NEW YORK (GenomeWeb News) – Investment analysts have weighed in on the US Food and Drug Administration's clearance of Gen-Probe's Aptima HPV assay, saying that they expect a modest revenue contribution in 2012 but a potentially significant ramp in sales over the following two years.
Gen-Probe announced this morning FDA clearance of the molecular assay, which will run on the firm's fully automated, high-throughput Tigris system. The test detects 14 high-risk HPV types associated with cervical cancer and precancerous lesions, but unlike other FDA-cleared tests detects messenger RNA over-expressed from two viral oncogenes that are integral to the development of cervical cancer.
The unique nature of the test could contribute to a longer adoption period, as physicians will need to be educated about the test. Gen-Probe said that it expects to launch the test within two weeks, but it doesn't anticipate revenues until late in the first quarter of 2012.
In a research note following Gen-Probe's announcement Jefferies analyst Jon Wood said that he expects the Aptima HPV test to gain roughly 1 percent of the roughly $300 million US HPV test market in 2012, which would equate to revenues of around $4 million. However, he models an 8 percent capture of a $500 million market for 2014 — or roughly $40 million.
Those estimates fall below the expectation of Oppenheimer's David Ferreiro, who has provided an estimate of $20 million in revenues for the HPV test in 2012, followed by $65 million in 2013.
Several analysts noted the placement of more than 200 Tigris systems on the market, which should help Gen-Probe with uptake of the test. In addition, they also cited slightly better specificity of the Aptima test in clinical studies compared with the clear-cut market leader, Qiagen's Digene HPV test. Hologic also offers two molecular tests for HPV — the Cervista HPV HR (high risk) and Cervista HPV 16/18 tests — which were cleared by FDA in early 2009.
Dan Leonard, an analyst with Leerink Swann, said that he expects Qiagen to retain most of its business from Quest Diagnostics, Laboratory Corporation of America, and Kaiser, which combined provide 70 percent of US HPV test sales for Qiagen. "We believe that [Qiagen] will be able to counter detail the performance of the [Gen-Probe] test (arguing lower sensitivity) with some effectiveness," he wrote.
Leonard also said he expects the Gen-Probe test to be priced at a premium to Qiagen's test.
The Aptima HPV assay is expected to be one of the key future revenue drivers for Gen-Probe, and it is expected to offer synergies with the firm Chlamydia/Gonorrhea testing franchise. The company also is awaiting FDA clearance of its Panther molecular diagnostics system.
Despite the FDA clearance of the Aptima assay Gen-Probe's shares were down 2 percent at $60.40 around 10 minutes before the close of the market Monday, matching a decline in the broader market.