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SOFIVA Monitor+/SOFIVA Monitor


Real-time Monitoring of Tumor Dynamics

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Introduction


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.

Indication


■ SOFIVA 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 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



*Patients need to test SOFIVA Drug+/SOFIVA Monitor+ before SOFIVA Monitor testing


Description


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.







■ SOFIVA Monitor+


197 genes


NCCN guideline recommended genes


FDA-approved drugs


◆includes some Global Clinical Trials drugs


■ SOFIVA Monitor


Detecting mutated genes identified in previous test, used as a reference for monitoring disease progression and treatment response evaluation in patients with NED1or CR2


Note:


1. NED:no evidence of disease


2. CR:complete response


*For patients who are about to undergo targeted therapy for the first time or a new treatment strategy after recurrence, detecting SOFIVA Drug+can help doctors find suitable target drugs or global clinical trial drugs to serve as the basis for their treatments.


■ Performance


Patient Story


How It Works


Step 1:Physician or nurse explains test procedure


Step 2:Sign consent form and provide blood sample


Step 3:Sample delivered to laboratory


Step 4:Using newest illumina® NGS technology


Step 5:The report is completed in 14 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.

Others


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 Monitor+