SAN FRANCISCO (360Dx) - The 36th annual JP Morgan Healthcare Conference kicked off here on Monday with some of the biggest players in the molecular diagnostics industry presenting. Below are brief reports on the presentations and breakout sessions covered by our team at the conference.
Following an expected profitable 2017, Genomic Health CEO Kim Popovits said that the company expects to record another profit in 2018 fueled by anticipated double-digit growth in 2018 revenues.
During her presentation, Popovits laid out several drivers to top-line growth. For the firm's Oncotype Dx breast cancer recurrence test, she noted the recent reimbursement rate established for the test by the Protecting Access to Medicare Act, which increased the reimbursement for Genomic Health's test by more than 10 percent, prompting Popovits to call PAMA a "win" for Oncotype DX. The new rate was implemented on Jan. 1.
She also pointed to the American Joint Committee on Cancer's incorporation of the test in its staging manual, which took effect on Jan. 1, and the TAILORx trial, which, in addition to potentially driving up penetration in the US market, is anticipated to increase Genomic Health's footprint overseas, particularly in Germany, Japan, Italy, Canada, France, Spain, and the United Kingdom.
In September, the company and Biocartis announced a deal to develop an in vitro diagnostic version of the Oncotype DX breast cancer test on Biocartis' Idylla platform. Popovits said today that the company expects to make the product available starting next year in France and Germany. Additionally, Genomic Health is eyeing Brazil, Russia, India, and China as potential markets for the test.
On the firm's other tests, Popovits said that the National Comprehensive Cancer Network is expected to issue stronger guidelines this year for prostate cancer testing, which should support adoption of and reimbursement for the Oncotype DX GPS test for that indication. Meanwhile, the Oncotype DX AR-V7 test will be launched in the current quarter, and Medicare reimbursement for the test is expected to come around the middle of the year, Popovits said.
The firm also has in its pipeline the Oncotype DX IsoPSA for predicting high-grade prostate cancer before biopsy. Popovits said that a validation study for the test should be completed in the first half of this year, and she highlighted that it will be an IVD test that will allow pathologists to run the test using the same patient sample and workflow that they currently use for PSA tests.
Genomic Health Chief Business and Product Development Officer Fred Pla noted that the company believes international markets, including parts of Europe, China, Latin America, and India could be robust IVD markets for the company.
Company officials also suggested that the firm may be on the lookout for possible acquisitions, something that it historically has not been active in. But having reached profitability, with a defined focus on the oncology and urology spaces, and the forging of the Biocartis IVD deal, Genomic Health believes "now is the time" to bring in new technologies, particularly molecular methods, Popovits said.
Last month, Bloomberg reported Genomic Health was exploring strategic alternatives, including a possible sale or takeover of the firm. Popovits on Monday declined to comment about the report.
In advance of a presentation by Troy Cox, Foundation Medicine's CEO, the firm reported preliminary fourth quarter revenues that were 70 percent higher than the fourth quarter the previous year. The revenues of $48.9 million were well above analysts' average estimate of $39.2 million.
As Cox noted, among the firm's most biggest accomplishments this past year was the FDA approval of its FoundationOne CDx (F1CDx), which concurrently received a preliminary national coverage determination from the US Centers for Medicare and Medicaid Services (CMS) under the parallel review program. The comment period for the NCD is ongoing and will close later this month, with a final decision expected to be issued in February.
F1CDx detects genetic variants in 324 genes known to drive cancer and looks for two genomic signatures — microsatellite instability (MSI) and tumor mutational burden (TMB) — in solid tumors of any type, which may help doctors with the clinical management of cancer patients according to professional guidelines. It is the companion diagnostic version of its FoundationOne test, which has been launched in 27 countries worldwide thus far.
The NCD covers five tumor types: ovarian, lung, breast, colorectal, and melanoma. But Cox said it will be an expandable NCD, and Foundations aim is to make the test a universal platform for CDx development that is "evergreen" in nature, frequently being updated. He added that one of the company's growth pillars is shaping the targeted and immunotherapy landscape with new and emerging biomarkers.
While Foundation Medicine expects F1CDx to see an increase in revenues after the NCD is finalized and as the year progresses, the price CMS will reimburse remains uncertain. According to JP Morgan analyst Tycho Petersen, Foundation Medicine management has said that an "amount in the $2,500-3,400 range would be within the range of acceptable outcomes."
The landscape among commercial payors is a little murky and will partly depend on the tet's inclusion in National Comprehensive Cancer Network guidelines. The firm doesn't know the timing of when that will happen, and Cox noted that NCCN currently still makes decisions by tumor types.
Cox also highlighted the company's strong 2017 growth in revenues derived from pharma partners, $99.7 million compared to $78.8 million in 2016.
Cox said F1CDx is the firm's top priority in 2018, but it is expected to help with sales of the company's other tests including FoundationHeme and FoundationACT, its 62-gene cell-free DNA mutation test launched in 2016. He also said the firm has plans to expand its global footprint this year and strengthen its commercial capabilities with an expanded management team.
Before its presentation on Monday, Qiagen announced a deal to make its QuantiFeron-TB Gold Plus available for use on DiaSorin's Liaison family of automated analyzers.
In their joint announcement, the firms suggested the agreement could increase adoption of Qiagen's test for latent tuberculosis, but during the firm's breakout session on Monday, Qiagen CEO Peer Schatz said a projection of the deal's effect on Qiagen's revenues has not yet been determined.
The firm also said that it plans to launch the test, which is a fourth generation of the QuantiFeron-TB test, in Japan soon. Qiagen initially launched it in the US in October.
Qiagen also announced an update on Monday on its next-generation sequencing business, saying it has a goal of more than $140 million in sales for the year, compared to more than $115 million in 2017. The firm added it will launch a new enterprise genomics services offering for the customization of gene panels, and announced it plans to build up its portfolio of multiplex QIAseq NGS panels for use on any NGS sequencer.
During the firm's Q3 2017 announcement, CFO Roland Sackers said that Qiagen was "divesting the distribution of our China HPV franchise" to a third party "to improve our competitive position through a more tailored product offering and better adapt to local market needs." Schatz added on Monday that Qiagen will supply its HPV products to a newly created company in China, which will then resell them.
Following on earlier comments that Qiagen would discontinue some "non-core" PCR-based diagnostic tests. Schatz said at JP Morgan that those products had sales in the single-digit millions of dollars. The company will provide additional details about those tests during its Q4 2017 release and conference call, he said.
Lastly, Schatz said that Qiagen has set a goal of 2,250 cumulative placements in 2018 for the QIAsymphony platform. A few months ago, it announced it had exceeded 2,000 placements,
Though Myriad Genetics' hereditary cancer testing revenues have been declining for several quarters, President and CEO Mark Capone noted in his presentation that the decline has been offset by volume gains. He also noted that through contracts with payors, the firm also has pricing predictability through 2020.
But as its legacy hereditary cancer business has faced increasing competition, Myriad has responded in recent years with acquisitions and new product launches that have expanded its portfolio. The most recent of these launches is its 86 SNP breast cancer riskScore test to help inform the care of the large proportion of women who lack mutations in well-known cancer-linked genes. The test is an adjunct to myRisk, its next-generation sequencing panel that gauges 28 genes associated with elevated risk for eight hereditary cancers.
Capone pointed to the variety of tests the firm now offers including myRisk, its GeneSight neuropsychiatric pharmacogenetic test, Prolaris, Vectra DA, EndoPredict, and myPath Melanoma. According to Capone, most of those tests are still in the early stages of market penetration, often less than 10 percent of their total addressable market. And, among its tests, he said the hereditary cancer test and EndoPredict are the only ones that are fully reimbursed.
Myriad is hoping that increased reimbursement and adoption of its tests will drive gains in the years to come, and Capone noted that if its tests were fully reimbursed, the firm would have recognized revenues of greater than $1.1 billion in FY 2017 versus the $771.4 million it reported.
In particular, Capone was bullish on the prospects for the firm's GeneSight test, for which it expects double-digit volume growth in FY 2018. The test was one of several included in a long-term pricing agreement with insurer UnitedHealthcare last June. However, UHC has yet to make a coverage decision on the test.
He also said the firm aims to increase sales of its RNA kit products (EndoPredict, Prolaris, and MyPath Melanoma) internationally to increase revenues, while improving profitability through its 'Elevate 2020' project.
Like other companies presenting on the first day of the conference, Myriad officials said there would be a material upside from the new US tax law that will drop Myriad's tax rate from 35 percent to 20 percent. They didn't quantify that benefit, but said they will provide updated guidance during their next quarterly call.
Guardant Health CEO Helmy Eltoukhy said during the liquid biopsy company's presentation that it is plans to submit to the US Food and Drug Administration a liquid biopsy assay, Guardant360IVD, by the end of 2018.
The firm has also developed a liquid biopsy assay that analyzes more than 500 genes, GuardantOMNI, which it launched in the second half of 2017 and has so far seen "higher than anticipated demand."
GuardantOMNI is the firm's second product after Guardant360, a liquid biopsy assay it launched in 2014 that analyzes 73 genes. Eltoukhy said that both the firm's clinical and biopharmaceutical partnership businesses have grown. In 2017, it ran 32,000 samples, up from 21,000 in 2016 and 12,000 in 2015. It receives orders from more than 4,000 oncologists, about half of whom are community oncologists. And among National Comprehensive Cancer Network designated facilities, there is over 90 percent adoption of Guardant360.
While Guardant360 can address the metastatic cancer patient market of about 1.65 million patients in the US, Eltoukhy said that the firm's previously announced Project LUNAR would help move the company into markets for recurrence monitoring and adjuvant decision making for the 13.8 million cancer survivors in the US.
Ultimately, Guardant's goal is to develop a liquid biopsy for early cancer detection in asymptomatic individuals who are at a high risk of developing cancer. To do this, it is expanding from analyzing only genetic alterations in circulating tumor DNA, to also looking at epigenetic and immune signatures, Eltoukhy said. In addition, he said, the firm calculated that it would need 10 times the amount of data it has generated thus far.
He said that the $360 million it raised last year from lead investor SoftBank and the establishment of a joint venture in Singapore was one step toward building up that data. He noted that already the firm has initiated clinical trials in Japan that all 250 of the country's cancer centers are participating in. "With this expanded global reach, we'll accelerate the rate of data acquisition," he said.