SAN FRANCISCO (GenomeWeb News) – The 32nd Annual JP Morgan Healthcare Conference concluded here Thursday with presentations from several life science tools and diagnostic firms.
The following are capsules from the presentations and breakout sessions of Affymetrix, Exact Sciences, and Fluidigm.
A week after pre-announcing fourth quarter revenues of $91 million, an 8 percent year over year increase, Affymetrix President and CEO Frank Witney said at the conference Thursday that the firm is aiming for revenues of $335 million for FY 2014, up from an estimated $329 million for FY 2013.
He declined to provide a breakdown of the revenues for 2013 but noted continual growth of its CytoScan products for clinical cytogenetics. Witney noted that CytoScan sales were up 35 percent through the first three quarters of the year, as the firm awaits a decision from the US Food and Drug Administration on a 510(k) submission for CytoScan that was filed in February 2013.
He said that the Affy's installed base for CytoScan in the post-natal market grew 40 percent in 2013. Longer term, Witney said the firm would look to expand its cytogenetics business in cancer and reproductive health.
Affy officials said that the company has been taking market share from Agilent in the cytogenetics market, with Affy COO Andy Last adding, "Momentum is in our favor."
Witney also cited a growing interest in the company's Axiom genotyping products on the part of pharma partners. During a Q&A session following the presentation, Last said pharma partners have become more interested in the firm's high-throughput genotyping systems as prices have come down. He noted that prices have dropped to around $50 a sample from $300-$500 just a few years ago.
Though company officials declined to name any of the pharma partners, Last said one of the reasons pharma partners and CROs are using the high-throughput genotyping systems is to profile their own biobanks.
Affy officials also said the firm's presence in the ag-bio sector is rapidly growing, and that market is relatively unpenetrated. Last said that Affy's products are particularly suited to the complex genomes in the ag-bio space, adding, "We've got the price point and the throughput.
The firm unveiled a variety of high-density SNP genotyping arrays this week at the Plant and Animal Genome Conference.
Affy is scheduled to report its Q4 and FY 2013 financial results on Feb. 5.
As Exact Sciences awaits a decision by the US Food and Drug Administration on its premarket approval application for its Cologuard colorectal cancer test, President and CEO Kevin Conroy mapped out the company's potential commercialization strategy.
The focus will be on doctors it has identified as high prescribers of colonoscopies and fecal immunochemical testing, as well as on large healthcare systems.
Exact Sciences has identified 5,000 doctors that are responsible for approximately 2 million colon screening tests per year in the US. Each sales representative will be charged with converting at least 50 of these doctors from existing testing methods to Cologuard, Conroy said. Another 12-person sales team will simultaneously direct its efforts at healthcare systems.
Conroy said that based on internal market research, Exact Sciences believes the conversion rate for Cologuard could be high, as 96 percent of physicians have told the firm they are either very or moderately likely to prescribe the test. At the same time, 92 percent of patients said in a company survey that they would use the test.
Exact Sciences is scheduled to meet with FDA in late March to review the company's PMA submission. Simultaneous with the submission, the firm is pursuing reimbursement from the Centers for Medicare and Medicaid Services as part of a joint FDA-Medicare parallel review program.
Based on a crosswalk analysis of the billing codes for Cologuard's components, the firm estimated the total reimbursed value of the test to be about $476, though the actual reimbursement amount may be different.
Conroy added that while Cologuard is currently directed at patients at average risk for colorectal cancer, it may be developed in the future for those at higher risk, such as those with a family history of the disease, or who have had polyps in the past. The company also continues to evaluate methods of further increasing the accuracy of the test.
In Exact Sciences' Deep-C clinical trial, Cologuard had 92 percent sensitivity and 87 percent specificity. With patients who had polyps at least 2 centimeters in size, the test showed 66 percent sensitivity, Conroy said.
This year, the menu for Fluidigm's C-1 instrument will be expanded to include single-cell exome sequencing and single-cell whole genome sequencing, President and CEO Gajus Worthington said.
As a result, the platform, which was launched in 2012, will have six capabilities, including single-cell targeted gene expression; single-cell mRNA sequencing; single-cell miRNA analysis; and single-cell targeted DNA sequencing.
Worthington said that the firm has two market opportunities: single-cell genomics and production genomics. The single-cell genomics space has grown in explosive fashion, he said, noting that it could be a $450 million market by 2017, compared to $50 million in 2012.
Revenues for Fluidigm's single-cell genomics business almost doubled in 2013, comprising about half of the company's total product revenues, he added.
Production genomics, meanwhile, is about a $285 million market with the biobanking space estimated at $100 million. Ag-bio is worth about $95 million, clinical laboratories about $65 million, and HLA typing $25 million, Worthington said.
Unlike the single-cell genomics market, which is instrument weighted, production genomics is a consumables-centric market, Worthington said. In 2013, production genomics was a "major" contributor to the company's consumables growth, and the two markets together offer Fluidigm a symbiotic revenue stream, he said.
Earlier in the week, the company reported $21 million in preliminary fourth quarter revenues, which would be up 34 percent from the year-ago figure of $15.7 million.