Assays and Methods for Detecting Mycobacterial Infections

Human tuberculosis (TB), caused by bacterial pathogen Mycobacterium tuberculosis (Mtb) has been the leading cause of death by infectious diseases worldwide. TB is also the leading cause of death among people who are co-infected with HIV. It is important to accurately diagnose patients with TB infection for the physician to treat the patient and prevent the spread of the disease, especially in the point-of-care clinics where patients are seeking diagnosis and receiving treatment. This is important considering the widespread of drug-resistant TB infections. However, in these point-of-care clinics, especially, in countries with limited resources, TB diagnostic tests that are sensitive and specific are not always available due to the large capital investment and operation.

World Health Organization (WHO) has developed and identified four high priority targeted product profiles (TPPs) as a guideline for the industry to follow to develop next generation TB diagnostic tests that best benefit the need for the effort to control and eradicate the TB epidemic. The four high-priority TPPs are TPP1: nonsputum-based test, TPP2: a simple, inexpensive triage test to rule out TB infection, TPP3: sputum-based microscopy replacement test, and TTP4: drug sensitivity test.

The patent is based on a newly discovered novel feature of Mtb called Phase Variation for which a hypothesis has been proposed for its role in pathogenesis. The intention is to use the Mtb phase variation-derived technologies to develop two rapid TB diagnostic tests, a sputum-based test (TPP3) and a non-sputum based test (TPP1). These inexpensive rapid tests, which will have better sensitivity and specificity, will be important to countries with limited resources, but with wide-spread TB as these tests make it possible for these countries to avoid initial investment in purchasing expensive equipment. Details about the discovery of Mtb phase variation, its novel properties, and its potentials in the development of the TB diagnostic tests can be found in the patent.

Based on the published data, reasonable assumptions, and sound calculations, the worldwide market for these two products has been estimated to include 97 million sputum-smear microscopy tests (SSM tests) and 38.5 million non-sputum-based tests with an estimated combined value total between $346 million and $616 million annually.

WO 2,017,156,436 issued 2017-03-10   [MORE INFO]

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