NEW YORK (GenomeWeb) – Wednesday marked the start of the annual UBS Global Life Sciences Conference here with a number of companies in the 'omics-related life science tools space making their pitches to investors.
Below are highlights from companies that presented yesterday.
One week after the launch of the Ion Torrent Proton, much of the investor focus was on that business, and during his presentation Life Technologies Chairman and CEO Greg Lucier said that by the end of the year the firm expects to reach break-even with the Ion Torrent business, "so we're very bullish" on its effect on Life Tech's margins.
Company officials declined to disclose projected revenue figures from Ion Torrent for 2012 but said that it will surpass the $70 million recorded last year.
Life Tech previously has said that it will submit the Ion Proton for US Food and Drug Administration clearance, and Lucier said yesterday that that will likely happen in 2013. He added the company also will submit the Ion Torrent Personal Genome Machine with FDA "shortly."
As adoption of the Ion Torrent platforms ramp up, adoption of Life Tech's SOLiD benchtop sequencing platform is headed in the opposite direction, though Lucier said the system is still "widely used." The company has continued to make improvements to the platform, and in the spring launched its Wildfire sample prep technology for the SOLiD 5500.
But of the SOLiD business, Lucier said, "You should look at it as a diminishing revenue source over the [next few] years."
Life Tech has recently built out its diagnostic and medical segment with the purchases of Navigenics and Pinpoint Genomics, and most recently it inked a companion diagnostics deal with Bristol-Myers Squibb. The company's strategy to continue building that franchise will include additional acquisitions, Lucier said, with an emphasis on informatics and an expansion of its menu of disease states.
Lastly, with the threat of sequestration resulting in a possible cut of about 8 percent to the National Institutes of Health's funding, Lucier said that if that were to happen, the effect on Life Tech's business would be a drop in revenues of 1 percent, which he called "manageable." He also expressed optimism that any cut to NIH will be avoided as there is strong bipartisan support in Congress for the agency.
Company officials provided some details about its purchase of BlueGnome, announced yesterday — a deal that provides Illumina with access to the pre-implementation genetic screening space. Additionally, the acquisition provides Illumina with BlueGnome's array-based cytogenetics test.
BlueGnome will become part of Illumina's diagnostics business and will operate "pretty much" as a standalone operation, Illumina General Manager Christian Henry said. Over time, Illumina's technology will be integrated into BlueGnome's workflow, but more immediately, the Cambridge, UK company's BlueFuse software product will be integrated into Illumina's product offerings, he added.
Henry also reiterated planned product launches, including TruSight targeted sequencing kits for the MiSeq. TruSight kits for cancer and exome sequencing are planned for October releases, while kits for autism and inherited disease will be released in November.
Also, the HiSeq 2500 will begin shipping in the fourth quarter as planned.
During the summer the company launched its BaseSpace cloud computing and storage platform. The product is already connected to the MiSeq system, and early in the fourth quarter it will also be connected to the HiSeq, Henry said.
Lastly, Illumina's App store will be launched in the fourth quarter, with pricing determined on a pay-as-you-go basis, based on how a customer uses the app.
On Monday, BGI announced an agreement to purchase Complete Genomics for $117.6 million. But any effect to Illumina may be minimal, said Henry, adding that Illumina has demonstrated that it can compete effectively against Complete Genomics and the company will be able to compete with BGI on price points.
Additionally, he noted that Illumina can now do whole-genome sequencing with a two-week turnaround time with its Individual Genome Sequencing services, which investment bank RW Baird recently said "raises the bar on whole genome turnaround time."
Thermo Fisher Scientific bought transplant diagnostics company One Lambda, Luminex's biggest customer, in July for $925 million. At the conference, Luminex President and CEO Patrick Balthrop said the deal could be a positive for his firm as the deal combines Thermo Fisher's operational expertise with One Lambda's R&D expertise in the transplant diagnostics space.
Thermo Fisher, Balthrop said, will now have an enhanced opportunity to grown One Lambda's market and its leadership in that space.
Also in July Luminex completed its buy of molecular diagnostics shop GenturaDx for $50 million, a transaction that allows Luminex to target the low- to mid-volume MDx testing space.
GenturaDx is developing a real-time PCR system called the IDbox System. At last year's UBS conference, GenturaDx laid out a timeline for anticipated launches of its assays in development. The company also said then that among the tests in development were ones for herpes simplex virus, C. difficile, and a respiratory panel.
Balthrop, however, said that that timeline is no longer relevant and that the IDbox system and certain assays are targeted for a 2014 launch. He declined to identify the assays that are expected to be launched in conjunction with the system, but said that they will be in line with Luminex's current lineup, a combination of genetic and infectious disease tests.
Since acquiring GenturaDx, Balthrop said, the headcount at GenturaDx has been reduced to the single digits and its R&D operations has been consolidated with Luminex Madison in Wisconsin, which was formed when Luminex acquired Eragen in 2011.
Roland Sackers, CFO of the firm, reiterated the company's plans to file for regulatory approval from FDA for its artus CMV assay (PMA); the QuantiFeron CMV assay (510(k)); and therascreen EGFR (PMA), as well as goals for CE-IVD marking for the artus CT/NG panel and therascreen BRAF assay.
The QuantiFeron technology was acquired by Qiagen when it bought Cellestis for $374 million in 2011. Along with the cytomegalovirus assay, the purchase gave Qiagen the FDA-approved QuantiFeron-TB Gold-in-Tube test for latent tuberculosis.
Company officials said that for 2013, the target is to sell 50 million of the TB tests. Cepheid markets its Xpert MTB/RIF test for TB and recently signed the first of several anticipated agreements to make the test available at a discounted price in resource-poor nations.
John Gilardi, vice president of corporate communications and investor relations for Qiagen, said that the QuantiFeron TB test does not compete with the Cepheid test and will be targeted to healthcare employees working in large healthcare centers.
On the HPV front, the market is playing out "as we anticipated" Gilardi said, with a "bleeding off," though he added that the drop in HPV sales is manageable.
During Qiagen's second-quarter earnings conference call, company officials said that the HPV market would not be a growth driver in 2012, and in the US, where HPV represents about 14 percent of the company's total revenues, HPV sales are anticipated to retreat in the single digits.
In June, the company received clearance from FDA to market its Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) on its Verigene System, and President and CEO William Moffitt said at the UBS conference that he is "reasonably confident" that before 2012 ends Nanosphere will also get clearance from the agency to market its test for clopidogrel metabolism, although FDA turned down the company's PMA for the assay in June 2011.
The firm has a target goal of placing between 40 and 60 Verigene systems in the third quarter and Moffitt said that it remains comfortable it will meet that figure. In the fourth quarter, he added, between 60 and 80 placements are projected.
The firm's assay-development focus continues to be microbiology, Moffitt said, and will remain so until Nanosphere reaches break-even. But in the meantime, it is also developing a troponin assay that has a potential market opportunity of between $500 million and $1 billion. The assay has two potential uses: in hospitals to rule out myocardial infarction in patients and to monitor chronic heart failure patients.
Until Nanosphere accomplishes break-even, Nanosphere will only minimally market the troponin assay, Moffitt said, because it doesn't have the sales resources to do more.
The firm has eight sales representatives and is in the process of building up its sales force. It plans to have about 12 salespeople within 30 days.
As patient enrollment for Exact Sciences' clinical trial for its Cologuard colorectal cancer screening test comes to an end in the current quarter, the company anticipates a submission to the FDA of its first module for regulatory approval, followed by a submission of its clinical module in the first quarter of 2013, company President and CEO Kevin Conroy said.
The trial, called DeeP-C, will include 10,000 patients, of which data has already been obtained for 7,000 patients, Conroy said.
Upon FDA approval, the commercialization strategy will be to market Cologuard to large healthcare systems in the US that have their own gastrointestinal practices. Conroy added that Exact Sciences is considering creating its own laboratory to offer the test, but it does not see a big role for large outside labs such as Quest Diagnostics or Laboratory Corporation of America to market Cologuard because of discounts to a test's sales price and cuts they take from any sales.
Next year, the company expects the test to receive CE marking. It is also in the process of recruiting key opinion leaders in Europe for a study on Cologuard next year, Conroy said.
The firm continues to gather data on a head-to-head comparison of its Epi proColon colorectal cancer test with fecal immunochemical testing and anticipates the study to be finished in the fourth quarter. It will then file the fourth and final module of the PMA for the test with the FDA, Epigenomics CEO Geert Nygaard said.
Unlike Exact Sciences' Cologuard, which is often compared to Epi proColon, Nygaard said that his firm's test – which is available in Europe and in the US as an LDT through Quest – targets the approximately 30 million Americans who should be getting a colonoscopy but don't.
Exact Sciences' test is meant as a complement to colonoscopies, not as a replacement.
Additionally, Epigenomics' test could have use for testing in the intervals between colonoscopies, a market that company officials estimated at 37 million Americans.
Commercialization of the real-time PCR-based test, if and when it receives FDA approval, would follow a three-pronged approach. Epigenomics will sell to about 200 laboratories that it has identified, Nygaard said. Afterward the company will target physicians directly, followed by direct marketing to consumers with the help of colon-health patient advocacy organizations.