Real-time Monitoring of Cancer Progression

■ Easier, Non-Invasive, and Repeatable Sampling Method

Generally, when patients have a tumor in the breast, lung, or colon, they undergo imaging examinations. Tissue samples of the tumor are also taken via invasive methods, such as needle biopsy or surgery, to aid in greater diagnostic accuracy. However, these invasive methods are often limited by the number of samples that can be taken, the size of the samples, and organ tissue.

Most human DNA exists within cells and after a cell dies, its DNA is released into the bloodstream and becomes cell-free DNA (cfDNA). Similarly, the DNA of a tumor cell that has died is also released into the bloodstream, thereby becoming circulating tumor DNA (ctDNA). The technique of detecting ctDNA in blood samples is called Liquid biopsy. ctDNA can immediately reveal the current genetic variations in a patient's tumor, which enable more effective monitoring of cancer status and earlier detection of recurrence or new mutations. Liquid biopsies therefore help doctors in assessing treatments and continuous monitoring.

■ First Blood-based Tests Covering All Four Mutation Classes

■ Latest NGS Technology: Detect Low Frequency Alleles with Exceptional Sensitivity and Specificity

Generally, there are 168 billion cfDNA molecules in 4 mL of plasma and about 0.1% ctDNA molecules or 168 million ctDNA molecules from tumor in 4 mL of plasma. With approximately 9 ctDNA molecules EGFR T790M mutation, How do we find 9 molecules in billions of cfDNA molecules? We applied CAncer Personalized Profiling by deep Sequencing (CAPP-Seq), a novel next-generation sequencing-based approach for ultrasensitive ctDNA detection and combined advanced error suppression through molecular and bioinformatics approaches, iDES (integrated digital error suppression), which greatly improve the sensitivity and specificity of the detection of low-frequency alleles in ctDNA.

iDES enables the reduction of errors：Increasing error-free positions from 65% to 98%. Reducing wide error rate ~15 fold

■ Provides a Complete and Accurate Genomic Profile into Different Stages and Types of Cancer

*Reference：

1. Nature Medicine. 2014;20(5):548-554.

2. Science Translational Medicine. 2016;8(364):364ra155

3. Nature Biotechnology. 2016;34(5):547-555.

4. Nature Reviews Cancer. 2017; 17:223-238.

■ SOFIVA Cancer Monitor

Patients with solid tumors who:

•assessing the effectiveness of their therapy

•using ctDNA as their tracking indicator

•are unable to provide tissue samples regularly

■ SOFIVA Cancer Track

Patients with solid tumors who:

•assessing the effectiveness of their therapy

•using ctDNA as their tracking indicator

•are unable to provide tissue samples regularly

*SOFIVA Cancer Track：only for patients tested SOFIVA Cancer Monitor before

Real-time Monitoring of Cancer Progress and Early Detection of Genetic Mutations

Regular blood tests to detect ctDNA can help determine whether relevant genetic mutations have occurred in patients and provide a reference for targeted therapy. Unlike conventional imaging and biochemical examinations, ctDNA provides more current information on the tumor within a patient’s body, thereby enabling more effective monitoring and greater efficacy of therapy. Recurrence or new mutations can also be detected earlier so treatment strategies can be promptly adjusted.

■ Performance

Step 1：Physician or nurse explains test procedure

Step 2：Sign consent form and provide blood or FFPE sample

Step 3：Sample delivered to laboratory

Step 4：Using newest illumina® NGS technology

Step 5：The report is completed in 10 working days

*This test can only serve as a reference for professional medical personnel. Please consult your doctor regarding the clinical meaning of the results or any other medical issues.

Validation Study has been published in Top-tier Journals

■ Extremely Sensitive and Specific Quantitation of ctDNA

■ Early Detection of Cancer Relapse

■ iDES Enables the Reduction of Errors

2017 ASCO Clinical Validation

■Early Predict of Clinical Outcomes through SOFIVA Cancer Monitor