Evaluating Diagnostic Performance of Spectra IMDx System for Detection of Gastric Cancer and Precancerous Lesions

Inclusion Criteria:

• The subject is older than 18 years of age.
• The subject is undergoing upper GI endoscopy for suspected intraepithelial neoplasia or gastric cancer lesions (less than 20mm)
• The subject must have personally signed and dated the patient informed consent form indicating that he/she has been informed of all pertinent aspects of the study.
• The subject must be willing and able to comply with all study procedures.

Exclusion Criteria:

• The subject has bleeding disorders, such as haemophilia, in whom biopsies are contraindicated.
• The subject shows presence of active gastrointestinal bleeding or coagulopathy precluding biopsies.
• The subject has rare gastric malignancies such as gastrointestinal stromal tumors (GISTs), lymphomas and neuroendocrine tumors （NETs）.
• The subject is pregnant.
• The subject with liver cirrhosis, impaired renal function, acute gastrointestinal (GI) bleeding, esophageal varices, jaundice, and GI post-surgery
• The subject with severe co-morbid illness, such as end-stage renal failure (ESRF), congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis (RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy
• The subject has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and in the judgment of the investigator would make the subject unsuitable for entry into the study
• The subject on regular anti-coagulant prophylaxis such as warfarin must be able to undergo a five-day washout period before gastroscopy. The subject on aspirin, ticlopidine and clopidogrel must be able to undergo a one-week washout period before gastroscopy. The subject's physician or study co-investigator will exercise their clinical judgement to ensure subject's safety.
• The subject is unwilling or unable to provide signed informed consent.