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The Pipeline | Oct/Nov '13

Rapid Pathogen Screening, Inc.

Rapid Pathogen Screening, Inc., (RPS) is a relatively new company that develops, manufactures, and markets novel, point-of-care diagnostic tests that are performed in a clinician’s office and provide a result during the initial patient visit. The company was founded in 2004 out of a joint venture between a family of ophthalmologists and a German biotechnology company. One of RPS’ cofounders is Robert Sambursky, MD, who serves as its CEO, president, and chairman. Dr. Sambursky is also a practicing ophthalmologist in Sarasota, Florida, specializing in cornea and infectious disease.

rps

RPS’ origins in ophthalmology prompted the company’s first diagnostic tests to target ocular infectious diseases and inflammatory conditions. It takes a couple of seconds to collect a small tear sample and to run these tests that provide results in 10 minutes, much like a pregnancy test. The available tests are disposable with good sensitivity and specificity, and can be easily performed by a clinician or their staff.

The only currently obtainable test in the United States is RPS’ AdenoPlus to detect adenoviral conjunctivitis, which is distributed by Nicox.

As ophthalmologists know, it is quite difficult to differentiate viral conjunctivitis from bacterial conjunctivitis. The effect of an accurate diagnosis in the clinic extends beyond a physician’s individual practice by identifying and isolating contagious patients and preventing the unnecessary use of antibiotics in those with viral infections. A recent study demonstrated that using these types of rapid diagnostic tests could save the US health care system nearly $430 million each year as well as avoid more than 1 million unnecessary antibiotic treatments.1

adenoplus

The AdenoPlus diagnostic test can be administered using four simple steps in less than 2 minutes, and results are visible in just 10 minutes.

Emerging tests on this point-of-care platform include the InflammaDry to detect matrix metalloproteinase 9 (MMP-9), an inflammatory marker that is consistently elevated in the tears of patients with dry eye disease (DED). Clinical signs of dry eye disease are quite variable and complicate the diagnosis, and inflammation is often present in DED patients long before the appearance of clinical signs. Elevated levels of MMP-9 correlate with clinical exam findings, and research shows that MMP-9 may be a more sensitive marker than clinical signs when diagnosing dry eye. In addition, studies show that the diagnosis and treatment of elevated levels of MMP-9 prior to ocular surgery may result in improved wound healing and reduced complications.2,3 The InflammaDry test is CE-marked and Health Canada approved. It is currently under US FDA 510(k) review.

In addition to its ocular tests, RPS is leveraging its platform to develop a robust pipeline of tests for systemic infectious diseases. Its pipeline includes tests to help differentiate a viral from bacterial infection by identifying unique biomarkers in the body’s immune response as well as chemical nerve agent blood toxins. The company has received several US government contracts to facilitate the development of these tests. RPS also works with a strong network of both government and industry partners in its efforts to positively impact global health care while reducing costs.

RPS is a private company funded principally by angel investors. The company recently announced a $6.25 million investment through a convertible note from a strategic investment firm. These funds will be used to accelerate the growth of the RPS product development pipeline and to facilitate the continued commercial availability of its existing products.

1. Udeh B, Schneider J, Ohsfeldt R. Cost effectiveness of a point-of-care test for adenoviral conjunctivitis. Am J Med Sci. 2008;336:254-264.

2. Fournié PR, Gordon GM, Dawson DG, et al. Correlation between epithelial ingrowth and basement membrane remodeling in human corneas after laser-assisted in situ keratomileusis. Arch Ophthalmol. 2010;128(4):426-436.

3. Mutoh T, Nishio M, Matsumoto Y, Arai K. Correlation between the matrix metalloproteinase-9 activity and chondroitin sulfate concentrations in tear fluid after laser in situ keratomileusis. Clin Ophthalmol. 2010;4:823-828.

author
John Berdahl, MD

John Berdahl, MD, is an Assistant Professor of Ophthalmology at the University of South Dakota and in practice at Vance Thompson Vision in Sioux Falls, South Dakota. He may be reached at john.berdahl@vancethompsonvision.com.

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