Bridging the GAP

RPS’s novel point-of-care tests BRIDGE THE GAP between current clinical practice and the standard of care, helping physicians provide the BEST POSSIBLE

PATIENT MANAGEMENT while acting as good stewards of therapeutic resources.

university medical centers, and global industry leaders. RPS will leverage these relationships to drive broad global acceptance of its tests, helping to bridge the gap between current clinical practice and the standard of care.

TechnologyThe company’s innovative and patented technology platforms include Direct Sampling Micro-Filtration (DSMF) and Direct Multi-Planar Chromafiltography (DMC) technologies. DSMF

represents RPS’s core technology advantage in applying a patient sample directly to the test strip without extraction and

subsequent dilution of the sample. The DMC technology leverages these core advantages and

simultaneously enhances the sensitivity of RPS tests compared to competitive POC tests.

RPS’s versatile technology platforms allow the company to develop POC tests that detect both large and small peptides, protein or nucleic acid target analytes, and that identify specific pathogens or inflammatory biomarkers in a variety of different sample matrices. RPS also continues to research and evaluate technological advances – including a promising new molecular-based POC nucleic acid platform – to further develop and strengthen its current and future product portfolio.

RPS strives to develop tests that address critical POC diagnostic requirements:

Test results in less than 15 minutes after sample collection

No sample preparation, just a simple sample collection and transfer step

Sensitivity substantially equivalent to laboratory-based gold standards

Multiplex capability without matrix limitations

CLIA-waived and easily performed by any healthcare professional

Low cost and reimbursable

RPS’s innovative and patented technology platforms facilitate the development

of a spectrum of cost-effective tests to support the rapid diagnosis of patients

with infectious diseases and inflammatory conditions.

TODAYDifferentiating many diseases using clinical symptoms and signs alone is challenging. Although clinical presentation can be similar, patient management and treatment plans vary for different diseases. POC testing allows a rapid and accurate test to be performed while the patient remains in the initial healthcare setting. Receiving prompt test results supports the clinician’s informed decision and appropriate treatment plan, helping to reduce the spread of disease, limit inappropriate treatments, and decrease healthcare costs.

RPS’s innovative and patented technology platforms facilitate 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, RPS is also developing tests to help detect the body’s immune response to viral and bacterial infections as well as chemical nerve agent blood poisoning. Unlike other companies in the rapidly growing POC industry, the combination of RPS’s strong intellectual property (IP) and unique technology platforms facilitates the development of unique and easy-to-use tests that target critical and unmet healthcare needs in the diagnostic marketplace.

RPS tests have high sensitivity and specificity, and can be easily performed by a clinician or their staff without extensive training or ancillary equipment. Additionally, the company has more than 30 issued or licensed patents, demonstrating its robust IP portfolio. With these benefits, technological advances, and strong IP, RPS tests will continue to increasingly and positively impact global healthcare.

RPS has proven the capability to commercialize POC tests that utilize its proprietary and versatile technology platforms through the regulatory approval and worldwide market launch of its existing diagnostic tests. The company is also unique in its established relationships and collaborative agreements with U.S. government agencies, prominent U.S.

TestsRPS is strategically focused on designing, developing, and delivering novel POC tests for ocular and systemic infectious diseases, inflammatory conditions, and chemical nerve agent blood poisoning. RPS tests target three distinct channels: primary/urgent care, eye care professionals, and government. Currently available tests include AdenoPlus to aid in the diagnosis of Adenoviral conjunctivitis (pink eye) and InflammaDry to aid in the diagnosis of dry eye disease. These disposable, single-use tests lead to a more accurate diagnosis during the initial clinical exam, which allows for better patient management and therapeutic decision-making.

A second-generation version of RPS’s initial product, AdenoPlus is the first and only CLIA-waived, CE-marked, POC test to aid in the detection of Adenoviral conjunctivitis. Acute infec-tious conjunctivitis can be caused by a virus or bacteria. There is a significant amount of overlap in the symptoms and signs of these infections. Due to this overlap, many healthcare providers empirically treat all conjunctivitis patents with topical antibiotics, which are ineffective against the viral form of the infection. This causes many patients to return to school, work, or daycare while still highly contagious. Using a small tear sample, this 10-minute disposable test allows for the rapid, in-office detection of Adenoviral antigens directly from human tears collected from the inside of the lower eyelid.

AdenoPlus has greater analytical sensitivity than the first generation test and demonstrates a clinical sensitivity of 90% and a specificity of 96% when compared against cell culture – the gold standard – as the reference method. The AdenoPlus test is available worldwide and is reimbursable in the U.S. using CPT code 87809QW.

InflammaDry is the first and only rapid, POC test to help detect elevated levels of matrix metallo-proteinase 9 (MMP-9), an inflamma-tory marker elevated in the tears of patients with dry eye disease. The clinical signs of dry eye often do not correlate with patient complaints, making this disease difficult to diagnose. Additionally, inflammation associated with dry eye disease may precede the appear-ance of clinical signs. The InflammaDry test demonstrates 81% positive agreement/sensitivity and 98% negative agreement/specificity.* Additionally, the InflammaDry test demonstrates a positive predictive value (PPV) of 98% and negative predictive value (NPV) of 83%.

The InflammaDry test can be performed on patients that present with symptoms and signs of dry eye or as part of a pre-operative dry eye work-up on patients planning to undergo cataract or refractive surgery. Studies show that these patients may benefit from the initiation of targeted perioperative therapy to optimize the ocular surface, which may help to achieve better surgical and general patient outcomes. The InflammaDry test is CLIA-waived, CE-marked and available worldwide. In the U.S., the InflammaDry test is reimbursable using CPT code 83516QW.

*The multicenter clinical study demonstrated the following range of performance: positive agreement 66%-97% and negative agreement 97%-98%. At 2 sites, negative agreement could not be calculated because there were no subjects without dry eye.

TOMORROWRPS is working to expand its family of diagnostic solutions for ocular diseases and conditions to include a test for the combined detection of Adenoviral and allergic conjunctivitis as well as a test to diagnose ocular herpes.

The RPS diagnostic platform is also being developed to help detect systemic diseases and conditions, including the body’s immune response to viral and bacterial infections. Globally, systemic diseases are associated with significant morbidity or mortality and are major public health risks. Many systemic diseases and conditions are not self-limiting, have clinical diagnostic un-certainty, and are frequently misdiagnosed; but have ex-isting and effective patient management plans.

Febrile respiratory illnesses, typically caused by a viral and/or bacterial infection, are highly contagious, and due to a significant overlap in symptoms or signs, are often difficult to clinically differentiate. Sexually transmitted infections are caused by numerous different pathogens that present with similar clinical symptoms and signs and lead to significant morbidity and economic burden. The diagnostic ambiguity of these and other systemic infections leads to the over prescription of antibiotics and fosters antibiotic resistance and increased costs, thereby increasing the need for accurate diagnostic

tests. Obtaining a rapid and accurate diagnosis identifies contagious patients to reduce the spread of disease, provides the basis for targeted therapeutic interventions for improvement or cure, and reduces the use of unnecessary treatments.

RPS is honored to be the recipient of a contract award from the U.S. Department of Homeland Security to develop and

manufacture a rapid and accurate diagnostic test for febrile respiratory illness. Using a fingerstick blood sample, this test will help to confirm the presence of a clinically significant immune response to a viral and/or bacterial infection.

Additionally, based on a U.S. Defense Threat Reduction Agency-funded effort to increase U.S. preparedness, RPS is exploring diagnostic capabilities to aid in the

detection of chemical nerve agent blood poisoning in humans.

Leveraging opportunities outside of its core immunoassay business, RPS will seek to out-license exclusive rights that it has obtained to novel reagents and therapeutics. This robust pipeline will facilitate the company’s continued impact on global healthcare by helping

to bridge the gap between current clinical practice and the standard of care.

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