AptaSure™ - MRSA Point-Of-Care Infectious Disease Testing Device Providing Global Health Care Solutions Through Innovative Technologies

The Issue Every year in the United States (U.S.): 5-10% of hospitalized patients will develop a preventable Healthcare Associated Infection (HAI) Approximately 1.7 million HAI’s are acquired in U.S. hospitals each year More than 99,000 deaths will occur as a result of these preventable HAI’s HAI’s correlate to an additional $20 billion of added healthcare costs

Multi-Drug Resistant Organisms (MDRO’s) Microbial drug-resistance is a growing threat to all humans, especially in healthcare settings. Treatment options of MDRO-associated infections are becoming more and more limiting, as the pathogens evolve resistance to most antimicrobial therapies. These limitations may influence antibiotic usage patterns in ways that suppress normal flora and create a favorable environment for development of colonization when exposed to potential MDRO’s (i.e., selective advantage) Increased lengths of hospitalization, attributed costs, and unfortunate mortality have all been directly correlated to the evolution of MDRO’s in healthcare facilities, as well as within the community.

Methicillin Resistant Staph. aureus (MRSA) MRSA was first isolated in the U.S. in 1968 By the early 1990s, MRSA had accounted for 20%-25% of Staphylococcus aureus isolates from hospitalized patients. In 1999, MRSA accounted for >50% of S. aureus isolates from patients in Intensive Care Units (ICU); in 2003, 59.5% of S. aureus isolates in ICU’s were MRSA. Currently, MRSA accounts for over 90% of S. aureus isolates in ICU settings.

86% OF ALL INVASIVE MRSA INFECTIONS ARE HEALTHCARE-ASSOCIATED

MRSA carriers also serve as reservoirs for further transmission as they move through healthcare facilities

Have Symptoms? ISOLATION Until confirmation results are available, the patient is often treated anyway, possibly unnecessarily, with costly isolation and antibiotics averaging $500-$2,257 per day. This “precautionary treatment” exposes the patient to unnecessary antibiotics, which in turn increases the likelihood of secondary complications (i.e. – development of Clostridium difficile, etc.).

Until Results are available…isolation costs add up Hospital expenditure is just one of the negative ramifications of waiting for a diagnosis, the healthcare risk and emotional burden to the patient is greater. Patient’s report that isolation made them feel stigmatized, contaminated, neglected, and distressed. Also, multi-patient isolation area’s pose greater risk for cross contamination, and healthcare workers report less interaction with isolation patients.

Healthcare Professional Opinions… “ If only I could determine if the patient was carrier sooner, I could treat sooner, isolate sooner and prevent further spread of infection.” Day Shift RN, Critical Care Department “I absolutely hate putting a patient in the high risk status. Isolation creates fear in the patient and family members and sometimes it is entirely unnecessary”. Night Shift RN, Emergency Department

The Problem No true Point-of-Care (POC), self-contained, single-use testing system on the market for infectious diseases. POC Definition: Medical testing at or near the site of patient care. These are simple, easy to use diagnostic tests which can be performed at the bedside with results immediately available. POC Example: Glucometer – performed at bedside Time is of the essence in health care.

Current RAPID SCREENING METHODS ARE COSTLY… BUT WORK It has been reported that rapid screening can reduce costs by up to 90%, saving healthcare facilities hundreds of thousands annually. However, currently available rapid screening methods are costly, requiring the purchase of capital equipment including analyzers, PC’s, monitors and scanners and still test results are not available for 5-24 hours. Rapid MRSA screening of surgical patients may decrease MRSA infections, by facilitating appropriate selection of antibiotic agents for preoperative prophylaxis. Current use of Rapid Screening Methods is limited because of cost and equipment

Infectious Disease Gets National Attention from President Obama June 2015, while still President of the USA, B.Obama issued an action plan for improved testing and surveillance Goal #3: “Advance Development and Use of Rapid and Innovative Diagnostic Tests for Identification and Characterization of Resistant Bacteria”

Current Rapid Diagnostic Variables Polymerase Chain Reaction (PCR) - Costly Capital Equipment - Frequent “false positive” results based on detection of “dead” pathogens - PCR testing equipment may only be used by trained/licensed personnel Monocolonal Antibodies (lateral flow, etc.) These tests typically do not perform well in out-of-range temperature environments. Reagents typically must be refrigerated. Discovery time requires animal models, and more than 6 months for development Aptamers (lateral flow, etc.) Aptamers provide the highest level of sensitivity and specificity in detecting target pathogens. Aptamers are shelf-stable, not requiring refrigeration. Discovery time of new Aptamer = <8 weeks

Aptamer vs. Antibody

AptaSure™ Technology Oligo Selection Systematic Evolution of Ligands by Exponential Enrichment = SELEX

AptaSure™ The Only True Infectious Disease POC Testing Device Aptamer target detection technology Lateral flow hybridization and visualization FDA waived No additional equipment needed, no refrigeration needed, no special training needed ~1/3 the cost of other PCR based methods Single use disposable testing system Collection Extraction Hybridization Lateral Flow Results (Pos/Neg)

AptaSure™ - MRSA

AptaSure™ - MRSA 2. Activate 3. Wait 1. Swab 4. Read: Neg. 4. Read: Pos.

Reduce RISK … Reduce Costs Screen all patients at >99% accuracy. Isolate only those patients who truly require isolation Treat sooner, better, and appropriately, reducing complications and decreasing hospital stay Reduce cross-contamination risk, as well as reducing Healthcare Associated Infection Risk Enhance the environment and safety of the healthcare worker and patients by knowing in advance if a patient is infectious Save time, costs, complications…but most importantly SAVE LIVES!

AptaSure™ True Infectious Disease POC Testing

Providing Global Health Care Solutions Through Innovative Technologies