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JP Morgan Healthcare Day Three: Foundation Med; Cepheid; BD; Invitae; GenMark; Berry Genomics

SAN FRANCISCO (GenomeWeb) – The 34th Annual JP Morgan Healthcare Conference entered its third day here Wednesday 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 Foundation Medicine, Cepheid, Becton Dickinson, Invitae, GenMark Diagnostics, and Berry Genomics.

Foundation Medicine

Foundation Medicine's CEO Michael Pellini discussed additional details around its liquid biopsy assay, which it will launch by the end of the quarter, as well as the firm's plans to develop a universal companion diagnostic. In addition, he said that the company plans to submit its first pre-market approval application to the US Food and Drug Administration this year.

The company's liquid biopsy assay, FoundationAct, will genomically profile circulating tumor DNA from patients for whom a tissue biopsy cannot be obtained. Pellini stressed that the assay was designed to help guide oncologists' treatment decisions. But the company is also developing an assay that could be used to monitor patients' disease burden and response to treatment.

Pellini added that the company is taking a "new approach to companion diagnostics" in work it is doing to develop a universal companion diagnostic that will be a regulated product used with any targeted agent or immunotherapy.

The company is also on track to submit its first pre-market approval application to the US Food and Drug Administration this year in conjunction with work it has been doing with the pharmaceutical firm Clovis.

Also in 2016, Pellini said he expects the company will expand outside of the US, an effort that is being driven by Roche.

Earlier this week, Foundation pre-reported that it expects its fourth quarter and full year 2015 revenues to be up 39 percent and 53 percent, respectively.


Following the firm's announcement earlier this week that its fourth quarter revenues were in line with previous guidance, Cepheid CEO John Bishop commented on the late flu season and highlighted upcoming product launches.

He reiterated that the lower-than-expected flu revenues were offset by stronger-than-expected sales for commercial systems and its High Burden Developing Countries program. However, he also noted that the firm’s flu test sales in the fourth quarter were roughly equal to the comparable period of 2014, the result of the company taking more market share, Bishop said.

Meanwhile, he laid out the firm’s expectations for product introductions over the next few years. In the US this year, Cepheid expects to begin selling a next-generation test for methicillin-resistant Staphylococcus aureus that will include new strains; new tests for carbapenemase-producing organisms, Group A strep, and trichomonas (male claim); and a flu/respiratory syncytial virus test for the recently unveiled GeneXpert Omni point-of-care molecular diagnostic system. In addition, Cepheid has plans to launch several tests for the Omni internationally, including assays for multidrug-resistant tuberculosis, Ebola, HIV qualitative and viral load, and hepatitis C viral load in 2016. In following years, Cepheid intends to add HPV and CT/NG, with the full Xpert menu on Omni in 2018.

The Omni, which Cepheid first unveiled at the American Association for Clinical Chemistry annual meeting in July, is expected to launch in emerging markets in mid-2016 and in the US by the end of this year, said Bishop. He reiterated the firm’s plan to also launch its MTB/RIF Ultra assay on the Omni in 2016 in these resource-poor emerging markets. This new test will be able to process a single sputum specimen with over 90 percent sensitivity, he noted.

According to Bishop, the Omni’s potential customer base exceeds 100,000 in the US and internationally each.

Bishop also said during his presentation that among molecular diagnostic players, Cepheid grew the fastest during the first nine months of 2015, with revenues rising 18 percent. The next nearest competitor was Roche at 10 percent, he noted. Bishop expects Cepheid to soon be the second largest molecular diagnostics firm by sales in the world, trailing Roche and surpassing well-established competitors such as Qiagen and Abbott. He also said the firm still believes it will break through to profitability in 2017.

Separately Wednesday, Cepheid said it had inked a collaboration with MedImmune and the European COMBACTE consortium to develop rapid molecular tests for Staphylococcus aureus and Pseudomonas aeruginosa for use in clinical trials of a monoclonal antibody-based therapeutic for ventilator-associated pneumonia. 

Becton Dickinson

Vincent Forlenza, chairman, president, and CEO of Becton Dickinson, noted his firm’s growing presence in the genomics research market. Over the past two years, BD acquired Cellular Research, which has developed tools for massively parallel single-cell genetic analysis based on its proprietary molecular indexing technology, and Irish firm GenCell Biosystems, which has developed a proprietary microdroplet reaction technology called Composite Liquid Cell.

Just a few months ago, BD launched its first major products designed specifically for genomics research, unveiling the BD FACSseq cell sorter and BD Precise Assays for high-throughput single-cell gene-expression analysis studies at the American Society of Human Genetics annual meeting. Forlenza said these launches will be followed soon by a new library prep solution developed by GenCell.

While these offerings will help BD make inroads in the genomics research market, the firm is already established in the molecular diagnostics market with its BD Max system. The firm has focused its efforts for that platform on infectious disease and women’s health assays, and Forlenza said that BD expects to launch new assays for chlamydia and vaginitis on the BD Max this year.


Invitae CEO Randy Scott discussed the company's growth plans for 2016 and into 2017, which will build upon expansions the company made to its platform last year with new additions "across all the major disease areas" for symptomatic adults and children, as well as a new launch into testing of healthy adults.

During his JP Morgan presentation, which was webcast, Scott said Invitae specifically plans during 2016 to increase the genes it tests to 3,000, starting in the first half of the year with additions primarily in the pediatric genetics space, and then following that in the second half of the year with the remaining "long tail" of genes known to be implicated in inherited genetic diseases and drug responsiveness.

During 2016, the company will also begin pilot work to support an expansion in 2017 into the adult health and wellness market, Scott said.

To this end, Invitae will first launch an initial pilot panel culled from genes it has already launched as part of its test offerings for symptomatic adults. Scott said this offering will be developed in a very "medically responsible way," focused on genetic information the company believes is definitively actionable. Then, by the second half of 2016, with Invitae's overall content expansion, pharmacogenomics and carrier testing genes will also be added.

As the company moves into 2017, Scott said the plan is for this full health and wellness panel to be offered through the company's patient-pay market. Invitae has a tiered pricing structure in which out-of-network and non-contracted institutions pay $1,500, in-network third-party payors and institutions that contract with Invitae pay as low as $950, and patients who do not meet insurance criteria for coverage pay $475 directly to the company. In all cases the price is the same regardless of the indication for testing or genes analyzed.

Patients seeking the company's new health and wellness testing would pay out of pocket at the patient-pay tier, Scott said during his talk. But the eventual hope is that by building a customer base and collecting data, Invitae will eventually be able to make a case to payors to cover genetic testing of otherwise healthy people.

With this new health and wellness panel, Invitae also plans to start a participatory research program in which patients can opt to share their results for research studies, and otherwise compare and connect with other individuals in the company's network.

According to Scott, Invitae's attention in 2016 will also be focused sharply on gaining reimbursement from more and larger payors for the genetic testing of symptomatic adults and children. Two significant publications during the previous year that highlighted the clinical utility of Invitae's test have given the firm strong ammunition to "sit down with payors and drive forward for contracts," he said.

GenMark Diagnostics

GenMark CEO Hany Massarany said that the firm has initiated analytical studies on its next-generation molecular diagnostics system called ePlex. It expects to launch the system, which combines its core eSensor electronic DNA detection technology with electrowetting sample prep technology, in Europe by the end of the current quarter. Massarany said the firm is on schedule to submit an application to the US Food and Drug Administration for the system in the second quarter of this year and anticipates clearance by the end of 2016.

The ePlex integrates sample prep, thereby providing a sample-to-answer workflow, and provides results in 60 to 90 minutes. GenMark is focusing the menu for the ePlex on infectious diseases and estimates the addressable market for those tests at around $2.3 billion. The firm is planning multiplex tests for gastrointestinal infections, sepsis, respiratory viruses, CNS (meningitis), hepatitis C virus, and fungal infections.

Massarany said in alpha studies on its respiratory virus panel, presented in 2015 at the Association for Molecular Pathology annual meeting, results showed high concordance with a respiratory panel sold by BioFire Diagnostics, a chief competitor. He said the study also showed the ePlex can run 120 samples per shift and demonstrated an ability to detect co-positive infections.

Massarany said he believes the new system will open up the firm’s potential customer base from around 1,000 labs in the US — the only market in which it sells its current XT-8 MDx system — to more than 10,000 labs globally.

He said GenMark plans to ramp up its US sales force later this quarter and in the second quarter to 35 to 40 reps. In Western Europe, the firm plans to sell directly, while forging distribution deals for Italy, the Nordic countries, and Eastern Europe.

Earlier this week, GenMark reported preliminary fourth quarter revenue of $13.2 million and full-year 2015 revenue of $39.4 million, a 35 percent and 29 percent year-over-year increase, respectively. It also said it placed 17 of its XT-8 systems in the quarter, bringing its total installed base for the instruments to 633.

Berry Genomics

Berry Genomics' CEO Daixing Zhou said that the company is making progress selling its noninvasive prenatal test as an in vitro diagnostic to hospitals in China. Of 108 hospitals that received approval by China's FDA to run NIPT, the firm is working with 62. Of those, 33 currently have the test up and running. In addition, he said that the Beijing-based company has grown to 900 employees, has established four certified reference laboratories in China to run the CFDA-approved test, as well as a medical device manufacturing facility. It also operates a laboratory in Taipei as well as a laboratory in Hong Kong that it established in conjunction with Dennis Lo of the Chinese University of Hong Kong.

Zhou said that a key component to moving from a centralized testing model to an IVD model where hospitals run the test themselves was to simplify the workflow. The bioinformatics, in particular, have been simplified so that it can run on a desktop computer and each sample takes just five seconds to analyze, he said.

Berry received CFDA clearance for its NIPT assay and a version of Illumina's NextSeq 500 sequencer instrument last year. Zhou said the company is now working on bringing additional tests in reproductive health and oncology through CFDA clearance.

Berry's NIPT assay looks for aneuploidies in chromosomes 21, 18, and 13 and Zhou said the company is working on expanding that assay. Already, expanded versions of the test are running at the laboratories in Taipei and Hong Kong. The lab in Taipei has added Turner syndrome as well as sex chromosomal aneuploidies, while the lab in Hong Kong is looking at 14 different indications, including some microdeletion syndromes.

NIPT in China is taking off, Zhou said. He predicted that in 2016, 750,000 NIPTs will be run in China, and that in 2020, NIPT will be run for half of the 10 million annual pregnancies.

Berry is also developing a technology to analyze single-gene disorders prenatally. Dubbed cSMART for circulating single-molecule amplification resquencing technology, Berry researchers published a paper in Clinical Chemistry in 2014 demonstrating a proof of concept for Wilson Disease in four at-risk pregnancies.

Zhou said interpreting pathogenic from benign variants is one of the main challenges in screening for single-gene disorders prenatally. To tackle this problem, the company partnered with Ali Baba to build a database with genomic data from 400,000 human genomes. "I think we have a complete set of Chinese genetic variants," Zhou said.

Finally, Berry is moving into the oncology space, developing a circulating tumor DNA test that will be based on the cSMART technology. The firm has developed a panel of nine genes that are relevant for non-small cell lung cancer patients and has tested it in over 100 patients, demonstrating that it is concordant with tissue-based biopsy. Berry is working with 10 hospitals in China to offer the test, which is designed to be used for molecular profiling to make treatment decisions, but Zhou said the firm is also working on a study to test the assay's ability to monitor disease burden.