system's consumables, Holmlin said.