Point-of-Care Test aids diagnosis of acute conjunctivitis.
October 29, 2012 -
FDA-cleared and CLIA-waived AdenoPlus™ accurately detects adenovirus, which accounts for up to 90% of all viral conjunctivitis and ~1 of 4 cases of acute conjunctivitis seen by eyecare practitioners. As part of Red Eye Protocol, this solution can offer eyecare professionals efficient and effective method to diagnose cause of disease. Test has 90% sensitivity and 96% specificity. Its 4-step process takes less than 2 min to complete and provides definite result in 10 min.
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
|Original Press Release |
Bt HB4, 1681 route des Dolines, BP313, 06906 Sophia Antipolis cedex
Nicox Launches AdenoPlus(TM) in the United States
• Innovative device for differential diagnosis of acute conjunctivitis is Nicox's first commercial launch
• New visual identity unveiled to present Nicox as a specialty ophthalmic group
Sophia Antipolis, France.
Nicox S.A. (NYSE Euronext Paris: COX) today announces its United States (US) launch of AdenoPlus(TM), the first and only FDA-cleared, CLIA-waived(1), rapid point-of-care diagnostic test that aids in the differential diagnosis of acute conjunctivitis. AdenoPlus(TM) is Nicox's first product launch since it announced its strategy of becoming an international, late-stage development and commercial ophthalmic business, reflected by a new visual identity also unveiled today.
Michele Garufi, Chairman and CEO of Nicox, commented: "With AdenoPlus(TM) Nicox has taken a first step towards fulfilling its objective of starting a commercial business in the ophthalmic space. We have established a specialized sales team on the ground who will be marketing and selling this innovative and easy-to-use product to eyecare practitioners across the US, bringing a new, fast and accurate diagnostic option that will aid in the differential diagnosis of acute conjunctivitis.
The entire management team is working tirelessly to secure additional ophthalmic assets to build a comprehensive portfolio of diagnostics, therapeutics and medical devices. With Bausch + Lomb's positive results observed in phase 2b with our glaucoma candidate earlier this year, solid internal RD expertise and a growing network in the eyecare field, I believe we are in a strong position to grow rapidly as a specialist ophthalmic business."
AdenoPlus(TM) can rapidly aid in the differential diagnosis of acute conjunctivitis
AdenoPlus(TM) accurately detects adenovirus, which accounts for up to 90% of all viral conjunctivitis, and approximately one out of four cases of acute conjunctivitis seen by eyecare practitioners(2). As part of a "Red Eye Protocol", AdenoPlus(TM) can offer eyecare professionals an efficient and effective method to diagnose the cause of the disease. The test, which has 90% sensitivity and 96% specificity, is fast and easy-to-use. The simple, four-step process takes less than two minutes to complete and provides a definite result in just ten minutes. An accurate diagnosis enables clinicians to make better therapeutic decisions based on diagnostic evidence and allows patients to leave the clinician's office better informed and better prepared, knowing if their red eye is adenovirus and whether they can return to work. For more information on AdenoPlus(TM), please call 1.855.MY.NICOX (from the US).
Acute Conjunctivitis is often misdiagnosed due to the overlapping presentation of signs and symptoms among the major subtypes
It has been estimated that at least 6 million cases of acute conjunctivitis are diagnosed in the US each year(3) and studies indicate that eyecare professionals make an accurate clinical diagnosis approximately 50% of the time(2). This is because viral, bacterial, and allergic conjunctivitis - the most common types - manifest similarly, making differential diagnosis using only signs and symptoms challenging. Misdiagnosis represents a major problem, as adenovirus is highly contagious and associated with significant morbidity, including decreased visual acuity, light sensitivity, chronic excessive tear production, visual loss and presence of subepithelial infiltrates. The majority of acute conjunctivitis cases result in a prescription for antibiotics, even in viral cases when antibiotics are not necessary. Inappropriate antibiotic use may increase adverse effects, promote resistance and add avoidable costs to the healthcare system.
Jerry St. Peter, Executive Vice President and General Manager of Nicox Inc., said: "Our first commercial launch is poised to transform the way eyecare practitioners diagnose, and subsequently manage, acute conjunctivitis. AdenoPlus(TM) is accurate, fast, cost-effective, and performed at the point of care, making it a valuable test in seeking an immediate and accurate diagnosis. As a product, AdenoPlus(TM) is an embodiment of our ongoing mission: to bring effective, efficient, and evidence-based solutions to the ophthalmic market."
New visual identity unveiled today
Nicox has also today unveiled a new brand identity that represents its new positioning as an international late-stage development and commercial ophthalmic group. The new logo, together with the tagline 'Visible Science', underlines the Company's strong R&D heritage now leveraged in the ophthalmic field.
Nicox to attend AAOpt and AAO annual meetings
Nicox will attend the American Academy of Ophthalmology (AAO) & Asia Pacific Academy of Ophthalmology (APAO) 2012 Joint Meeting, taking place from November 10 to 13 in Chicago, Illinois (booth 2735). Nicox will also be present at the 91st Annual Meeting of the American Academy of Optometry (AAOpt) from October 24 to 27, 2012, in Phoenix, Arizona (booth 517).
Worldwide licensing agreement between Nicox and RPSŪ
AdenoPlus(TM) was in-licensed from Rapid Pathogen Screening, Inc (RPSŪ) in June 2012, together with other ocular diagnostic tests currently in development. The worldwide licensing agreement grants Nicox exclusive rights to commercialize AdenoPlus(TM) to eyecare professionals in the US, as well as full exclusive rights to market AdenoPlus(TM) in the rest of the world. RPSŪ maintains rights to commercialize these ocular tests to primary and urgent care professionals in the US.
Following the completion of the worldwide licensing agreement, Nicox has built up its sales infrastructure in the US. During this period, RPSŪ has taken AdenoPlus(TM) orders for Nicox. Nicox's sales team is now actively starting the direct marketing of AdenoPlus(TM) to targeted eyecare practitioners in the US. The launch of AdenoPlus(TM) represents an important first step in the Company's new strategy but will not take Nicox to profitability on its own. Nicox plans to exploit its new sales infrastructure to market other ophthalmic products in the future.
AdenoPlus(TM) is CE-marked and is available for sale by Nicox or its distributors in Europe and other countries. Nicox is focused on strategic efforts to secure AdenoPlus(TM) reimbursement throughout Europe.
(1) The Clinical Laboratory Improvement Amendments (CLIA) establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A waiver signifies that the test has been classified as a low complexity device, which allows medical office personnel of CLIA-waived offices (not only physicians) to perform it.
(2) O'Brien TP, Jeng BH, McDonald M, et al. Acute conjunctivitis: truth and misconceptions. Curr Med Res Opin. 2009 Aug; 25(8):1953-61.
(3) 2005 Thomson Healthcare Medstat
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating an international, late-stage development and commercial ophthalmic group based around therapeutics, diagnostics and devices.
Nicox has inlicensed innovative ocular diagnostics from RPSŪ, including AdenoPlus(TM), a test for the detection of adenoviral conjunctivitis already authorized for marketing in the United States and Europe. The Company has a partnership with Bausch + Lomb for the development of BOL303259X, a novel glaucoma candidate based on Nicox's proprietary nitric oxide-donating R&D platform.
Further nitric oxide-donating compounds are under development in non-ophthalmic indications notably through partners, including Merck (known as MSD outside the United States and Canada) and Ferrer.
Nicox S.A. is headquartered in France and is listed on Euronext Paris (Compartment C: Small Caps). For more information please visit www.nicox.com.
United States Robert Stanislaro | D +1 (212) 850 5657 | M +1 (917) 968 9795
Irma Gomez-Dib | D +1 (212) 850 5761 | M +1 (415) 706 9155
AdenoPlus(TM) enquiries Pascale Communications
Mike Elofer | +1 484 620 6167 | firstname.lastname@example.org