OncoSweep Cancer Spotlight and Spectrum Product Line

OncoSweep Cancer Spotlight and Spectrum Product Lines are qualitative in vitro diagnostic devices testing plasma specimens for detecting circulating miRNA expression, ctDNA methylation status, platelet RNA analysis, and tumor marker expressions by utilizing real-time polymerase chain reaction (qPCR) and next-generation sequencing (NGS). This is a two-arm, open-label, non-randomized controlled pilot study intends to screen adults 18 years or older, who are treatment-naïve for cancers and have pulmonary nodules or mass detected by low-dose computerized tomography (LDCT) or standard computerized tomography (CT) scans. OncoSweep Lung Spotlight will be utilized with venous blood samples collected in the healthcare facility where the study is being conducted. The X-ray, LDCT/ standard CT scan, blood laboratory test data, or biopsy results will be collected from the control group, and the blood sample will be analyzed by OncoSweep Lung Spotlight. Results generated from both groups will be evaluated against each other. The result of OncoSweep Lung Spotlight provides additional evidence to support or assist medical diagnoses when used in combination with LDCT/ standard CT scan data.

Inclusion criteria

• Inclusion

• Individual who is not mentally impaired, capable to read, understand, and is willing to provide signed and dated informed consent form.
• Individual is aged 18 years old or above.
• Individual who is willing to provide information on the given questionnaire. Test group: Individual was diagnosed with pulmonary nodules or masses by low-dose CT (LDCT)/ CT, and evaluated by the physician needed to conduct a biopsy or/ and surgery has been arranged.

Control group: Individual is willing to undergo LDCT or CT scan with 3-5 mm spatial z-axis resolution, pulmonary function examination, X-ray, laboratory blood test, and blood drawing.

• Control group: Individual has no abnormal finding from LDCT or CT scan with 3-5 mm spatial z-axis resolution and pulmonary function examination(FEV1/FVC Ratio≧70%).
• Individual did not donate blood or receive blood transfusion within two months before joining the study.

Exclusion criteria

• Exclusion

• Individual who is not suitable for participating as per Investigator's judgement.
• Individual who has undergone gene therapy or related product within one year prior to enrolling in this study.
• Individual who is attending another clinical study at the time of enrollment.
• Individual who is known to be pregnant.
• Individual who has received a vaccine within two weeks.
• Individual who has a history of any cancer occurrences other than lung cancer.