Navigation Links
RPS Announces FDA Clearance of Rapid, Point-of-Care Test for Dry Eye Disease – InflammaDry®
Date:11/25/2013

Sarasota, Fl (PRWEB) November 25, 2013

Rapid Pathogen Screening, Inc. (RPS®) today announced that the U.S. Food and Drug Administration (FDA) has cleared InflammaDry® – a rapid, disposable, in-office test to aid in the diagnosis of dry eye disease – for sale in the United States.

Dry eye is a multifactorial disease that often leads to inflammation and results in discomfort, visual disturbance, and tear film instability, with potential damage to the ocular surface. It is estimated that more than 30 million people suffer from dry eye in the United States. Factors contributing to dry eye disease include age, environment, medical conditions, and hormonal changes, among others. Accurate diagnosis of dry eye is especially critical before ocular surgery is performed. Clinical studies by Fournié and Mutoh have demonstrated that diagnosis and treatment of dry eye disease prior to refractive surgery has resulted in improved healing and reduced complications.

InflammaDry is the first and only, rapid, in-office test to detect matrix metalloproteinase 9 (MMP-9), a clinically relevant inflammatory marker that is consistently elevated in the tears of patients with dry eye disease. The test plays an essential role in accurately diagnosing dry eye disease, as clinical signs of the condition resemble other eye ailments and are not always directly related to patient complaints.

“FDA’s clearance of the InflammaDry test is another important milestone for RPS,” said Robert Sambursky, MD, chief executive officer, president, and chairman of RPS. “InflammaDry will help clinicians confirm the diagnosis of dry eye before the patient leaves their office, resulting in more timely and appropriate management of their disease.”

InflammaDry is an affordable, single-use test that requires no additional equipment to administer or interpret results. Using only a small sample of human tears, the simple, four-step InflammaDry process takes less than two minutes to complete and can be performed by a technician during a patient’s initial workup. Results are available for the clinician in just ten minutes, allowing a treatment plan to be established with the patient during their initial office visit. Similar to the company’s other diagnostic test, AdenoPlus®, the test displays a blue control line for a negative result, or blue and red lines for a positive result.

Providers should not face reimbursement or coding obstacles when using this test. According to Eric Donnenfeld, MD, FAAO, president of the American Society of Cataract and Refractive Surgery (ASCRS), “providers should bill CPT code 83516, immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method, for the InflammaDry test.” Medicare payment for this code is currently $15.86. “The ability to report a CPT code and receive a reasonable payment for this test will help to facilitate patient access,” said Donnenfeld.

“Of course, providers should always follow specific payer guidelines and contact the specific payer if they have any questions regarding billing or payment,” said Sambursky. “Reimbursement is dynamic and new codes and changes are implemented annually.”

The 510(k) clearance allows the InflammaDry test to be used in physician offices that are certified to perform moderately complex tests under the Centers for Medicare and Medicaid Services’ Clinical Laboratory Improvement Amendments (CLIA). The InflammaDry test will also be submitted to FDA for CLIA waiver review. If granted, a waived status would allow the test to be used in any CLIA-waived physician office. For more information, visit http://www.InflammaDry.com. To pre-order the InflammaDry test, email info(at)InflammaDry(dot)com or call 941.556.1850.

About RPS
Founded in 2004, Rapid Pathogen Screening, Inc. (RPS®) is an emerging developer, manufacturer, and marketer of rapid point-of-care (POC) diagnostic tests. The company’s innovative and patented technology platform facilitates the development of a spectrum of cost-effective tests to support the rapid diagnosis of patients with infectious diseases and inflammatory conditions. As a result of U.S. government contracts, this platform is also being developed to help detect the body’s immune response to viral and bacterial infections as well as chemical nerve agent blood toxins. RPS tests have high sensitivity and specificity, and can be easily performed by a clinician or their staff without extensive training or additional equipment. For more information on RPS or its products, visit RPSdetectors.com.

# # #

For additional information, contact:
Laura Lovejoy, 941.928.9025, laura(at)saranova(dot)net

Read the full story at http://www.prweb.com/releases/2013/11/prweb11365969.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Goodmark Medical announces joining the American Chiropractic Association’s (ACA) Corporate Member Program
2. ISPE Announces Recipients of 2013 International Honor Awards at Global Annual Meeting
3. Ceres Announces Fiscal Year 2013 Financial Results
4. National Association of Professional Women Announces Michelle Doss, Director, Fujifilm Diosynth Biotechnology, as VIP Woman of the Year
5. Telomere Biosciences Announces: TELO-100 with T-Activator 150, a Breakthrough in Telomere Science and Age Management
6. Soligenix Announces Initial $600,000 Investment and up to $10.6 Million Common Stock Purchase Agreement with Lincoln Park Capital Fund, LLC
7. Sequenom Announces Participation At The Piper Jaffray 25th Annual Health Care Conference
8. Aratana Therapeutics Announces Positive Top-Line Results from AT-001 Dose-Ranging Field Study in Client-Owned Dogs with Osteoarthritis
9. Sangamo BioSciences Announces Seven Data Presentations At The 2013 American Society of Hematology Annual Meeting
10. Jazz Pharmaceuticals Announces Participation at the Piper Jaffray Healthcare Conference on December 3
11. Northwest Biotherapeutics Announces Pricing Of Public Offering Of Common Stock And Warrants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... ... December 09, 2016 , ... Horses Helping Horses' donation level ... charity, it not only donates 15%-20% of each sale to Brooke USA , ... factory-permitted prices. , At inception, over 50 brands comprising over 2,700 items are represented, ...
(Date:12/9/2016)... , ... December 09, 2016 , ... There’s a winning ... 2016 by the Orange County Register, after winning the award last year as well. ... sought-after employer. President and COO Daniel Vesely pointed to the tech company’s upbeat environment ...
(Date:12/9/2016)... NEW YORK (PRWEB) , ... December 09, 2016 , ... ... have been honored with the Breakthrough Solution of the Year Award from Platts ... dicarboxylic methyl ester (FDME). The award was announced at the 18th Platts Global ...
(Date:12/9/2016)... ... ... Aditya Humad, Acting CFO of AxioMed and Managing Partner of KICVentures, is pleased ... now gaining interest from Silicon Valley. “It was satisfying to complete the due diligence ... that, “We expect interest to continue to rise as AxioMed completes its cleanroom assembly ...
Breaking Biology Technology:
(Date:12/8/2016)... Research Future published a half cooked research report on Mobile Biometric ... Market is expected to grow over the CAGR of ~35% during ... ... Mobile Biometric Security and Service Market is increasing at a ... security from unwanted cyber threats. The increasing use of mobile device ...
(Date:12/8/2016)...  Singulex, Inc., the leader in Next Generation Immunodiagnostics ... license and supply agreement with Thermo Fisher Scientific, the ... access to Thermo Scientific BRAHMS PCT (Procalcitonin), a biomarker ... to diagnose systemic bacterial infection and sepsis and in ... in assessing the risk of critically ill patients for ...
(Date:12/7/2016)... -- According to a new market research report "Emotion Detection and ... Recognition), Service, Application Area, End User, And Region - Global Forecast to 2021", ... Billion in 2016 to USD 36.07 Billion by 2021, at a Compound Annual ... ... MarketsandMarkets Logo ...
Breaking Biology News(10 mins):