Gulf Coast Scientific

What Gulf Coast Scientific does

Gulf Coast Scientific, Inc. is a privately held medical device company founded around 1994 and headquartered in Oldsmar, Florida. It develops, manufactures, and distributes diagnostic products targeting H. pylori infection under the PyloPLUS+ brand, and is expanding into pulmonary diagnostics via the Allora sub-brand. The product portfolio centers on three categories: rapid urease tests (the PyloPLUS+ Ultra Rapid Urease Test, CLIA WAIVED with reported 100% sensitivity and specificity and results in as little as one minute), urea breath test kits (UBT1 with pre-crushed urea powders and UBT2 featuring a proprietary two-way air valve breath collection bag and an all-in-one mixing-and-serving urea pouch), and hardware analyzers offered in 2-port, 4-port, and 16-port configurations with touchscreen or USB-to-Windows interfaces, integrated self-calibration, and LIS compatibility for laboratory throughput scaling. Notable technical differentiators include a dry-test format requiring no reagents or refrigeration (2+ year room-temperature shelf life), horizontal bag hook-up design that prevents saliva contamination of analyzers, and dedicated CPT reimbursement codes (83013, 83014).

The company sells directly to healthcare facilities — clinics, endoscopy units, hospitals, and laboratories — via phone (1-877-855-4100), email, and customer support, with distribution extending internationally across the medical community. Revenue is generated primarily through hardware sales of analyzers plus recurring consumable kit sales. The Allora BreathTest, a 10-minute lung bacterial infection breath test, is in late-stage clinical development, representing a deliberate vertical expansion beyond gastroenterology. No parent company, institutional investors, or M&A activity are disclosed; ownership appears founder- or management-held, and no funding rounds, partnerships, or leadership team details were identified in the source material.

Name

Gulf Coast Scientific

Legal name

Gulf Coast Scientific, Inc.

Website

https://gulfcoastscientific.com

Company type

Private

Founded year

1994

Operating status

Operating

Headcount range

11–50 employees

Short description

Gulf Coast Scientific develops and manufactures diagnostic medical devices for H. pylori detection under the PyloPLUS+ brand, including rapid urease tests, urea breath test kits, and 2/4/16-port analyzers. It sells directly to clinics, endoscopy units, hospitals, and labs globally, with the Allora BreathTest in pulmonary diagnostics in late-stage clinical development.

Ownership category

akta.pro rank

Product category

Diagnostic Medical Devices

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Infectious Disease POCT (Respiratory, STI, HIV, Sepsis) (HLAHAOAA)

akta.pro secondary industry

Pulmonary Function Testing (PFT) & Respiratory Diagnostics (HLAKANAC)

Keywords

• H. pylori diagnostics
• Urea breath tests
• Rapid urease testing
• Diagnostic medical devices
• Point-of-care testing

Headquarters

HQ city

Oldsmar

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Diagnostic Medical Device Sales: Sale of medical diagnostic products including urea breath test kits, rapid urease tests, and analyzers to healthcare facilities

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Gulf Coast Scientific develops, manufactures, and distributes diagnostic medical products primarily for H. pylori detection. Its portfolio includes the PyloPLUS+ brand of urea breath test kits (UBT1 and UBT2), a rapid urease test (RUT) for gastric biopsies, and hardware analyzers in 2-port, 4-port, and 16-port configurations. The company also has the Allora BreathTest in late-stage clinical development for pulmonary infection detection.

Product overview

Gulf Coast Scientific is a multi-faceted company specializing in the development, manufacture, and distribution of innovative diagnostic medical products. The product portfolio centers on the PyloPLUS+ brand for H. pylori diagnostics, including rapid urease tests (RUT), urea breath test kits (UBT1 and UBT2), and a range of hardware analyzers (2-port, 4-port, and 16-port configurations). The company also has Allora BreathTest in late-stage clinical development for pulmonary infection detection. The analyzers differ primarily in throughput capacity and connectivity options, from compact point-of-care 2-port units to high-throughput 16-port automated analyzers for laboratory settings. Both test kits and analyzers are designed with reimbursement codes (CPT codes 83013, 83014) and regulatory compliance (CLIA status varies by product).

Differentiator

Problem solved

Functional benefit

Brands

• PyloPLUS+: Primary product brand for diagnostic solutions including urea breath test kits and analyzers for H. pylori detection
• Allora

Products and services

• PyloPLUS+ Ultra Rapid Urease Test (RUT) A rapid urease test for H. pylori detection in gastric biopsies, offering 100% sensitivity and specificity with results in as little as one minute (negative in one hour). CLIA WAIVED, requires no refrigeration, and can be stored at room temperature for over 2 years. Designed for use in CLIA-waived endoscopy units by nurses or technicians with minimal training.
• PyloPLUS+ UBT2 Urea Breath Test Kit A urea breath test kit for H. pylori detection featuring two-way air valve breath collection bags enabling patient re-sampling. Includes all-in-one urea pouch design that serves as mixing and serving device, eliminating the need for plastic cups. Achieves 100% sensitivity and specificity in clinical trials (98.4% sensitivity, 99.2% specificity for patients on PPI medication). CLIA non-regulated.
• PyloPLUS+ UBT1 Urea Breath Test Kit A urea breath test kit for H. pylori detection featuring pre-crushed, easily dissolved urea and flavoring powders in a space-saving package.
• PyloPLUS+ Two-Port UBT Analyzer A compact two-port urea breath test analyzer with one-button touchscreen interface, horizontal bag hook-up design preventing saliva contamination, LIS compatibility, and quick definitive test results. Dimensions: W 7.6" x D 17.7" x H 9.4", 19.8 lbs.
• PyloPLUS+ Four-Port UBT Analyzer A four-port urea breath test analyzer with compact footprint, intuitive software operations, USB interface for Windows-based computers, and integrated self-calibration. Dimensions: W 13.8" x D 8.3" x H 9.4".
• PyloPLUS+ Sixteen-Port UBT Analyzer A high-throughput sixteen-port urea breath test analyzer with automated batch analysis processing, press-and-walk-away operation, intuitive automated operations, and integrated self-calibration for lab throughput. Dimensions: W 16.1" x D 17.3" x H 9.3", 41 lbs.
• Allora BreathTest A breath test for detecting lung bacterial infections in 10 minutes, currently in late-stage clinical development as an innovative expansion beyond gastroenterological diagnostics into pulmonary infection detection.

Quantifiable outcome

• 100% Sensitivity and 100% Specificity in clinical trials for H. pylori detection
• +3 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

Feature5 records

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Direct peers

• Meridian Bioscience: Long-standing direct competitor in H. pylori diagnostics (Premier Platinum HpSA stool antigen test and breath test product lines); now part of Revvity. Direct overlap in target customers (clinical labs, hospitals) and H. pylori detection category.
• Otsuka Pharmaceutical: Markets the HeliKit urea breath test for H. pylori detection. Direct competitor in UBT-based H. pylori diagnosis with similar end-user customers (clinics, hospitals) and overlapping CPT-reimbursed testing workflow.
• Exalenz Bioscience: Developed the BreathID system for H. pylori breath testing. Direct peer in non-invasive UBT-based H. pylori diagnostics, competing for the same point-of-care and lab testing customers.
• EKF Diagnostics: Provides H. pylori diagnostic products including GastroPanel. Overlaps with Gulf Coast Scientific in H. pylori testing menus and clinical laboratory customers across multiple geographies.
• Sekisui Diagnostics: Offers H. pylori testing products in its clinical chemistry/immunoassay portfolio. Direct peer in the H. pylori diagnostic category serving hospitals and reference labs.

Broad incumbents

• Bio-Rad Laboratories: Large diagnostics incumbent offering H. pylori IgG ELISA and broader infectious-disease testing menus. Competes with Gulf Coast Scientific for the same hospital and lab customers, but as part of a much wider diagnostics portfolio.
• QuidelOrtho: Major POCT and clinical diagnostics player. Overlaps with Gulf Coast Scientific in CLIA-waived point-of-care infectious disease testing and competes for physician-office and hospital POC adoption.
• Abbott Diagnostics: Global diagnostics giant offering broad infectious-disease and GI pathogen testing on central lab and POC platforms. Competes with Gulf Coast Scientific in H. pylori testing as part of a much larger infectious-disease portfolio.
• QIAGEN: Molecular diagnostics leader with products targeting GI pathogens. Overlaps with Gulf Coast Scientific in infectious-disease testing workflows serving hospital and reference lab customers.
• DiaSorin: Specialty diagnostics company with infectious-disease and gastroenterology testing menus. Competes with Gulf Coast Scientific in H. pylori and adjacent GI infectious-disease testing categories.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

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 Gulf Coast Scientific