What Cairn Diagnostics does

Cairn Diagnostics, operating as Advanced Breath Diagnostics, LLC, is a privately held medical diagnostics company headquartered in Brentwood, Tennessee, that has developed and commercializes the 13C-Spirulina Gastric Emptying Breath Test (GEBT), the only FDA-approved breath test for diagnosing gastroparesis. The company's core technology uses pharmaceutical-grade Spirulina (blue-green algae) enriched with the non-radioactive stable isotope Carbon-13 as a substrate; after ingestion, breath samples are analyzed via gas isotope ratio mass spectrometry (GIRMS) in a CLIA-certified laboratory to measure the rate of solid-phase gastric emptying at six timepoints over a four-hour evaluation period. The test holds FDA Pre-Market Approval (PMA 110015, granted April 2015) and a PMA supplement (PMA 110015 S008, granted August 2021) for telehealth-based at-home administration, which Cairn has combined with direct-to-patient kit shipping and remote clinical supervision.

The company generates revenue under a transactional diagnostic services model billed under CPT code 91065, with Medicare coverage approved in July 2020 and an increasing share of commercial payers following. Its go-to-market operates through two complementary channels: a prescription-based provider ordering channel (physicians, nurse practitioners, and physician assistants order via fax or email, with kits shipped to patients) and a direct-to-consumer telehealth administration channel that eliminates the need for nuclear medicine facility visits. The addressable market is approximately 5 million US adults living with gastroparesis, and the test is recommended in ACG and AGA clinical guidelines. Cairn maintains ISO 13485:2016 certified facilities in Brentwood (headquarters, kit manufacturing, and CLIA lab) and Franklin (13C-Spirulina API production), and handles payer billing and appeals on behalf of provider practices. The company is founder-led, with Kerry Bush serving as President and COO, and operates with no disclosed external institutional funding, partnerships, or acquisitions.

Name

Cairn Diagnostics

Legal name

Advanced Breath Diagnostics, LLC

Website

https://cairndiagnostics.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Cairn Diagnostics is a privately held Tennessee-based diagnostics company that provides the FDA-approved 13C-Spirulina Gastric Emptying Breath Test (GEBT) for diagnosing gastroparesis in adult patients, serving healthcare providers through prescription-based and telehealth-enabled at-home testing under CPT code 91065.

Ownership category

akta.pro rank

Product category

Gastrointestinal Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Point-of-Care Testing (POCT) & Near-Patient Labs (HLAFAMAI)

akta.pro secondary industry

Point-of-Care & Decentralized Trial Testing Services (HLAGAEAK)

Keywords

• Breath diagnostics
• Gastroparesis testing
• Gastric emptying tests
• Medical diagnostic services
• At-home diagnostic testing

Headquarters

HQ city

Brentwood

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Supply Chain, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Diagnostic Testing Services: Cairn Diagnostics generates revenue through providing the 13C-Spirulina Gastric Emptying Breath Test (GEBT) diagnostic service. Healthcare providers order the test for patients with suspected gastroparesis. The test kit is shipped to the patient's home, clinical administration is performed via telehealth or in-office, breath samples are analyzed in the CLIA-certified laboratory, and results are reported to the ordering provider. Billed under CPT code 91065.
2. Insurance and Medicare Billing: GEBT is covered by Medicare (coverage approved July 2020) and an increasing number of commercial insurance payers. Cairn Diagnostics handles all billing and appeals on behalf of provider practices, working directly with payers to ensure smooth claims processing and providing transparent patient communication regarding coverage.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels5 records

Core offering

Cairn Diagnostics provides the 13C-Spirulina Gastric Emptying Breath Test (GEBT), an FDA-approved, non-radioactive breath-based diagnostic test for gastroparesis. Healthcare providers order the test, a kit is shipped directly to the patient's home, breath samples are analyzed in a CLIA-certified laboratory using gas isotope ratio mass spectrometry, and results are reported back to the ordering provider. The company also operates a telehealth-enabled administration model allowing at-home completion of the 4-hour test under remote clinical supervision.

Product overview

Cairn Diagnostics offers the ¹³C-Spirulina Gastric Emptying Breath Test (GEBT) as its core diagnostic product—a single FDA-approved test for diagnosing gastroparesis. The GEBT can be administered either in a physician's office or via Cairn's telehealth administration service, where patients complete the 4-hour test at home under virtual supervision. The company's product portfolio centers on this one test, with complementary resources including a Breath Test Timer app for patient use. The GEBT kit is shipped directly to patients' homes, and breath samples are analyzed in Cairn's CLIA-certified laboratory with results delivered to ordering providers.

Differentiator

Problem solved

Functional benefit

Products and services

• 13C-Spirulina Gastric Emptying Breath Test (GEBT) FDA-approved, non-radioactive breath test that measures the rate of solid-phase gastric emptying to aid in diagnosing gastroparesis in symptomatic adults. The patient consumes a pre-measured test meal containing 13C-Spirulina (pharmaceutical-grade Spirulina enriched with Carbon-13 stable isotope), and breath samples are collected at 6 timepoints over a 4-hour period. Samples are analyzed using gas isotope ratio mass spectrometry (GIRMS) in a CLIA-certified laboratory and reported using the kPCD metric. The test is prescribed and ordered by healthcare providers (physicians, NPs, PAs).
• GEBT Telehealth Administration Service Remote virtual supervision and administration of the GEBT test via telehealth, allowing patients to complete the 4-hour test at home with real-time clinical support from Cairn's clinical team through scheduled video calls. Eliminates the need for in-person visits to a nuclear medicine facility and expands access to rural and underserved populations.

Quantifiable outcome

• 73-97% agreement with gastric scintigraphy results
• +3 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Exact Sciences: Exact Sciences is a major GI-focused diagnostics company with non-invasive colorectal cancer screening tests, sharing the gastroenterology channel and non-invasive testing theme but addressing a different indication.
• Laboratory Corporation of America (Labcorp): Labcorp is a national clinical laboratory operator offering a wide range of diagnostic testing services including GI panels; it overlaps with Cairn through lab-based diagnostic services but does not specialize in breath-based gastroparesis testing.
• Quest Diagnostics: Quest Diagnostics operates a national CLIA-certified clinical laboratory network offering specialty GI diagnostics including gastric emptying scintigraphy; it competes as a broad incumbent diagnostic services provider rather than as a breath-test specialist.
• Otsuka Holdings: Otsuka has historically developed and commercialized 13C-urea breath tests for H. pylori, sharing Cairn's 13C breath test technology foundation and gastroenterology channel while addressing a different indication.

Direct peers

• Medtronic: Medtronic markets the SmartPill wireless motility capsule system, which directly competes with GEBT as a non-scintigraphy alternative for gastroparesis diagnosis in the same gastroenterology ordering workflow.
• Exalenz Bioscience (Meridian Bioscience): Exalenz developed 13C-labeled urea breath tests for H. pylori and other 13C-based GI breath diagnostics, sharing Cairn's 13C stable isotope breath-test platform approach and overlapping gastroenterology customer base.

Emerging players

• Anixa Biosciences: Anixa Biosciences has been developing breath-based diagnostic tests for cancer detection, sharing Cairn's breath-based testing modality and clinical laboratory business model while addressing a different clinical indication.

Others

• Cambridge Isotope Laboratories: Cambridge Isotope Laboratories manufactures stable isotope-labeled compounds including 13C substrates used in clinical breath tests, serving as an enabling supplier/peer in the 13C breath testing ecosystem that supports Cairn's substrate manufacturing.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks1 record

Key highlights1 record

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Cairn Diagnostics