JP Morgan Healthcare Conference, Day One: Genomic Health, Meridian Bioscience, Qiagen

SAN FRANCISCO (GenomeWeb) – The 35th Annual JP Morgan Healthcare Conference began here Monday with several life science research tools and diagnostic firms making presentations to investors and other attendees.

The following are capsules from the presentations and breakout sessions of Genomic Health, Meridian Bioscience, and Qiagen. Coverage of Illumina's presentation is available here.

Genomic Health

Genomic Health CEO Kimberly Popovits talked about the firm's goals for 2017: deliver double-digit revenue growth, post a full-year profit, continue growing its invasive breast cancer testing business, increase reimbursement for its prostate cancer test, expand its product pipeline, and launch its AR-V7 assay.

The AR-V7 assay is the result of a marketing agreement with Epic Sciences inked last July. The test is intended to help guide treatment selection in metastatic prostate cancer patients, and represents a 50,000-patient market opportunity, according to Popovits.

"It's a great fit for the company, [and] we think a great story for payors," she said, noting that a study published in JAMA Oncology last year showed that patients with AR-V7-positive circulating tumor cells have significantly better outcomes when treated with taxane therapy.

She said Genomic Health won't initially add sales reps specifically for the new assay, instead leveraging its oncology and urology sales forces.

The alliance with Epic followed last year’s launch of Genomic Health's Oncotype SEQ, the firm’s first liquid biopsy product, which targets 17 genes with genomic alterations associated with malignant transformation and response or resistance to therapy. The test is intended to inform the treatment strategies for stage IV solid tumors across a number of cancers including lung, breast, and colon, among others.

Meridian Bioscience

Jack Kraeutler, chairman and CEO of Meridian Diagnostics, discussed how his firm's acquisition of Magellan Bio last March had given it an entry into the point-of-care diagnostics field and bolstered its revenue growth. Magellan’s primary product is a lead-poisoning test for children and adults.

The firm is developing a new version that will test for lead plus another marker for oxygen-carrying capability. Though the Magellan business has several tests in the pipeline, Kraeutler declined to discuss its plans in detail. He did say, however, that there is interest around the world for testing for other heavy metals.

But one of the synergies of the acquisition was Magellan's access to 7,000 pediatricians, which has provided a cross selling opportunity for Meridian’s Illumigene molecular diagnostic portfolio.

Meridian currently markets 10 MDx tests for infectious agents or diseases such as C. difficile, Strep A and B, HSV 1 & 2, CT/NG, and malaria while its pipeline includes assays for babesia, CMV, Helicobacter pylori, Kingella, Zika virus, and Lyme disease.

Meridian anticipates exceeding $200 million in annual sales this year, with MDx products accounting for around $43 million, Magellan contributing $21 million, life science reagents bringing in $53 million, and its older tests generating around $96 million.

Kraeutler also noted that China has been a fast-growing market for the firm. It opened an office there in 2015 and hired three staffers. Since then, sales there have gone from $2.5 million in 2015 and are expected to be $5.8 million or more in 2017.

Qiagen

Qiagen had already announced its big news for the day, the acquisition of bioinformatics company OmicSoft, in advance of its presentation. OmicSoft markets a suite of tools that allow researchers to analyze and visualize data and compare them to large, publicly available multi-omics data sets, and Qiagen said the acquisition will provide it with scalable and flexible software architecture solutions that will enable it to expand its bioinformatics offerings.

But it also announced that it had submitted its QuantiFeron TB Gold Plus assay, a fourth-generation of its Quantiferon tuberculosis test, to the US Food and Drug Administration, and unveiled enhancements to its GeneReader NGS system.

Qiagen CEO Peer Schatz told attendees of the firm's presentation that QuantiFeron Gold, the third-generation assay, brought in sales of $145 million in 2016. Among its goals for the test are 25 percent sales growth at constant exchange rates in 2017, and $300 million in sales of the test in 2020.

He further noted that in 2016 30 percent of the market in the US had converted to QuantiFeron, an interferon gamma release assay (IGRA) that uses immunoassay technology to detect the release of interferon-gamma as a proxy for latent tuberculosis infection, from the standard tuberculin skin test. That is up from 15 percent in 2013.

Regarding the GeneReader, Schatz said that the company aims to launch at least five new QIAact gene panels during the year. It also intends to soon offer services to customers to develop customized gene panels for use on the GeneReader system, providing unlimited assay design, Schatz said.

Among the other enhancements noted by Schatz was new chemistry that doubles the output per flow cell for the GeneReader, 20 percent higher sample throughput, and higher batch efficiency.

He said the company met its goal for a 10 percent share of the global annual market for new placements of benchtop sequencers used for oncology applications.

Schatz also noted during his presentation that Qiagen has placed more than 1,750 of its QIAsymphony automated diagnostic platforms to date, and it expects that number to rise to 2,000 by 2020. In the near-term, the company anticipates FDA clearance of its cytomegalovirus test on the QIAsymphony this year.

Schatz said Qiagen has guided for 2017 sales growth of 6 to 7 percent at CER with earnings per share of $1.25 to $1.27 at CER.

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