NEW YORK (GenomeWeb) – With two Zika tests receiving different types of authorizations in four days, Hologic plans to build on its established channels in women's health and the blood screening markets to distribute them.
Hologic's Zika test for patients who meet certain criteria was granted Emergency Use Authorization by the US Food and Drug Administration late last week, while a blood screening assay for the virus was approved for use under an Investigational New Drug study protocol yesterday.
"It took long hours, and I'm exceptionally proud of the team for what they've done to get us in a position where we can serve a very real public health need," Tom West, division president of diagnostic solutions at Hologic, told GenomeWeb.
Development of the Zika tests was motivated by ongoing conversations with the US Centers for Disease Control and Prevention and the FDA, West added.
"Given the size and role of our blood screening business, our ability to leverage that into the EUA as a diagnostic opportunity, as well as our commitment broadly to women's health, it seemed like a very appropriate and good fit, one that we wanted to pursue, and one that we were encouraged to pursue," he said.
With a molecular test menu of mainly women's health assays, Hologic has a two primary sales forces, West said, one that calls on physicians and the other that calls on labs. Its Ob/Gyn sales force calls directly on obstetricians and gynecologists, and reps can provide education on guidelines, "hopefully to dispel some of the undue anxiety but at the same time to make sure that people are taking the right steps if patients are either clinically or epidemiologically appropriate for testing," West said.
Mike Watts, Hologic's vice president of investor relations and corporate communications, noted that under EUA there are fairly strict circumstances under which the test is approved to be used. "This is not a test, for example, for all pregnant women," he said, but rather for women who show symptoms of Zika or have traveled to Zika-infested areas.
For lab sales, the firm will rely on its installed base of Panther systems. Watts noted that "there are several hundred of those in the field in the US" currently. West added that the vast majority of mid- to large-size labs have Panther systems already, and the firm will now be "alerting them as to the availability of the [Zika] assay for use on their existing machinery."
Hologic's core molecular technology is a proprietary chemistry called transcription-mediated amplification, or TMA. It is particularly sensitive relative to other technology platforms, West said, making it well suited to this particular utilization. "We can find and detect even very small amounts of the presence of Zika — that's why it works well in both Procleix blood screening as well as on the Aptima for diagnostic purposes."
Hologic utilizes TMA in other Procleix blood screening system assays, including an HIV, HCV, and hepatitis B virus triplex assay that is currently used by the American Red Cross to screen blood donations.
Recent reports have also touted TMA in the firm's Aptima line of molecular diagnostic tests. A hepatitis C viral load test fared well in a recent evaluation, showing a slight edge in sensitivity at low viral loads compared to another commercially available molecular test. And a recent economic model of human papillomavirus cervical cancer screening simulated co-testing with Hologic's Aptima test because of its specificity, with the author noting that other commercial tests "would not give the benefit of the specificity parameter, and therefore benefits of co-testing would be eroded."
The technique has limits of detection down to 5 viral particles in a milliliter of blood, Watts said. "When you combine that with the automation of the platform, we think it will be appealing to labs," he added.
The current economic opportunity for the EUA Zika test for patients may not be large, West suggested, but the test will "contribute to addressing the public health hazard" of Zika virus. It was also developed from the blood screening test, which may have a larger opportunity for financial gain, depending on whether Zika virus incidence increases in the US.
Indeed, Piper Jaffray analyst William Quirk wrote in a note to investors yesterday that the monetary benefit from Aptima Zika may be relatively limited. Immediate impact of blood testing in the Southern US may also be fairly modest, but if the virus spreads via a second identified mosquito vector, "revenue benefit could be $13 to $25 million."
And if the blood screening test is ultimately approved by the FDA and there is a national screening policy, it could add up to $39 million to Hologic's blood screening business, he suggested.
"Given the ongoing epidemic in Puerto Rico (1,350 people infected, [and] CDC expects 25 percent of the population to be infected by the end of 2016), the number of people traveling from Zika-infected zones (40 million annually) and the upcoming summer (with now two mosquitoes probably spreading Zika), we believe the odds of the American Red Cross and America's Blood centers expanding screening to the entire US is high," Quirk wrote, adding that the investment firm believes Hologic controls 85 percent of the blood screening market.
West pointed out that there are two primary companies that do blood screening in the US as well as globally — Hologic and Roche. "We have a slight global advantage in terms of market share; we have a stronger advantage here in the US thanks to relationships like that with the American Red Cross," West said.
Roche's blood screening test for Zika was approved to screen donated blood samples under an IND application protocol earlier this year, and is currently being used in Puerto Rico. It was described by the CDC last week as "extremely accurate" and as providing information on Zika rates in that territory.
However, competition in the blood screening space wasn't the driving force behind Hologic's test development. "There wasn't a specific motivation about having a Zika IND as a source of immediate competitive advantage," West said. "Rather it was really in working with CDC and FDA, at their request, knowing that our technology could be instrumental, that we made the choice to go forward with it. It is obviously important to have broad menu in any competitive setting, but that was secondary to our thinking that we were in a position to be able to help out."