Navigation Links
Cairn Diagnostics Launches FDA-Approved Spirulina Gastric Emptying Breath Test for Gastroparesis
Date:3/29/2016

BRENTWOOD, Tenn., March 29, 2016 /PRNewswire/ -- Cairn Diagnostics, formerly known as Advanced Breath Diagnostics (ABDiagnostics), has launched the 13C-Spirulina Gastric Emptying Breath Test (GEBT). The GEBT is intended for measurements of the rate of solid-phase gastric emptying and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in symptomatic adults. The Cairn GEBT was approved by the U.S. Food and Drug Administration (FDA) on April 6, 2015. The GEBT has been validated against the method of gastric scintigraphy.1

The Cairn GEBT enables the rapid and accurate diagnosis of gastroparesis, is non-radioactive and non-invasive and can be administered conveniently at a physician's office, a laboratory collection center or in a tertiary care setting.

A kit containing the specially labeled test meal and all components necessary to administer the test meal and collect breath samples is provided to the test administration site by Cairn Diagnostics. Collected breath samples are returned to Cairn's CLIA-certified clinical laboratory for analysis by gas isotope ratio mass spectrometry (GIRMS). The GIRMS platform is a validated, FDA-approved analytical system for conducting GEBT breath analyses. GEBT test results are presented in a comprehensive gastric emptying profile report and provided to the ordering clinician.

"While scintigraphy has historically been used to confirm the diagnosis of gastroparesis, it requires referral to specialized outpatient centers and exposes patients to radiation," said Kerry Bush, president and chief operating officer, Cairn Diagnostics. "As a result, scintigraphy is frequently used later in the diagnostic pathway, if at all. Diagnosis is challenging because symptomology is a poor predictor of the presence or absence of gastroparesis. Symptoms may be the same for different itiologies of gastroparesis and other conditions such as dyspepsia, GERD and peptic ulcer disease often present with the same constellation of complaints that accompany gastroparesis.2 This challenging pathway contributes to patients often being treated empirically. However, without confirmation of delayed gastric emptying, clinical outcomes may be uncertain and add additional burden to the patient."

Gastroparesis

It is estimated that there are 5.8 million patients with suspected gastroparesis in the United States. The most common forms are diabetic, idiopathic and post-surgical gastroparesis, which is sometimes associated with vagotomy and vagus nerve injury. Some pharmacologic agents, especially narcotic opiate analgesics, anticholinergic agents and some diabetic medications cause gastroparesis. In diabetics, glycemic control is important as glucose levels greater than 200 mg/dl may induce gastroparesis.2 Post-viral infection gastroparesis may occur. Other rarer causes of gastroparesis include diseases affecting neural control (such as Parkinson's, amyloidosis and paraneoplastic disease).

Principles of GEBT

The Cairn GEBT helps to identify gastroparesis by measuring the rate of excretion of a special form of carbon dioxide in the patient's breath. Patients consume a precisely-formulated egg mixture containing pharmaceutical-grade Spirulina platensis, a safe and nutritional blue green algae, that has been enriched with carbon-13. Carbon-13 is a rare and naturally occurring, safe, non-radioactive form of carbon. Consuming the 13C-enriched test meal gives rise to 13CO2. The rate of 13CO2 excretion at any measurement time t is proportional to the rate of gastric emptying.

Cairn GEBT Manufacturing Process

The Cairn GEBT is a product that has both medical device and drug components. Manufacturing activities are conducted in strict compliance with FDA regulations as mandated in the Code of Federal Regulations, Title 21 – Food and Drugs. Specifically, manufacturing is conducted consistent with the applicable requirements of 21 CFR Part 4 – cGMP for Combination Products, 21 CFR Parts 210 & 211 – cGMP in Manufacturing, Processing, Packing or Holding of Drugs and Finished Pharmaceuticals  and 21 CFR Part 820, Quality System Regulation.

References

1.  Szarka L, Camilleri M, Vella A, et al. A Stable Isotope Breath Test with a Standard Meal for Abnormal Gastric Emptying of Solids in the Clinic and in Research. Clin. Gastroenterol H. 2008; 8: 635-643.
2.  Clinical Guidelines: Management of Gastroparesis. American Journal of Gastroenterology, VOLUME 108 | JANUARY 2013

About Cairn Diagnostics

For many diseases and conditions, 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 Diagnostics is based in Brentwood, Tennessee. For more information, please visit www.cairndiagnostics.com.

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cairn-diagnostics-launches-fda-approved-spirulina-gastric-emptying-breath-test-for-gastroparesis-300242140.html


'/>"/>
SOURCE Cairn Diagnostics
Copyright©2016 PR Newswire.
All rights reserved


Related medicine technology :

1. MGC Diagnostics Corporation to Report Second Quarter Fiscal 2013 Financial Results on Thursday, May 30, 2013
2. Alzheimer Market: Drugs, Therapeutics & Diagnostics Research Reports
3. Apnix Sleep Diagnostics Announces New Houston Sleep Apnea Treatments
4. MGC Diagnostics Corporation Reports 2013 Second Quarter Operating Results
5. QIAGEN Expands Pipeline of Promising New Biomarkers for Development of Personalized Healthcare Companion Diagnostics
6. Accelerate Diagnostics Announces Plans For Rights Offering To Stockholders
7. In Vitro Diagnostics - A Global Market Overview
8. Global In Vitro Diagnostics Markets Outpace Pharma Industry Growth, finds Frost & Sullivan
9. Quest Diagnostics CEO Steve Rusckowski Reaffirms Full-Year 2013 Guidance At The Jefferies 2013 Global Healthcare Conference
10. Quest Diagnostics and Hologic Form Strategic Alliance to Improve Womens Health
11. Strand Diagnostics and Manhattan Labs Partner to Create myPAP test
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/15/2018)... ... August 15, 2018 , ... Allegheny ... on a new full-service hospital in Pine Township that will bring a wide ... suburbs. , Expected to open in 2021, AHN Wexford Hospital will ...
(Date:8/15/2018)... ... August 15, 2018 , ... Schioppa ... casters. The newly designed Diamond Series features a caster specifically engineered for ... an antimicrobial compound injected into a thermoplastic resin during molding, Diamond Series casters ...
(Date:8/14/2018)... ... August 14, 2018 , ... ... their first-ever summer harvest employment and hands-on educational program developed for students throughout ... a high school, junior college or university, spent a minimum of 6 weeks ...
Breaking Medicine Technology:
(Date:8/15/2018)... , ... August 15, 2018 , ... Many people might ... surgery to achieve it. That’s where a great new option comes in: Injectable filler, ... to Sonoa Au, MD of Advanced Dermatology P.C. , An increasingly popular ...
(Date:8/14/2018)... SAN DIEGO (PRWEB) , ... August 14, 2018 ... ... KMC University, will be the keynote speaker at ChiroTouch Connect User Conference. The ... by the Florida Chiropractic Association (FCA). , ChiroTouch is ecstatic to have ...
(Date:8/14/2018)... MELBOURNE, Fla. (PRWEB) , ... August 14, 2018 , ... ... the next generation of freezing fat, at Clevens Face and Body Specialists. Dr. Clevens ... success to patients at his Melbourne and Merritt Island offices. Along with his associate, ...
(Date:8/11/2018)... ... August 11, 2018 , ... Financial Voyages LLC ... the Executive of the Year-Business category in The 15th Annual International Business Awards®. ... individuals and organizations worldwide – public and private, for-profit and non-profit, large and ...
(Date:8/9/2018)... ... August 09, 2018 , ... RiverGlade Capital ... Operating Partner and will have an exclusive relationship with the firm. As ... strategic planning, human capital sourcing, and deal origination, evaluation and diligence. He ...
Breaking Medicine News(10 mins):