Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech

Diagnostic Blood Panel Eyed for Patients With Diarrhea-Predominant IBS

June 9, 2016 By Commonwealth Laboratories, LLC

A health economic analysis has indicated potential cost savings associated with the use of the diagnostic blood panel IBSchek for patients suffering from diarrhea-predominant irritable bowel syndrome (IBS-D), according to Commonwealth Laboratories, LLC. 

The study, published in Clinical Therapeutics, utilized a cost-minimization decision tree model, a budget impact analysis, as well as physician surveys to compare the economic values.

IBSchek is a simple blood test designed to help physicians diagnose IBS, the most common gastrointestinal disorder in the U.S., which affects approximately 40 million Americans. IBSchek identifies the presence of two antibodies in a blood specimen – anti-CdtB and anti-vinculin. Elevated levels of either of these antibodies can confirm a diagnosis of diarrhea-predominant IBS (IBS-D) or IBS-Mixed (IBS-M).

The blood test uses a well-established immunoassay method called ELISA that can be conducted on a specimen collected via a standard blood draw. Results are reported to the physician 24 hours after the patient’s blood specimen is received by Commonwealth for analysis.

The results of the study showed that using the IBSchek diagnostic blood panel may result in both greater efficiencies in diagnosing IBS as well as cost savings to the healthcare system. A budget impact analysis estimates that, when the cost savings are amortized over one million lives, the blood panel will save healthcare payers more than $3.5 million annually.  

A cost-minimization decision tree model predicts an estimated $509 cost savings versus the exclusionary diagnostic pathway, which is the current standard of care. Additionally, the exclusionary diagnostic pathway was estimated conservatively in this study, according to Commonwealth. It did not consider repeated investigations (i.e., multiple colonoscopies), the potential for more invasive studies stemming from false-positive results of the investigations, or the cost of pathology assessments. 

“The financial and emotional toll of diagnosing IBS is substantial – diagnosis takes an average of 6.6 years, and patients typically consult with more than four healthcare providers about their symptoms, which adds up to many physician visits, tests and suffering,” Mark Pimentel, MD, director of the Pimentel Laboratory at Cedars-Sinai, said in a press statement. “IBSchek can help diagnose IBS patients earlier so physical symptoms may be treated, resulting in a reduction of the financial burden of IBS on both patients and the healthcare system.”

Traditionally, a diagnosis of IBS was made only after excluding other gastrointestinal conditions, such as Crohn’s disease and ulcerative colitis. This exclusionary process takes time and often requires patients to undergo costly and invasive medical procedures, such as colonoscopies, computed tomography scans, and endoscopies, among others. The invasive diagnostic procedures may have risks for patients, who can experience complications such as bacterial infection, hemorrhage and bowel perforation. 

Several methods were utilized in the study to estimate the potential cost savings of using the IBSchek diagnostic blood panel, including:

  • A cost-minimization decision tree model for gastroenterology practices in the United States was constructed to compare two differing diagnostic strategies. This model predicts that use of the novel IBS diagnostic blood panel may result in an estimated cost savings of $509 [per patient], by allowing patients to proceed to treatment earlier, thereby avoiding unnecessary testing. The cost savings are dependent on the probability a test result would lead to treatment.
     
  • A budget impact analysis was performed for a hypothetical health plan with one million covered lives. The prevalence of IBS was estimated from medical literature with analysis performed for the U.S. population aged 18-64. Analysis computes the difference in net costs for two scenarios: 1) 100 percent of eligible patients are diagnosed with the exclusionary pathways; 2) 50 percent of eligible patients are diagnosed with the IBS diagnostic blood panel pathway.
     
  • Two surveys were developed and completed by nine expert gastroenterologists from primarily academic centers in the United States. The first survey looked at physician and patient characteristics (e.g., insurance type, patient distribution by subtype, time to diagnosis, etc.). The second survey addressed the same variables in the first survey, but in a more detailed manner.

Researchers disclosed several limitations when interpreting the study data, including the wide range of response in the surveys and survey sample size, the potential for physicians to initiate treatment before conducting testing, and that the decision to send a patient for treatment is affected by individual biomarker outcomes.

Related Articles Read More >

Dexcom One
How Dexcom’s portfolio goes beyond highly-anticipated next-gen G7
A portrait of Stryker executive Siddarth Satish
How Stryker includes users for product design in the digital age
A Medtronic HVAD pump opened up to show the inner workings
Medtronic investigates HVAD pump welds after patient deaths
Galien Foundation 2022 nominees
18 of the world’s most innovative medical technologies

DeviceTalks Weekly.

May 20, 2022
DeviceTalks Boston Post-Game – Editors’ Top Moments, Insulet’s Eric Benjamin on future of Omnipod 5
See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

Enewsletter Subscriptions

Enewsletter Subscriptions

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech 100 Index
  • Medical Tubing + Extrusion
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to E-newsletter
  • Attend our Monthly Webinars
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2022 WTWH Media, LLC. All Rights Reserved. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • Med Tech Resources
    • DeviceTalks Tuesdays
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Medical Device Handbook
    • MedTech 100 Index
    • Podcasts
    • Print Subscription
    • The Big 100
    • Webinars / Digital Events
    • Whitepapers
    • Video
  • 2022 Leadership in MedTech
    • 2022 Leadership Voting!
    • 2021 Winners
    • 2020 Winners
  • Women in Medtech