Specimen Collection Study for H. Pylori Testing

This is a prospective study designed to acquire and bank human specimens from subjects who
are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be
conducted at a minimum of 2 sites in the United States. Investigator sites will enroll
prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF)
provided by the sponsor will be used to capture basic demographic information (DOB, age,
gender, race/ethnicity), medication history, and related clinical information. The CRFs will
also record the results of the following tests performed with the gastric biopsy tissue
specimens: histology and rapid urease test (RUT).

Inclusion Criteria:

- Aged 21 and to 75 years.

- Able to read, speak, and understand English or have access to a translator in
subject's native language.

- Patients without prior H. pylori eradication treatment.

- Currently not on proton pump inhibitors, antibiotics or bismuth

- Discontinuation at least 2 weeks prior to endoscopy and specimen collection.

- Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain]

- Undergo gastric biopsies as part of routine care

- Physician able to provide histology and rapid urease result on biopsy specimens.

Exclusion Criteria:

- Aged less than 21 years old or older than 75 years

- Unable to provide consent.

- Patients with a history of prior H. pylori eradication therapy.

- Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not
discontinue

- Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen
fundoplication, or Roux-en-Y.

- Any unstable or poorly-controlled medical or psychiatric condition.