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Liquid Biopsy
In recent years, the concept of liquid biopsy is gradually accepted and recognized by physicians. As an effective supplement to tissue biopsy, it can not only assist in diagnosis of solid tumors, but also actualize drug resistance and recurrence monitoring and therapeutic efficacy evaluation. It is discovered by studies that there is a small number of cell-free DNA (i.e. plasma cell-Free DNA, cfDNA) in the blood of cancer patients, and a part of these cell-free DNA comes from tumor cells; these genome segments free in the blood are called ctDNA (i.e. circulating tumor DNA). The ctDNA is one of the liquid biopsy specimens; the method of acquiring the gene variation information correlated with cancers through detection of ctDNA released into blood from tumor tissue is "liquid biopsy".

 The traditional molecular companion diagnostic always needs to be based on tissue specimens. As a new tumor marker, ctDNA plays an important role in the areas such as individualized tumor medication detection and recurrence and therapy efficacy monitoring. First, ctDNA-based liquid biopsy can be an effective supplement to biopsy, for it can largely reduce the sufferings and risks brought by collection of specimens to the patients receiving first- or second-line tumor therapy, especially to the advanced-stage cancer patients from whom the biopsy specimens cannot be acquired; Second, ctDNA-based liquid biopsy can genuinely restore the panorama of tumor, for ctDNA may be released into the peripheral blood by all tumor focus (including primary focus and metastasis focus) due to the spatial tumor heterogeneity which leads to an inaccurate reflection of the panorama of tumor by biopsy; And last, ctDNA-based liquid biopsy can actualize dynamic blood collecting at different time point, actualize dynamic monitoring in tumor therapy process, and may discover the occurrence of drug-resistance molecular mechanism earlier than imaging, while biopsy cannot monitor in real time the tumor evolvement and drug resistance due to the temporal tumor heterogeneity.

 Advantages of the peripheral blood circulating tumor DNA (ctDNA) detection
1) Applicable to the patients who cannot tolerate a biopsy, and a substitute for risky invasive specimen detection;
2) Will not be limited by focus position and cancer type;
3) Capable of avoiding the problem of tissue specimen heterogeneity, and can genuinely reflect the overall view of gene variation in patients;
4) Actualize a dynamic monitoring of therapy efficacy and disease progress.

Liquid biopsy is one of the top ten breakthrough techniques in 2015 released by MIT Technology Review. Specialist consensus on liquid biopsy is reached at the 13th lung Cancer Summit Forum in March 2016; It is pointed out by the specialist consensus that "the consensus three【the NGS method is recommended in detection, by liquid biopsy, of multiple known targets which can be inhibited clinically by medication in parallel】, and the consensus four 【the NGS method is suggested to use in liquid biopsy for discovering of unknown gene, exploring of the therapy efficacy monitoring, prediction of prognosis and discovering of the drug resistance mechanism and so on】". Liquid biopsy has wide application prospects in precise tumor therapy.

Next generation sequencing-based ctDNA liquid biopsy can actualize a parallel multi-gene detection of multiple targets, having very high sensitivity and specificity. Burning Rock Dx launches two non-invasive gene detection products for individualized tumor medication—"Lungplasma" and “Lung core(blood version)”for the patients with non-small-cell lung carcinoma and "Pureplasma" for the patients with other solid tumors.

Lung cure™-The Blood Version
Burning Rock Lung cure™–the blood version, developed for the patients with advanced-stage non-small-cell lung carcinoma, can detect the 8 genes recommended by NCCN Guidelines all at once, based on the peripheral blood ctDNA as detection specimen and on the advanced technique of targeted sequencing plus next generation sequencing, covering all targeting medicines for non-small-cell lung carcinoma approved by FDA and cFDA, and can provide precise and comprehensive reference information for the formulation of a personalized therapy plan for the clinical first-line patients with non-small-cell lung carcinoma from whom sufficient tissue specimens cannot be acquired.
Lung-cure™ (Blood Version)

Product Features

Precise Detection:Detect the 8 genes recommended by NCCN guidelines on non-small-cell lung carcinoma all at once, providing precise molecular diagnosis basis for subsequent clinical individualized therapy;
Wide Application:Applicable to the first-line patients with advanced-stage non-small-cell lung carcinoma from whom sufficient tissue specimens cannot be acquired, providing patients with the greatest probability of obtaining precise therapy;

Comprehensive and Precise:Capable of detecting mutation, fusion, copy number amplification, insertion and deletion in parallel all at once in the aspect of ctDNA, with the ultra-high sequencing depth greater than 10000X, and can accurately detect the ultra-low abundance variation as low as 0.2%, breaking through the limitation of the past monitoring method;
 

Excellent Performance

Compared to NGS tissue detection, ctDNA liquid biopsy provided by Burning Rock has a specificity of 98% and a hot spot mutation (e.g. L858R, T790M) sensitivity of 93%, can detect fusion (e.g. ALK) and get the precise information about the cleavage sites in the aspect of ctDNA, keeping pace with the international level.

Applicable Populations

The patients with advanced-staging non-small-cell lung carcinoma who cannot tolerate the biopsy mode such as needle biopsy;
The first-line patients with multiple metastatic non-small-cell lung carcinoma.

Lungplasma™
Burning Rock Lungplasma™, developed for the patients with advanced-stage non-small-cell lung carcinoma, can detect the 168 genes highly correlated with lung carcinoma all at once, based on the peripheral blood ctDNA as detection specimen and on the advanced technique of targeted sequencing plus next generation sequencing, covering all targeting medicines as approved by FDA and cFDA, recommended by NCCN Guidelines, under clinical trials, and approved by FDA for the cancers of other types, and can provide an effective dynamic detection method in the whole therapy process while providing precise molecular diagnosis basis for the clinical second-line patients from whom sufficient tissue specimens cannot be acquired.

Targeted Drugs Covered in Lungplasma™

 

Product Features

Precise Detection: Detect the 168 genes correlated with lung carcinoma all at once, covering the targets for all targeting medicines as currently approved by cFDA and FDA, recommended by guidelines, under clinical trials and approved for the cancers of other types, providing comprehensive and precise molecular diagnosis basis for subsequent clinical individualized therapy;

Wide Application: Applicable to the second-line patients with advanced-stage non-small-cell lung carcinoma from whom sufficient tissue specimens cannot be acquired, providing precise molecular diagnosis basis, therapy effect prediction, and recurrence and disease monitoring for the patients;

Comprehensive and Precise: Capable of detecting mutation, fusion, copy number amplification, insertion and deletion in parallel all at once in the aspect of ctDNA with the ultra-high sequencing depth greater than 10000X, and can accurately detect the ultra-low abundance variation lowering to 0.2%, breaking through the limitation of the past monitoring method;

Excellent Performance: Compared to NGS tissue detection, ctDNA liquid biopsy provided by Burning Rock has a specificity of 98% and a all-site sensitivity of 85%, and can detect fusion (such as ALK) and get the precise information of the cleavage sites in the aspect of ctDNA, effectively avoiding the problem of heterogeneity of tissue specimens and actualizing real-time dynamic monitoring.

Applicable Populations

The second-line patients with non-small-cell lung carcinoma who cannot tolerate the biopsy mode such as the needle biopsy;

The patients with advanced-stage non-small-cell lung carcinoma in poor physical condition on whom a biopsy cannot be performed.

The patients who has a requirement of a dynamic monitoring of advanced-stage targeting therapy efficacy and disease progress.
Case Sharing
A 46-year-old woman diagnosed with advanced-stage lung adenocarcinoma by fiber-optic bronchoscopy, and with EGFR-19 Del identified by molecular diagnosis, keeps administering the third-generation EGFR-TKI after developing drug resistance of first-generation EGFR-TKI, with Liver metastases PD and other metastases PR being identified. Since the patient cannot tolerate the needle biopsy at that time, so detection by Burning Rock "Lungplasma" is performed, and then the liquid biopsy is performed subsequently at five time points in the following therapy process for dynamic monitoring of the therapy efficacy and disease progress.
 
 
The first blood detection: On April 2, the detection shows the EGFR-19Del was still the driver mutation and EML4-ALK fusion was present. The liver metastasis was suspected to be driven by the EML4-ALK fusion. The patient showed a systemic improvement after additional administration of crizotinib based on the detection results.

The second blood detection: On June 3, the detection results, after two months of combined administration of targeting medicine, suggested the mutation abundances of EGFR-19Del and ALK fusion were largely reduced, which was in complete accord with the clinic characterization.

The third blood detection: On June 30, the liver metastases PD was identified in the patient, which suggested that the drug resistance of crizotinib was developed, and new metastases were present. The blood detection results showed elevated mutation abundances of EGFR-19Del and ALK fusion. Then the patient was medicated with the 2nd generation ALK inhibitor.

The forth blood detection: On July 27, the liver metastases CR was identified after medicated with the 2nd generation ALK inhibitor; The detection by Lungplasma showed that the ALK fusion disappears and the driver mutation EGFR T790M was present, with new metastases continuing growth. it was suspected that the alternative pathway of new metastases was activated, which avoids the inhibition by the 3rd generation EGFR-TKI.

The fifth blood detection: The last detection on August 17 by Lungplasma ™showed that the EGFR C797S mutation was present, which was the acquired drug resistance loci, reported by ASCO in 2015, against the 3rd generation EGFR TKI, which suggested that the mutation for drug resistance of 3rd generation EGFR TKI was present in the patient.