A Simple, Powerful Concept.

The capacity of our immune system to respond to and eliminate pathogenic organisms such as bacteria is due to the presence of lymphocytes that express cell surface antibody receptors that specifically bind the invading pathogen. Upon binding the pathogen these lymphocytes are stimulated to proliferate, increasing the number of pathogen-specific lymphocytes and differentiate into cells we term Antibody Secreting Cells (“ASCs”).
ASCs synthesize and secrete into the blood stream and tissues large amounts of pathogen-specific antibody with capacity to eliminate the pathogenic organism. ASCs continue to be produced for as long as the pathogen is present and cease to be produced once the pathogen is eliminated, transiently enter the blood stream and then migrate to secondary lymphoid organs such as lymph nodes and bone marrow where they may persist and continue to produce antibody for long periods. The appearance of pathogen-specific ASCs in the blood is the earliest indication of the presence of a pathogen (see figure).

The disappearance of pathogen-specific ASCs from blood circulation is a definitive indication that the pathogen is no longer present, i.e., the infection has been resolved. Importantly, unlike pathogen-specific blood antibodies that are detectable for long periods, i.e., years in many cases, after elimination of the infecting pathogen, the presence of pathogen-specific blood ASCs distinguishes a current active infection from a prior infection with the same pathogen as illustrated in the accompanying figure.

MicroBplex’s approach to diagnostics for infectious diseases is to detect the presence in blood of ASCs that synthesize antibodies that bind the pathogen thought to be responsible for the infection. We accomplish this by isolating ASCs from patient blood, culturing the ASCs in a novel, patent pending media, Media Enriched for Newly Synthesized Antibody (MENSA), and measuring the amount of pathogen-specific antibody produced by the cultured ASCs. In addition to measuring the amount of pathogen-specific antibody we also determine the specificity of antibody produced by ASCs as an indication of immune protection, i.e., presence of neutralizing antibodies, against the infecting pathogen. Our approach has significant advantages versus other diagnostic methods including:

  1. Earlier results,
  2. Identifies presence/absence of immune protection,
  3. Provides indication of therapeutic effectiveness,
  4. Does not require presence of the pathogenic organism,
  5. Results obtained with a single whole blood sample and not invasive deep tissue biopsy sample(s),
  6. Not vulnerable to sampling error (wrong site or contamination by skin flora); and
  7. Not confounded by the patient’s prior immune history.

There are now substantial reports in the scientific literature that support the detection of ASCs for diagnosing infection. These include: Streptococcus pneumonia (lung infection); Respiratory Syncitial Virus (RSV, lung infection); Staphylococcus aureus (orthopaedic infections), Staphylococcus epidermidis (orthopaedic infections); Clostridium difficile (gastrointestinal infection), and Borrelia burgdorferi (Lyme disease). Additionally, federal agencies are investing in MicroBplex’ approach as indicated by federal grants awarded in a highly competitive peer review process. MicroBplex was awarded Phase I and II SBIR grant from the CDC to create a new method for identifying patients at risk for recurrent Clostridium difficile infections (see PRODUCT PIPELINE), and our Scientific Founders have received NIH grants to measure the ASC response to Streptococcus pneumoniae infections (Dr. Lee) and to explore the utility of measuring ASCs for the detection of deep-seated Staphylococcus aureus infections in patients with orthopaedic implants (Dr. Daiss).


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