About RPS

What does RPS do?

RPS Diagnostics is an emerging developer, manufacturer, and marketer of rapid, point-of-care (POC) diagnostic tests.

Where is RPS located?

RPS’s business offices as well as its biosafety level 2 (BSL-2) laboratory are headquartered in Sarasota, Florida.

What is point-of-care (POC) testing?

POC testing is defined as performing any medical test at or near the location of patient care – in other words, during the office visit or at a field location. Studies show that the use of POC tests results in a reduction in morbidity and mortality and saves billions of healthcare dollars each year.1

Why is RPS unique?

RPS is the proud inventor of a revolutionary, patented Direct Sampling Micro-Filtration (DSMF) and patent-pending Direct Multi-Planar Chromafiltography (DMC) technology. RPS tests have high sensitivity and specificity and provide rapid, easy to read results in 10 minutes. Utilizing RPS diagnostic tools enables clinicians to provide their patients with appropriate and timely treatment during the initial office visit. These rapid tests can reduce the number of future superfluous medical office visits and reduce healthcare costs associated with spread of disease and unnecessary treatments.

What products are currently available?

The FebriDx® test to assess the clinical significance of an acute febrile respiratory infection and aid the differentiation of viral or bacterial etiology is CE marked and is available in Europe as well as other countries that accept the CE mark. At this time, the FebriDx® test has not received FDA clearance and is not commercially available in the U.S.

RPS’s InflammaDry® and AdenoPlus® business was acquired by Quidel Corporation on May 16, 2017. In connection with the acquisition and integration process, please contact Quidel’s Customer Service team by calling 800.874.1517 or at customerservice@quidel.com. To assist Quidel’s Customer Service team, please indicate that you are an RPS customer. Effective on May 16, 2017, billing, invoicing and collections have transitioned to Quidel. Payment for all InflammaDry® and AdenoPlus® transactions should be made to Quidel.

What products are in the RPS pipeline?

RPS’s innovative technology platform provides the foundation for developing tests for a variety of infectious diseases and inflammatory conditions. RPS is designing its pipeline products in compliance with regulatory guidelines aligned with receiving waived status under the U.S. Clinical Laboratory Improvement Amendments (CLIA).

What is the U.S. Clinical Laboratory Improvement Amendments (CLIA)?

In the U.S., the Centers for Medicare and Medicaid Services (CMS) regulate all examination of human specimens (e.g., tissue, blood, urine, etc.) for diagnosis, prevention, or treatment purposes through CLIA. The objective of the CLIA program is to ensure quality laboratory testing, even at the point-of-care.

There are three different levels of complexity: waived, moderate, and complex. Waived tests (like AdenoPlus®) have the lowest level of complexity and can be easily performed by most medical office personnel without extensive training or additional equipment. In the U.S., a CLIA certificate of waiver is required in order to administer and be reimbursed2 for using a CLIA-waived test.

[1] Market data from ESPICOM November 2009 Market Research Report; Titled: POC Diagnostics: players, products & future market prospects.

[2] Reimbursement information provided by RPS is gathered from third party sources and is presented for illustrative purposes only. This information does not constitute legal advice and RPS makes no guarantee with respect to coding, coverage, and payment. Laws, regulations, and payer policies concerning reimbursement are complex and change frequently and providers are responsible for all decisions relating to coding and claims submission.

Providers are responsible for reporting the codes that accurately describe the services, tests, and supplies to individual patients and accurately describing the individual patients’ condition. If providers have questions regarding reimbursement policies and/or payment, they should contact the appropriate payer and follow the payer’s billing guidelines.