Oral Fluid Diagnostics – Building a Platform

Our client aims to take a leadership position in advancing access to medical care by becoming the leader in the field of oral fluid diagnostics and developing innovative diagnostic and monitoring tools enabling expansion of testing by healthcare providers. The company has expertise in extensible oral fluid platform technologies for both point-of-care and central laboratory settings. The initial focus will be to build on its early experience and success in developing and manufacturing an oral fluid HIV diagnostic test. The company will then broaden its range of diagnostic products to replace classical blood-based testing and raise the standard of care by targeting the US and European diagnostic markets, the largest in the world.

Industry Background and Opportunity

The $42 billion IVD industry is rapidly evolving, driven by increasing reliance on diagnostic assays for specific diagnosis as well as monitoring and optimizing therapeutic regimens. The emergence of enabling technologies is also causing a significant proportion of diagnostic testing to shift from central labs to both clinical and non-clinical point-of-care settings. Point-of-care testing can be significantly more cost effective than central lab testing and has been shown to be instrumental in expanding healthcare access through testing of underserved populations. While oral fluid has significant advantages over blood for a wide range of conditions in virtually all settings, its application has so far been limited to only a handful of applications – mainly in testing for HIV, genetics and drugs of abuse.

Currently, for example, there is only one company that has a US FDA-approved test based on saliva. (This competitor’s oral fluid tests generated over $70 million of revenues last year, about half of which were from the HIV tests.)

In addition to in-house development, the company will seize opportunities to acquire key products and platform technologies from distressed competitors. the company may also form commercial partnerships either to overcome barriers to market entry or to fund product development.

Strategy – Quick to Market in Phase I

These products have proven market opportunities, low technical development requirements, low regulatory hurdles, can be reliably contract-manufactured in the US, can be brought to market in less than six months, and the company’s team has previously commercialized similar products. These products will quickly establish the company’s commercial viability.

•  BED HIV-1 Incidence EIA Test – Developed by the US Centers for Disease Control and Prevention (CDC) and used in over 35 countries, the test is the primary tool for monitoring the spread of HIV infections around the world. The company is uniquely positioned to become the sole supplier of this test.

•  Oral Fluid Sampling Device – For the collection of oral fluid samples for medical diagnostic testing in high throughput laboratory settings for genetic screening, or pathogen DNA detection.

•  Diagnostic Reagents – The company can synthesize recombinant proteins and antigens de novo for a wide variety of diseases, as well as novel reagents for use by OEM diagnostic developers and manufacturers. The program also provides an opportunistic library of critical analyte-specific reagents, which will eliminate dependency on third party manufacturers of key reagents, ensure a reliable good quality supply of the material and reduce the lead-time for developing a wide range of new infectious disease tests based on the company’s oral fluids test platform.

•  Contract Technical Services – The company has been approached to provide manufacturing support and troubleshooting technical services from an in vitro diagnostic manufacturer outside the USA. The recognized experience of the company’s team can serve as a resource for helping selected developers and manufacturers in their assay development or manufacture on a contract basis, either ongoing or over a fixed time period. It will also provide an early revenue stream.

Building on the Platform in Phase II and III

In Phase II (which will commence within six months of the company’s founding), the company will develop a new strategic rapid oral fluid assay platform, allowing it to compete in the USA and Europe with major diagnostic companies. The assay format has already been vetted using prototype devices and demonstrated performance superior to current FDA-approved tests. Critically, a thorough independent legal review has also been conducted and established that the platform circumvents the suite of patents that have until now been a major barrier to entry for many point-of-care diagnostics manufacturers.

•  Rapid Oral Fluid Assay Platform (First Analyte: HIV) – The first product launched on the new platform will be an oral fluid HIV test for the US market. The test enables painless sampling, is safer than blood HIV tests, can be performed without the assistance of skilled medical staff and is ideal for point-of-care testing due to reasonable cost, long shelf life, and high accuracy.

•  Rapid HIV Incidence Assay – This test is a rapid point-of-care version of the BED HIV-1 Incidence EIA Test (the Phase I product described above). The company’s scientific Team has already developed prototype samples that have shown highly encouraging results and the CDC has expressed a strong desire to see the product commercialized.

Phase III Products

In Phase III, the company will rapidly develop a series of new diagnostic tests based on the platforms developed in previous phases. The company will initially focus on developing oral tests for prominent conditions of public health significance and on establishing a capability to rapidly develop assays in response to the emergence of new infectious diseases. These tests are likely to include, among others, assays for the detection of Hepatitis B surface antigen, Hepatitis C antibody, Lyme Disease antibody, Influenza antibodies (A/B), Syphilis treponemal and non-treponemal antibody, and other sexually transmitted diseases. The company will have a clear competitive edge in responding quickly to new emerging diseases such as seen in the recent past with SARS (Coronavirus), Avian Influenza, Hantavirus and Legionnaire’s Disease (Legionella).

Competitive Advantages

•  The Team -The company’ Scientific Team has been instrumental in the advances made in the field of oral fluid diagnostics to date, contributing to the commercialization of several leading oral fluid diagnostic tools and serving as key players in advancing the science of oral fluid testing.

•  Established Products – The company will implement a three-phase product development strategy and getting to the market quickly with a small range of unique, but established, products for which development has been completed.

•  Internal Capability of Antigen Synthesis – The company can generate its own disease state markers through recombinant protein technology allowing quick response to new markets and changes in market demands such as seen by the sudden emergence of new diseases such as SARS and avian flu.

•  Point-of-Care Oral Fluid Testing Platform – The company has already developed and tested a new oral fluid testing platform on which the company can launch a new Rapid Oral HIV Diagnostic test that will allow it to compete in the highly attractive US and European markets. There is only one competitor in this market and the company’s product has clear competitive advantages, which will change the standard of care in HIV testing.

•  Expertise in Oral Fluid Diagnostics -The company’s Oral Fluid Sampling Device has superior patient appeal, ease and speed of sample collection, sample quality and stability and ease of processing.

•  Extensible Platform Technologies – The company can readily capitalize on its platform technologies by commercializing these into a wide variety of innovative diagnostic products, setting the stage

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