We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Hologic: FDA Okays Procleix Zika Virus Test under IND Study
Read MoreHide Full Article
It’s raining opportunities for Hologic, Inc. (HOLX - Free Report) in the billion-dollar molecular diagnostics market. Soon after receiving an emergency authorization from the FDA for the use of its Aptima Zika Virus test, the company got FDA approval for its Procleix Zika virus blood screening assay.
Notably, this diagnostic test was approved under FDA’s Investigational New Drug (IND) study protocol to detect the presence of Zika virus in donated blood.
The Procleix assay, developed as part of Hologic’s long-standing partnership with Grifols and manufactured by the former, was originally used to screen donated blood for HIV, hepatitis B and C, West Nile and a handful of other viruses.
The Procleix Zika virus assay is an advanced version of this test, which now includes Zika virus as the criteria to be screened. As per terms of the IND study, the blood to be screened will be particularly collected from potential endemic areas in southern U.S., and may expand to other areas in the U.S. if the virus spreads.
Notable U.S. blood centers will run this test on Grifols’ Procleix Panther– a fully integrated and automated nucleic acid technology (NAT) system – for blood and plasma screening.
Although discovered in 1947, the public was alerted about the first confirmed Zika virus infection case in Brazil by the Pan American Health Organization (PAHO) in May 2015. On Feb 1, 2016, the World Health Organization (WHO) declared Zika virus a Public Health Emergency of International Concern (PHEIC).
So far, this virus has been predominantly affecting tropical countries. However, as of Jun 8, 2016, more than 691 confirmed cases of Zika have been reported in the continental U.S.
With the Centers for Disease Control and prevention (CDC) suspecting a Zika outbreak in new areas, the availability of the Procleix Zika virus blood screening assay, is expected to enhance Hologic’s shares in the molecular diagnostics market; which is projected to reach $9 billion by 2020.
Further, management believes that this approval reflects Hologic’s capability to quickly develop molecular diagnostics in response to new and emerging pathogens.
Interestingly, Hologic's competitor in the blood screening market, Roche, received IND for a Zika assay for blood screening in Mar 2016, indicating the gradual emergence of Zika virus tests in the molecular diagnostics space.
Hologic currently carries a Zacks Rank #3 (Hold). Better-ranked medical stocks are Baxter International Inc. (BAX - Free Report) , ICU Medical, Inc. (ICUI - Free Report) and LeMaitre Vascular, Inc. (LMAT - Free Report) . While Baxter holds a Zacks Rank #1 (Strong Buy), ICU Medical and LeMaitre carry a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Hologic: FDA Okays Procleix Zika Virus Test under IND Study
It’s raining opportunities for Hologic, Inc. (HOLX - Free Report) in the billion-dollar molecular diagnostics market. Soon after receiving an emergency authorization from the FDA for the use of its Aptima Zika Virus test, the company got FDA approval for its Procleix Zika virus blood screening assay.
Notably, this diagnostic test was approved under FDA’s Investigational New Drug (IND) study protocol to detect the presence of Zika virus in donated blood.
The Procleix assay, developed as part of Hologic’s long-standing partnership with Grifols and manufactured by the former, was originally used to screen donated blood for HIV, hepatitis B and C, West Nile and a handful of other viruses.
The Procleix Zika virus assay is an advanced version of this test, which now includes Zika virus as the criteria to be screened. As per terms of the IND study, the blood to be screened will be particularly collected from potential endemic areas in southern U.S., and may expand to other areas in the U.S. if the virus spreads.
Notable U.S. blood centers will run this test on Grifols’ Procleix Panther– a fully integrated and automated nucleic acid technology (NAT) system – for blood and plasma screening.
Although discovered in 1947, the public was alerted about the first confirmed Zika virus infection case in Brazil by the Pan American Health Organization (PAHO) in May 2015. On Feb 1, 2016, the World Health Organization (WHO) declared Zika virus a Public Health Emergency of International Concern (PHEIC).
So far, this virus has been predominantly affecting tropical countries. However, as of Jun 8, 2016, more than 691 confirmed cases of Zika have been reported in the continental U.S.
With the Centers for Disease Control and prevention (CDC) suspecting a Zika outbreak in new areas, the availability of the Procleix Zika virus blood screening assay, is expected to enhance Hologic’s shares in the molecular diagnostics market; which is projected to reach $9 billion by 2020.
Further, management believes that this approval reflects Hologic’s capability to quickly develop molecular diagnostics in response to new and emerging pathogens.
Interestingly, Hologic's competitor in the blood screening market, Roche, received IND for a Zika assay for blood screening in Mar 2016, indicating the gradual emergence of Zika virus tests in the molecular diagnostics space.
Hologic currently carries a Zacks Rank #3 (Hold). Better-ranked medical stocks are Baxter International Inc. (BAX - Free Report) , ICU Medical, Inc. (ICUI - Free Report) and LeMaitre Vascular, Inc. (LMAT - Free Report) . While Baxter holds a Zacks Rank #1 (Strong Buy), ICU Medical and LeMaitre carry a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>