Cairn Spirulina Breath Test for Gastroparesis

About Cairn Diagnostics

For many patients and physicians, the pathway to a definitive diagnosis can be complex, slow and frustrating. At Cairn Diagnostics, our mission is to develop tests that eliminate complexity and create a safer, faster and clearer path to diagnosis.

Use of our proprietary and validated analytical methods allows us to create diagnostic tests that are user- and patient-friendly and easy to administer, yet powerful in their ability to deliver a definitive diagnosis.

Cairn GEBT for gastroparesis

Gastroparesis is characterized by delayed gastric emptying in the absence of a mechanical obstruction in the stomach.

While scintigraphy can be used to diagnose gastroparesis, it requires referral to specialized outpatient centers and exposes patients to radiation. As a result, scintigraphy is often used late in the diagnostic pathway, if at all, after other conditions such as dyspepsia, gastroesophageal reflux disease and ulcers are first ruled out.

This challenging pathway can extend the time required to arrive at a definitive diagnosis. Patients are often treated empirically and without confirmation of delayed stomach emptying. Moreover, because symptomology is not highly predictive of gastroparesis, empirical treatment may be unsuccessful, resulting in the patient using disproportionately more health care services and incurring greater health care costs.

The Cairn 13C-Spirulina Gastric Emptying Breath Test (GEBT) is a non-radioactive, non-invasive and easily administered test for measurement of the rate of gastric emptying in adults. Validated against the gold standard reference method of gastric scintigraphy, the Cairn GEBT enables rapid and accurate identification of gastroparesis.

The test can be administered right in the physician’s office and does not require imaging equipment, specialized training or radioactive material. Results are easy to interpret, allowing for diagnosis of gastroparesis without the need for expensive, time-consuming referrals.

Cairn Diagnostics In Brentwood, Tn. on September 17, 2015 Photo by Dean Dixon/AP Images for Feinstein Kean Healthcare

Kerry Bush, President and Chief Operating Officer

Mr. Bush is president and chief operating officer of Cairn Diagnostics. He has extensive experience in hospital and health care administration, clinical laboratory management and combination product (drug and device) startup companies. He was formerly a hospital administrator for Santa Fe Healthcare Systems in Gainesville, Florida and vice president for development and acquisitions at Greater Baltimore Medical Center. He has served as a senior manager and division president in the commercial clinical laboratory business for International Clinical Laboratories, SmithKline Laboratories and National Health Labs. Prior to starting Cairn Diagnostics, Mr. Bush was president and chief operating officer of Meretek Diagnostics, Inc. He holds a bachelor’s degree from the University of Tennessee and master’s degrees in clinical laboratory science and hospital and health care administration from the School of Allied Health Sciences at University of Alabama in Birmingham.

Cairn Diagnostics In Brentwood, Tn. on September 17, 2015 Photo by Dean Dixon/AP Images for Feinstein Kean Healthcare

Stanley Konopka, Ph.D., Clinical Laboratory Director

Dr. Konopka is clinical laboratory director at Cairn Diagnostics. He has served his entire career as medical director of hospital and CLIA-certified reference laboratories, including International Clinical Laboratories, National Health Laboratories and Meretek Diagnostics, Inc. Dr. Konopka earned a doctorate degree in analytical chemistry from State University of New York in Binghamton, NY and completed a postdoctoral fellowship in clinical radiochemistry. Dr. Konopka is certified as a clinical laboratory director by the American Board of Bioanalysts and is licensed as a medical director in the states of Tennessee, Maryland, Rhode Island and New York.

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Catherine Williams, Ph.D., Chief Scientist and Compliance Officer

Dr. Williams is chief scientist at Cairn Diagnostics and leads the company’s product and manufacturing development activities. She is responsible for all regulatory applications to the FDA and for insuring that manufacturing, clinical studies and product development activities are conducted in compliance with the 21 CFR Part 820 (Quality System Regulation) and as required under 21 CFR Parts 210 and 211 (Current Good Manufacturing Practices). Dr. Williams earned a bachelor’s degree in chemistry at the University of Sheffield in the UK and master’s and doctorate degrees in oceanography from the University of Southampton in the UK. She is an expert in stable isotope chemistry. As a postdoctoral fellow she conducted numerous deep-sea explorations investigating stable isotope (including carbon-13) biochemistry of deep-sea organisms.

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Samantha Bouldin, Ph.D., Director, Quality Control and Clinical Testing

Dr. Bouldin is director of quality control and clinical testing at Cairn Diagnostics. Her team is responsible for assaying all raw materials used in manufacturing drug product (GEBT meal), in process materials and finished drug product. She is also a co-director of Cairn’s clinical laboratory. Dr. Bouldin earned a bachelor’s degree in chemistry from Tennessee Technological University, a doctorate in biochemistry at the University of South Carolina and joined Cairn Diagnostics after completing a four-year postdoctoral fellowship in biochemistry with the Department of Pathology, Microbiology and Immunology at Vanderbilt University Medical Center.

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Shane Crabtree, M.S., Director, Analytical Instrumentation

Mr. Crabtree serves as director of analytical instrumentation and as a biostatistician at Cairn Diagnostics. He has extensive experience in installing, operating and validating gas isotope ratio mass spectrometry (GIRMS) systems utilized in Cairn Diagnostics’ clinical laboratory. He is an expert in stable isotope analysis. He is also responsible for calibration and validation of equipment utilized in the quality control unit and in drug manufacturing activities. He was a former engineer with Sercon, Inc. and Europa Scientific, UK, manufacturers of GIRMS systems. Mr. Crabtree earned a degree in physics from Wright State University and a master’s degree in biostatistics from Middle Tennessee State University.

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Tyler Hill, M.S., Director, Drug Manufacturing

Mr. Hill is director of drug manufacturing for Cairn Diagnostics. He is a microbiologist by training and earned a master’s degree in biotechnology from Middle Tennessee State University. He directs all manufacturing activities associated with production of 13C-labeled Spirulina diagnostic substrate at Cairn Diagnostics’ dedicated drug production facility. Mr. Hill oversees manufacturing activities that are conducted consistent with ICH Q7 harmonized guideline (Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients), 21 CFR Parts 210 and 211 (cGMP in Manufacturing Processing, Packaging, or Holding of Drugs and Finished Pharmaceuticals) and 21 CFR Part 4 (cGMP for Combination Products).

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