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News Breaks
January 7, 2014
09:53 EDTOSUROraSure says subsidiary DNA Genotek received FDA warning letter
OraSure Technologies announced that its molecular collection systems subsidiary, DNA Genotek, received a warning letter from the U.S. Food and Drug Administration which the FDA posted today on its website. The warning letter primarily focuses on DNA Genotek's response to two observations issued by the FDA on Form 483 as a result of a routine inspection of DNA Genotek's Ottawa, Canada facilities in September 2013. DNA Genotek is actively engaged and working with the FDA to address the agency's observations and will continue to sell and market all of its products while responding to the warning letter. No material impact to product sales or OraSure's consolidated financial performance is expected as a result of the issues raised by the warning letter. The warning letter requests additional documentation related to finished product acceptance testing activities for DNA Genotek's ORAcollect OC-100 collection device, a swab-like product with a small customer base that accounted for approximately one-half of one percent of OraSure's consolidated revenues in 2013. The letter notes that DNA Genotek does not currently have in place an approved premarket approval application or 510(k) clearance for its ORAcollect OC-100 device. In addition, the warning letter indicates the need for additional documentation regarding design and development activities for DNA Genotek's products and focuses in particular on the design planning and design history file for its 510(k) cleared OrageneDx collection device, a product primarily used in commercial applications. A product similar to OrageneDx, sold under the name OrageneDiscover, is used primarily for research applications and was not specifically addressed by the warning letter.
News For OSUR From The Last 14 Days
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February 3, 2016
16:56 EDTOSUROraSure sees Q1 EPS 1c-2c, consensus 1c
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16:55 EDTOSUROraSure reports Q4 EPS 8c, consensus 3c
Reports Q4 revenue $32.4M, consensus $29.73M.
February 2, 2016
12:56 EDTOSURMizuho downplays near-term Zika revenue potential for NewLink, Intrexon
The Zika virus and its link to microcephaly and fetal brain damage have exploded into public view and lead to several drugmakers announcing plans to fight the disease, but Mizuho analyst Eric Criscuolo downplayed the potential for Zika to truly move the needle for companies in the space in the near-term. PERIPHERAL OPPORTUNITIES: NewLink (NLNK) announced plans to develop treatment options for the Zika virus as the disease was declared a global health emergency by the World Health Organization this week. While the company "could" secure funding and partnerships for the project, Criscuolo does not view NewLink's Zika plans as core to its investment story, encouraging investors to instead evaluate the company on the basis of its HyperAcute and IDO programs. Meanwhile, Intrexon's (XON) efforts in mosquito population control have also gained attention amid the rise of Zika, whose primary transmission vector is the mosquito. Though even a small slice of global mosquito spending would represent "significant" revenue for Intrexon, Criscuolo cautions that the company's program is still in early stages, with attempts at a wider rollout likely encountering political, biological, financial and public opinion hurdles. Separately, the analyst said he wouldn't be surprised to see OraSure (OSUR) also attempt to develop a Zika test given the company's response to Ebola last year, though as with NewLink, Criscuolo believes any such effort would be peripheral to OraSure's primary businesses. OTHERS TO WATCH: Other publicly traded companies involved in combating Zika include Inovio (INO) and Cerus (CERS). PRICE ACTION: Shares of NewLink are up roughly 5% to $25.63. Meanwhile, Intrexon has slipped 5.5% on Tuesday afternoon but is still up 15% over the last five trading days. Among others with links to Zika, OraSure is up fractionally, Inovio has fallen 7% and Cerus has dipped 1.4% this afternoon.

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