SAN FRANCISCO (GenomeWeb News) – The 33rd Annual JP Morgan Healthcare Conference continued here Wednesday with presentations from several life science tools and diagnostic firms.
The following are capsules from the presentations and breakout sessions of Exact Sciences, Cepheid, Bio-Rad, Biocartis, and NanoString. Details of BGI's presentation, in which the company discussed its upcoming sequencing product launch and pending IPO of its sponout firms, is available here. Coverage of the first two days of the meeting can be found here.
Two days after announcing that it expects to report $1.5 million in revenue from its Cologuard colon cancer test for the fourth quarter of 2014, Exact Sciences presented at the JP Morgan Healthcare Conference on Wednesday, providing an update on its progress thus far with the test and some goals for 2015.
The noninvasive colorectal cancer test is the first and only US Food and Drug Administration-approved test screening DNA from stool samples. It received FDA approval in August, launched in the fall, and the Centers for Medicare and Medicaid Services has established a reimbursement rate of $493 for Cologuard on the clinical lab fee schedule.
Exact Sciences President, Chairman, and CEO Kevin Conroy said the firm has enrolled more than 9,800 physicians to offer Cologuard testing, of which 42 percent have ordered the test, and that number is "growing every day." He added that the number of physicians enrolled spiked after the firm gained CMS reimbursement.
Conroy said that the compliance rate among patients who receive the Cologuard test kit is around 75 percent. Exact Sciences has established a "patient engagement team," which calls on patients who are sent the kit but don't send in their sample. As an example of its effectiveness, Conroy said 37 percent of patients who received one compliance call returned their sample kit for testing.
The company also has expanded its sales force substantially over the past half year, from around 80 in August to around 140 sales people now.
For 2015, Conroy said Exact Sciences would focus on expanding its reach and frequency with physicians, and aims to enable physician ordering via electronic medical record systems. It also hopes that Cologuard will receive inclusion in the US Preventative Services Task Force guidelines later in 2015 or early 2016.
The firm also is just rolling out Cologuard testing in Europe after receiving the CE mark in December. And eventually, it aims to expand Cologuard's indication to high-risk patients and those patients between the ages of 40 and 50 years old – CMS covers average-risk patients between the ages of 50 and 85 years of age.
Conroy also noted that the firm will discuss coverage with commercial payers over the next year and has set a $599 price for the test, adding that the firm does not intend to offer the test at a discount, given its economic value and the cost that went into developing and running clinical trials on the test.
Cepheid CFO Andrew Miller highlighted the company's growing position in the molecular diagnostics space, saying it is the number two molecular diagnostics testing firm in the world, behind Roche.
With an installed base of more than 7,500 instruments, Cepheid has more platforms placed than any other MDx firm, he added, and in the US the company offers 16 tests, while outside the US it offers 20 tests. By the end of 2015, Cepheid expects to have 24 tests on the market internationally.
He noted that in infectious diseases such as methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, and Clostridium difficile, Cepheid has been growing its market share while competitors are either flat or losing share. With its leadership spot in molecular testing for infectious diseases secured, the firm is now looking at other areas, such as viral load testing and oncology, to grow its business, Miller said.
Viral load testing, he noted, has been a particular strength of Roche's MDx business, and one that Cepheid is just starting to enter. In December, the firm received the CE-IVD mark for the Xpert HIV-1 Viral Load assay and it is now eyeing a CE-IVD mark for the Xpert HIV Qualitative assay in Q1 or early Q2 2015. Within the same timeframe, Cepheid also anticipates receiving the CE-IVD mark for its HCV Quantitative assay.
Miller did not provide details about Cepheid's plans for the oncology space, though he said that the company's development of its Honeycomb cartridge technology, which would add multiplexing and the ability to quantify biomarkers to the GeneXpert platform, is progressing. The first test on the new technology will be for detecting breast cancer signatures and is targeted for a 2016 or 2017 launch.
In the fall Cepheid landed two US national reference laboratories as customers. Miller said during a question-and-answer session that the company is in discussions with a "very large" multinational reference laboratory in Europe for use of Cepheid's molecular tests. By 2017, the unnamed lab may offer a menu of 19 molecular tests, of which 17 could be Cepheid tests, Miller said.
Bio-Rad Laboratories President and CEO Norman Schwartz said that the firm is about a year away from commercializing its next-generation sequencing technology.
During his presentation, Schwartz said that there remains much work to do to get the technology, acquired in Bio-Rad's buy of GnuBio in April, to market. The focus now is in detailing the chemistries for the instrument, as well as doing work around the microfluidic cassettes, and nailing down target markers.
The foundation of the GnuBio system is a hybridization-based microdroplet sequencing technology, which uses a picoinjector method developed by David Weitz at Harvard University. The instrument will be used for targeted sequencing in the clinical diagnostics space, a market that Schwartz estimated at about $500 million and growing.
He added that the technology builds upon and complements Bio-Rad's expertise in DNA amplification and digital droplet PCR.
Upon launch of the instrument, Bio-Rad also plans to launch assays targeting the cancer space, though he declined to elaborate.
In September, Biocartis obtained CE-IVD marking for its Idylla molecular diagnostics platform and a BRAF mutation test. Today, Biocartis Chairman and CEO Rudi Pauwels spoke about additional assays that are planned to run on the platform.
The initial focus is on developing assays with existing biomarkers from solid biopsies. Along with the BRAF test, which detects two mutations, Biocartis anticipates launching assays this year for KRAS and NRAS. The KRAS assay would detect 21 mutations, and the NRAS assay would detect 19 mutations. One other assay for an undisclosed biomarker is also in the pipeline for launch this year, Pauwels said.
Starting next year, Biocartis' focus will include proprietary cancer biomarkers, he added. Further, he said that the company plans to develop technologies around liquid biopsies "with appealing characteristics."
Also among the company's goals are assays directed at infectious diseases, including flu, sepsis, and a respiratory mixed panel, Pauwels said.
Idylla was launched with pathology laboratories in mind as Biocartis' target customer for the platform. As it builds out its menu, other customers would include rapid response laboratories and microbiology labs. To date, the number of systems sold is in the tens, Pauwels said.
One week after announcing its preliminary fourth quarter and full-year 2014 revenues, NanoString Technologies CEO Brad Grey said the firm remains on track to launch in 2015 a third-generation nCounter system and proteomic applications for the platform.
The new nCounter system, which is planned for a launch in the first half of the year, will be lower throughput and lower priced than the existing nCounter and will be targeted to the individual researcher who may not need the full capabilities of the current platform or be able to pay for it.
Depending on how the system is used, the price for the current nCounter is about $235,000 to $265,000. Grey declined to disclose the price for the third generation system, which would be for research use only.
This year, NanoString also plans to release proteomic assays for use on the nCounter platform, which would allow researchers doing genomic research on cancer genes to simultaneously investigate proteins. The panels would have up to 30 proteins, which Grey said NanoString is in the midst of selecting. The proteins chosen will be initially based on the firm's cancer panels of more than 700 genes, Grey said.