A three-year-old diagnostic company born from a research agreement between a father-son-son ophthalmologist team and a German biotech company recently received a boost of support from a cost-effectiveness analysis of its flagship product.

Rapid Pathogen Screening (RPS; South Williamsport, Pennsylvania) reported that a new cost effectiveness analysis from the Health Economics Consulting Group (HECG) shows a savings of more than $400 million a year to the healthcare system if the RPS Adeno Detector were used on all 6 million annual cases of acute conjunctivitis, or pink eye.

RPS said its Adeno Detector for detection of viral conjunctivitis is the first in a family of tests and is FDA-cleared. According to the company, the device uses a small sample of tear fluid and provides a definitive result in 10 minutes and essentially makes available an accurate laboratory confirmation of adenoviral conjunctivitis at the time of the patient exam.

"Most folks think of pink eye — or conjunctivitis, its technical term — as one single disease," Dan Maloy, a spokesman for RPS told Medical Device Daily.

But as Maloy explained, about 45% of conjunctivitis cases are viral, about another 45% of cases are bacterial conjunctivitis, and roughly 10% of cases are allergic conjunctivitis.

"The problem is, because most folks just think of it as pink eye or conjunctivitis they don't differentiate between bacterial or viral," Maloy said.

As a result, nearly half of all conjunctivitis cases are misdiagnosed, he said, and close to 90% of the time antibiotics are unnecessarily prescribed as a treatment. That means an added cost for the individual or their insurance company, and it may also increase the patient's risk of antibiotic resistance, Maloy said.

Also, he said, the most common form of viral conjunctivitis — about 80% to 90% of those cases — are adenoviral.

The company says its RPS conjunctivitis detectors make it easy to distinguish viral from bacterial or allergic conjunctivitis.

RPS was found in March 2004 as a joint venture between Sambursky (Binghamton, New York) and Securetec Detektions-Systeme (Munich, Germany). Before the company was formed, Jose Sambursky, MD, and his two sons, Daniel Sambursky, MD, and Robert Sambursky, MD, explored the feasibility of point-of-care detection and identification of infectious diseases in a cooperative research agreement with Securetec. The results led to the formation of RPS.

"Essentially what happened was, on a lake house, our neighbor was involved with a German biotech company, and he worked with rapid diagnostic tests for drugs of abuse and he showed my father the different tests for drugs of abuse," Robert Sambursky, chief medical officer of RPS, told MDD.

That's when the elder Sambursky called Robert and told him he thought the concept could be applied to the medical field.

"I got very excited about it and saw a lot of potential," Robert said.

All three Samburskys are trained clinical ophthalmologists and provide clinical expertise in the diagnosis, management and research of infectious ophthalmologic diseases, the company noted.

While Robert was at Willis Eye Hospital (Philadelphia) completing his residency and Cornea Fellowship, he ran clinical trials which he said produced "very promising" results, so the Samburskys decided to pursue a company.

Jose and Daniel serve as board members for the company but are not involved in the day-to-day operations of it. Robert stayed on as the company's chief medical officer in addition to serving as a full-time clinical ophthalmologist.

The HECG analysis is based on Medstat MarketScan Data from more than 200,000 insured lives. According to the company, costs approach $200 to treat each case of acute conjunctivitis with the bulk of those costs including physician consults, diagnostic tests, and treatments.

The company also said the study confirms a November 2006 report that demonstrated a 115.5% savings in the weighted average costs of treatments for acute conjunctivitis when the physician uses the waived RPS Adeno Detector as opposed to a laboratory test. That study, performed by Global Health Economics Projects (GHEP; Thousand Oaks, California), used the costs of one of the leading outpatient laboratories and the Medicare 2006 Physician Fee Schedule to determine the costs. The GHEP report further establishes the unnecessary costs associated with additional provider visits and antibiotic overuse, the company said.

"With the addition of the HECG study, we have two analyses that substantiate the economic value of using the RPS Adeno Detector routinely on all acute conjunctivitis cases," Sambursky said. "This information further supports our efforts to aid healthcare providers in achieving the most accurate diagnosis, at the most appropriate location, and resulting in the most effective therapies."

According to the company, the RPS Adeno Detector is designed to aid healthcare providers to make an accurate diagnosis, foster patient acceptance of more supportive therapies, identify contagious viral conjunctivitis, and limit spread of disease while simultaneously reducing ocular antibiotic resistance and the cost of unnecessary antibiotics.

Sambursky said the test is being done as an in-office test as opposed to a lab test so that patients do not have to wait two or three weeks for the results.

"The test itself is really rather unique in that it provides a cost-savings to insurance companies, it helps physicians and healthcare professionals provide a more accurate diagnosis . . . I can't think of a reason not to use it," Sambursky said.

Because patients often think, and sometimes insist, that they need antibiotics to treat the disease, Sambursky said a secondary benefit to the test is that the clinician can show them, in cases of viral conjunctivitis, that they are not going to respond to antibiotics.

"It generates patient buy-in to the appropriate treatment options," he said.

Other POC diagnostic tests in the company's product pipeline include a detector of Herpes Simplex Virus, allergies, and Chlamydia Trachomatis.