Introducing Multiplo - A Single Test That Gives Multiple Diagnoses in Minutes

Why? To promote a healthier, happier world for today and tomorrow. How? By introducing its newest generation, patent-pending Multiplo™ rapid diagnostic technology platform to global healthcare providers. MedMira’s Multiplo™ product line is the world’s first and only rapid diagnostic tests which can simultaneously detect multiple disease markers in minutes.

The face of healthcare across the globe is changing. More and more emphasis is being directed towards the integration of rapid, simple diagnostic tests into day-to-day healthcare regimes. The utility of such Point-of-Care (POC) rapid tests is becoming increasingly recognized in standard practices and emergency situations. Their true value lies in the fact that today’s rapid diagnostic tests are as accurate as traditional testing methods, and while providing results in minutes, instead of hours or days, can be used in just about any location.

A Canadian leader in biotechnology development and manufacturer of premium rapid diagnostic tests, MedMira’s focus is helping people know…® by bringing quality diagnostic solutions closer to end-users. Laboratory professionals, healthcare providers and individuals are continually faced with overwhelming healthcare epidemics and challenges. Immediate and proper diagnosis of diseases and conditions, at or near the POC, is becoming more and more critical. In bringing these diagnostics closer to the patient, healthcare costs can be reduced and results provided faster, ensuring that appropriate treatment can begin immediately.

Its flagship product, the rapid HIV test, has been clinically-validated and market-proven. MedMira’s rapid HIV tests has achieved the stringent regulatory approvals in major markets of the world including Canada, the United States <Reveal® G3 Rapid HIV-1 Antibody Test>, Asia <MiraWell® Rapid HIV Test>, and the European Union <MiraCare™ Rapid HIV Antibody Test>.

In the global rapid diagnostics market today, tests designed for the POC generally utilize one of two technology platforms; the lateral flow technology or the flow-through technology. MedMira’s rapid tests utilize the rapid, flow-through technology platform.

One Platform, Multiple Applications

Due to the flexibility and efficiency of its market-proven Rapid Flow-Through Technology (MRFT) platform, MedMira is able to quickly develop and market reliable, high-quality tests for just about any disease or condition. MedMira’s quality MRFT technology is like no other in the world. Its stability and simplicity puts it well ahead of the rest of the world’s flow-through technologies.

MedMira’s latest, patent-pending product line, Multiplo™, is the newest generation in rapid diagnostic technology. Based on the MFRT technology platform, the Multiplo™ line is the world’s first and only family of rapid diagnostic tests which can simultaneously detect multiple disease markers in minutes, affording healthcare providers with substantial time and cost savings.

Multiplo™’s multi-analyte detection capability is particularly unique, and can only be achieved with a rapid test technology such as the MFRT. Most other rapid test technologies cannot accommodate multi-analyte detection capabilities. The ready adaptability of the Multiplo™ platform affords MedMira the potential to achieve endless possibilities in multiple disease detection.

At the commencement of the testing procedure, a single drop of whole blood, serum or plasma is applied to the immunoreactive test membrane and allowed to flow vertically through the membrane. A colorimetric agent then is applied to visualize the test result. The presence of any target markers in the blood specimen can be visualized immediately at the end of the testing procedure.

The entire test procedure takes less than 3 minutes to perform, and the results are instant. With Multiplo™, only a single drop of specimen is required and minutes later, healthcare providers and patients can receive multiple answers and can make the right treatment decisions, right away. MedMira’s MRFT technology is the basis for this critical advancement in reliable and easy-to-use POC diagnostics.

One Test, More Answers

Identification of individual market needs is the driver for Multiplo™ product development, and several of its up-and-coming products include:

• Multiplo™ rapid HIV/HCV antibody test – for the rapid simultaneous detection of antibodies to HIV and Hepatitis C;
• Multiplo™ rapid HBV/HIV/HCV antibody test for the rapid simultaneous detection of antibodies to Hepatitis B, HIV and Hepatitis C;
  
• Multiplo™ rapid HIV/HSV antibody test for the rapid simultaneous detection of antibodies to HIV and Herpes Simplex Virus;
• Multiplo™ rapid HIV/TP antibody test for the rapid simultaneous detection of antibodies to HIV and Syphilis;
• Multiplo™ rapid STD panels for the rapid detection of a variety of combinations of common sexually transmitted diseases.

The first in this series, the Multiplo™ rapid HIV/HCV antibody test (Multiplo HIV/HCV), was launched at the XVI International AIDS Conference in Toronto, Canada, in August 2006. A logical choice for MedMira’s first assignment, given its experience in the global HIV market and the growing public health concern related to co-infection with HIV and Hepatitis C (HCV). It has been cited that 33 – 40% of HIV-infected individuals are also infected with HCV. The fact that HIV/HCV co-infection can result in a more rapid progression of liver disease, and some studies indicate that certain HCV genotypes may accelerate the progression of HIV, early identification of HIV/HCV co-infection is critical to identifying the proper course of treatment and overall disease management. For these reasons, MedMira expects the clinical utility of Multiplo HIV/HCV to be tremendous.

Endless Possibilities

In addition to its own product development pipeline, MedMira offers its MRFT technology platform for licensing by researchers, other diagnostic product developers and manufacturers. For those looking for a unique alternative to lateral flow test technology in diagnostic product development, access to MedMira’s clinically-proven and fully-validated MRFT technology provides a distinct opportunity.

Intended to be used as a research tool to aid in the development of rapid diagnostic products designed for the POC, MedMira markets and sells a package which contains all components and reagents necessary to design and prove a “do-it-yourself” MRFT concept.

User benefits to the do-it-yourself MRFT include:

• MedMira provides all necessary reagents and components required to use the MFRT technology platform to detect the presence of a specific disease marker of interest in a specimen;
• The MRFT may be configured so that either antibodies or antigens can be detected in a specimen.
• Using the MRFT in the early product development strategy, will help avoid issues around the lateral flow technology upon commercialization of the product.
• The MRFT platform offers virtually endless expansion possibilities;
• The MRFT platform is a market-ready product with the best technical support;
• The MRFT offers the potential for manufacturing, assembly, packaging and branding options of the product.

Ahead of the Curve – With an End-to-End POC Diagnostic Solution

Given MedMira’s success in developing and marketing its MRFT technology platform, in 2006, MedMira acquired two novel biosensor technologies through its wholly-owned subsidiary, Maple Biosciences. Expected to become the next evolution in diagnostic instruments, these biosensor technologies will displace the currently used, 30-year old enzyme linked immunoassays (EIA), which are conduct routine lab tests in hospitals, laboratories, and clinics around the world. The combination of the MRFT technology and Maple’s biosensor technologies will afford MedMira with a complete end-to-end diagnostic solution for the POC.

Maple’s biosensors are portable diagnostic instruments that can measure specific biological interactions occurring in a patient‘s sample through their ability to convert these interactions into electrical signals, which can then be easily measured. For example, a blood sample from an HIV-infected patient will contain HIV antibodies. When a test chip coated with an HIV-antigen is inserted into the biosensor instrument and the patient sample is applied, HIV antibody/antigen binding will occur. This specific binding is then converted into an electrical signal that can be read by the biosensor instrument at the bedside (or POC).

Today’s commercially-available biosensors for clinical diagnostics lack the high sensitivity necessary for medical applications, and therefore, are not widely used. Maple Biosciences’ patented, cutting-edge biosensor technologies offer label free, rapid, real time, and sensitive analysis of any molecular binding event – an evolutionary breakthrough in the clinical diagnostics industry.

Simultaneous detection of multiple disease markers is a prominent feature of Maple’s biosensors, providing a vast improvement over the capabilities of traditional EIA technologies (Table 1). And the simplicity of the testing procedure is a remarkable advancement – making confirmed diagnosis as easy as 1-2-3:

1. Disposable test chips will be coated with a variety of biological markers (such as antibodies or antigens) that are specific to various diseases.
2. A small volume from a single vial of a patient sample will be applied to the test chip, and then the chip is inserted into the portable biosensor instrument.
3. If any of the target disease markers are present in the patient sample, that marker will bind to its corresponding receptor (coated onto the test chip), resulting in a biological interaction that can be detected by the biosensor.

These few steps will create a very simple and cost-effective means of obtaining extremely accurate test results for multiple diseases in a very short time frame.

Aimed at improving both the delivery of healthcare and the patient experience, Maple’s biosensors will enable highly complex laboratory tests to be performed in minutes, reduce the amount of sample collection, and reduce waiting time for test results, and streamline diagnosis of multiple diseases.

For patients, Maple Biosciences instruments will enable same day test results, faster specimen collection, and will use a smaller amount of specimen to perform the same tests that today require multiple vials of blood.

Of importance to both healthcare providers and individuals, MedMira and Maple Biosciences are aiming to provide solutions for the streamlined diagnosis of multiple conditions and diseases from a single specimen. Beginning with Multiplo™, preliminary testing is complete within 3 minutes. And then results are confirmed with Maple’s biosensor instrument in less than 30 minutes.

The Future of POC Testing

MedMira is developing revolutionary diagnostic solutions to prevent tomorrow’s epidemics and to promote a healthier, happier world for today and tomorrow. The potential applications for its clinically validated and market-proven MRFT technology are endless. With the fastest, accurate POC tests in the world, and the capability to detect multiple analytes instantly, MedMira continues bring to market diagnostic solutions that will enable faster and better diagnostics, with improved patient outcomes at lower costs.

With the commercialization of its biosensor technologies, MedMira will soon be able to provide the clinical diagnostic industry with the most effective end-to-end disease diagnosis solution to date. By remaining at the forefront of the diagnostics industry with such complimentary rapid diagnostic products for multiple analyte detection, MedMira intends to directly impact and improve the delivery of healthcare services and the patient experience worldwide.

For more information, contact info@medmira.com .