genetic tests for malignant tumor (solid tumor)

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genetic tests for malignant tumor (solid tumor)

Laboratory：Hachioji

○genetic tests for malignant tumor (solid tumor)

TEST NAME	SPECIMEN REQUIREMENT （ｍL）	CONTAINER	CAP COLOR	STORE TEMPERATURE (STABILITY)	TURNAROUND TIME (DAY)	METHODOLOGY	REFERENCE RANGE (UNIT)
BRAF V600 mutation analysis, PCR	unstained slides 5-10 sildes thickness：10μm	Z10			4-10	PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.
BRAF exon15 V600E (SEQ)	unstained slides	Z10			11-14	Direct sequencing method Direct sequencing method Direct sequence analysis using PCR-amplified DNA as a sequencing template.
EGFR mutation analysis v2.0	unstained slides 5-10 sildes thickness：10μm	Z10			3-6	PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.
EGFR mutation analysis v2.0 (plasma)	plasma 5.0	PK5,PK7 ↓ ARR			3-6	PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.
EGFR gene mutational analysis (Scorpion-ARMS technique)	unstained slides 5-10 sildes thickness：5-10μm	Z10			4-7	PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.
Qualitative detection of ROS1 gene fusions	tissues 100mg	ARR			4-7	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	Negative
Qualitative detection of ROS1 gene fusions	pleural fluid sediment	ARR			4-7	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	Negative
Qualitative detection of ROS1 gene fusions	bronchoalveolar lavage fluid sediment	ARR			4-7	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	Negative
Qualitative detection of ROS1 gene fusions	bronchial brushing lavage fluid sediment	ARR			4-7	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	Negative
Qualitative detection of ROS1 gene fusions (FFPE)	unstained paraffin sections 5paraffin sections	ARR			4-7	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	Negative
Qualitative detection of ROS1 gene fusions (FFPE)	unstained slides 5 sildes thickness：5μm	Z10			4-7	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	Negative
EML4-ALK fusion gene, qualitative	pleural fluid sediment	ARR		（3 days）	7-11	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	None-detected
EML4-ALK fusion gene, qualitative	bronchoalveolar lavage fluid sediment	ARR		（3 days）	7-11	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	None-detected
EML4-ALK fusion gene, qualitative	bronchial brushing lavage fluid sediment	ARR		（3 days）	7-11	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	None-detected
EML4-ALK fusion gene, qualitative	tissues 100mg	ARR		（3 days）	7-11	RT-PCR(Real-time PCR) Real-time PCR Real-time PCR is the one of the nucleic acid amplification tests using polymerase chain reaction (PCR) as the basic principle. By the use of oligonucleotide that yields fluorescence after degradation, the fluorescent signal is identified for each PCR cycle, which enables the real-time quantification of the target nucleic acid.	None-detected
PIK3CA mutation analysis, SEQ	unstained slides	Z10			11-14	Direct sequencing method Direct sequencing method Direct sequence analysis using PCR-amplified DNA as a sequencing template.
c-kit mutation analysis (GIST)	tissues 250mg	ARR			11-23	Direct sequencing method Direct sequencing method Direct sequence analysis using PCR-amplified DNA as a sequencing template.
c-kit mutation analysis (GIST)	unstained slides	Z10			11-23	Direct sequencing method Direct sequencing method Direct sequence analysis using PCR-amplified DNA as a sequencing template.
RAS/BRAF gene mutational analysis	unstained slides 5 sildes thickness：5-10μm	Z10			4-7	PCR-rSSO
Microsatellite instability (MSI) test (FFPE)	unstained slides 5-10 sildes thickness：5μm	Z10			4-8	Multiplex PCR-fragment analysis Multiplex PCR-fragment analysis After amplifying multiple target genes, capillary electrophoresis is performed on PCR amplicons by sequencer. Separated according to DNA size, the amplified peaks are analyzed and identified by the dedicated software with the predetermined QMVR width as a reference.
Microsatellite instability (MSI) test (FF)	tissues 50mg	ARR			4-8	Multiplex PCR-fragment analysis Multiplex PCR-fragment analysis After amplifying multiple target genes, capillary electrophoresis is performed on PCR amplicons by sequencer. Separated according to DNA size, the amplified peaks are analyzed and identified by the dedicated software with the predetermined QMVR width as a reference.
IDH1/2 gene analysis (Glioma) (FFPE)	unstained slides 5–10 sildes thickness：4-10μm	Z10			11-14	Direct sequencing method ダイレクトシーケンス法 PCR法で増幅したDNAを鋳型として直接塩基配列を決定する方法。
Oncomine Dx Target Test CDx system(FFPE)（Suspended beyond orders placed 02-27-2021）	unstained slides 5-10 sildes thickness：5μm	Z10			11-14	Next-generation sequencing (NGS) method Next-generation sequencing (NGS) method A method for simultaneous determination of nucleotide sequences of a large amount of DNA fragments using a next generation sequencer.
Oncomine Dx Target Test CDx system(FF)（Suspended beyond orders placed 02-27-2021）	tissues 100mg	ARR			11-14	Next-generation sequencing (NGS) method Next-generation sequencing (NGS) method A method for simultaneous determination of nucleotide sequences of a large amount of DNA fragments using a next generation sequencer.
IDH1/2 gene analysis (Glioma) (FF)	tissues 125mg	ARR			11-14	Direct sequencing method
NCC Oncopanel System	unstained slides+whole blood 5 sildes thickness：10μm + 2.0	Z10+PK2			16ｰ22	Next generation sequence (NGS) method
Foundation One CDx Cancer genome profile	unstained slides+slide for HE staining 10 sildes thickness：4-5μm + 1 slide for HE staining	Z10			16-19	Next generation sequence (NGS) method
Oncomine Dx Target Test Multifor research 46 genes analysis (FF)（Suspended beyond orders placed 12-28-2021）	100mg	ARR			7ｰ11	Next generation sequence (NGS) method
IDH1/2 gene analysis(Glioma)（Suspended beyond orders placed 10-31-2019）	tissues 250mg	ARR			12-16	Direct sequencing method Direct sequencing method Direct sequence analysis using PCR-amplified DNA as a sequencing template.
Oncomine Dx Target Test Multi-CDx System 4 genes analysis (FFPE)（Suspended beyond orders placed 12-28-2021）	unstained slides 5–10 sildes thickness：5μm	Z10			7-11	Nextgeneration sequence(NGS)method
Oncomine Dx Target Test Multi-CDx System 4 genes analysis (FF)（Suspended beyond orders placed 12-28-2021）	tissues 100mg	ARR			7-11	Next generation sequence (NGS) method
Oncomine Dx Target Test Multifor research 46 genes analysis (FFPE)（Suspended beyond orders placed 12-28-2021）	unstained slides 5–10 sildes thickness：5μm	Z10			7ｰ11	Next generation sequence (NGS) method

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○genetic tests for malignant tumor (solid tumor)

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