Techlab, Inc.

Other

Virginia Tech Intellectual Properties, Inc.

Research, Incorporated

Oravax, Inc.

Intercell Usa, Inc.

David Maxwell Lyerly

Tracy Dale Wilkins

James Hunter Boone

Richard Littleton Guerrant

Carol J Phelps

Robert J Carman

Limin Zheng

J Scott Moncrief

Manli Y Davis

Kristen Schwab

Jodie Stevens

Li Chen

Thomas P Monath

James Scott Moncrief

Zhenxi Zhang

Wende Lei

William D Thomas

Krista A Williams

Janice E Buss

Francisco Javier Torres-Lopez

Jocelyn N Browning

James H Boone

James Boone

Tracy D Wilkins

Carol Phelps

disease involves a range of clinical presentations ranging from carrier status with other causes of symptoms to mild and self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases ofare treated differently depending on the presence and then the severity of disease. Patients that are carriers may not receive treatment with concern of causing the disease. Mild to moderate cases may be treated with metronidazole while severe and relapsing cases are often treated with vancomycin or fidaxomicin. Current molecular assays are highly sensitive for detecting toxigenicand cannot rule out carrier status. Utilization of a biomarker panel that includesantigen (GDH), toxins A and B, and fecal lactoferrin allows clinicians to differentiate between a carrier state and active state ofand allows for monitoring to evaluate the effectiveness of treatment.

Clostridium difficile dehydrogenase and toxin as a biomarker for monitoring infection in patients with clostridium difficile disease and differentiating carrier state from active disease

disease involves a range of clinical presentations ranging from mild to self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases ofare treated differently depending on severity of disease. Mild and moderate cases may be treated with metronidazole while moderate-to-severe and relapsing cases are often treated with vancomycin or fidaxomicin. The presence ofdisease is detected using a biomarker panel that includesantigen (GDH), toxins A and B, and fecal lactoferrin. In patients suspected ofdisease, if GDH is detected indicating the presence of, and then toxins A and/or B are detected to indicate toxigenicand support a diagnosis of-associated disease, fecal lactoferrin concentrations are measured to determine severity of the disease by indicating the amount of intestinal inflammation.

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Nucleic acid amplification tests have been widely used in clinical laboratories. Nucleic acid extraction from biological materials is challenging because different unfavorable substances may co-extract and inhibit downstream applications. The present invention relates to a composition of and a method for treating the sample prior, during or post extraction of nucleic acid. More specifically, the claimed invention relates to a composition of and a method for using low concentrations of common organic solvents to remove inhibitors of nucleic acid amplification. The present invention can be used for extracting nucleic acids (DNA/RNA) from bacteria, viruses, parasites, and other biological materials or matrices, including but not limit to, stool samples, body fluids, plants and cultures. The method is rapid, low-cost, and easy to use in a laboratory setting. The nucleic acid extracted in accordance with the invention can be used for nucleic acid amplification reactions.

Nucleic acid extraction using organic solvents to remove inhibitors

Accurate and fast detection of the presence ofdisease is important for the proper treatment of patients withinfection. Present tests depend upon culture of viable bacteria and identification by microscopy, which requires care, skill, and two or more days for conclusive results. The current invention improves the ease of use and overcomes the limitations of loss of viability and delay inherent inbacterial culture and provides a more rapid alternative for the identification and diagnosis ofand campylobacteriosis. The invention provides a new method of detectingby utilizing an outer membrane protein (OMP 18) to develop antibodies for use in immunoassays of bacterial cultures or human fecal samples.

Outer membrane protein 18 as a diagnostic marker for campylobacter

The present invention provides assays and devices for detection of substances in liquid samples. The assays and devices utilize passive diffusion between a porous material and a porous membrane containing a specific binding pair member to enable detection of the substance of interest.

Device and method for detection of analytes

Accurate and rapid differentiation of the outbreak strain ribotype 027 from other possible() strains, using stool samples, facilitates decision making for treatment options. Cell wall protein V (CwpV) contains a cell wall binding domain conserved amongstrains and a variable domain which is antigenically different amongstrains. In embodiments, antibodies against the 027-specific region in CwpV are used in diagnostic tests to detect ribotype 027 in culture or fecal samples.

Accurate and fast detection of the presence of() disease is crucial for the proper treatment of patients withinfection. Present tests detecting the presence ofdisease are fast and cost effective, but are not very sensitive. Using an ELISA including Cell Wall Protein 84 (Cwp84) increases the sensitivity of the ELISA. Cwp84 may be used alone or in combination with other markers to support a diagnosis of-associated disease.

A method for aiding in differentiating irritable bowel syndrome from inflammatory bowel disease by determining the level of total endogenous human lactoferrin in clinical specimens, such as feces, mucus and bile, wherein an elevated level of lactoferrin substantially precludes diagnoses of IBS and other noninflammatory etiologies, and a kit usable in such method are provided. Further provided is a method for quantitating the level of total endogenous human lactoferrin in clinical specimens, such as feces, mucus and bile, to monitor gastrointestinal inflammation in persons having inflammatory bowel disease.

Method for diagnosing irritable bowel syndrome and monitoring inflammatory bowel disease

A method for the differentiation of inflammatory bowel disease (IBD) from irritable bowel disease (IBS) followed by distinguishing ulcerative colitis and Crohn's disease from other gastrointestinal illnesses. This highly differential method first uses the presence of elevated lactoferrin as a marker of intestinal inflammation to differentiate IBD from IBS. Patients suspected of IBD are then analyzed for fecal anti-antibodies (ASCA) as an indicator of Crohn's disease and fecal anti-neutrophil cytoplasmic antibodies (ANCA) as an indicator of ulcerative colitis. IBD patients are further monitored for intestinal inflammation using fecal lactoferrin to evaluate the effectiveness of medical therapy and to predict relapse. The apparatus comprises either a qualitative enzyme-linked immunoassay or other immunoassay that utilizes antibodies specific to human immunoglobins for the measurement of total endogenous lactoferrin, ASCA and ANCA in human feces. The method and apparatus can be used by healthcare providers to identify IBD and distinguish ulcerative colitis from Crohn's disease.

Inflammatory bowel disease and irritable bowel syndrome IBD-first chek diagnostic panel

A method and apparatus for the differentiation of ulcerative colitis from Crohn's disease and other gastrointestinal illnesses using the presence of anti-neutrophil cytoplasmic antibodies (ANCA) as a marker of ulcerative colitis is described. The apparatus consists of either a qualitative enzyme-linked immunoassay or other immunoassay that utilizes antibodies specific to human immunoglobulins for the measurement of total endogenous ANCA in a human sample. The method and apparatus can be used by healthcare providers to distinguish ulcerative colitis from Crohn's disease and other gastrointestinal illnesses.

Method for distinguishing ulcerative colitis from Crohn's disease by detecting the presence of fecal anit-neutrophil cytoplasmic antibodies (ANCA)

Method for monitoring gastrointestinal inflammation in persons with inflammatory bowel disease(IBD)

Method for differentiating irritable bowel syndrome from inflammatory bowel disease (IBD) and for monitoring persons with IBD using total endogenous lactoferrin as a marker

Growing community of inventors

Radford, VA, United States of America

David Maxwell Lyerly