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In the era of precision medicine, accurate diagnosis is the prerequisite
for precision treatment.
"dEGFR39" digital PCR panel detection reagent (Epbay Bio) detects 39 mutation sites of EGFR in a single pass, including common mutation sites such as L858R, 19Del and T790M, and rare mutation sites such as L861Q, S768I, G719X, C797S (cis/trans) and 20ins, comprehensive evaluation of performance and verification of liquid biopsy ctDNA clinical samples.
Its practical effects on efficacy monitoring and other related academic results are listed in the British Journal of Cancer "Plasma-based early screening and monitoring of EGFR mutations in NSCLC patients by a 3-color digital PCR assay"
。
At present, there are three common nucleic acid detection technologies: real-time PCR (qPCR), high-throughput sequencing (NGS) and digital PCR
。 qPCR is suitable for more conventional clinical molecular detection items, and NGS is suitable for detecting unknown sequences, unknown mutations, and high-throughput multi-locus detection.
Due to the advantages of high sensitivity, absolute quantification, easy operation, fast results and high cost performance, digital PCR-based dEGFR39 breakthrough simultaneous detection multi-site quantitative detection has significant advantages
in the clinical quantitative detection application of tumor liquid biopsy.
Lung cancer is a malignant tumor with the highest incidence and mortality in China, targeted therapy has a significant effect in patients with advanced non-small cell lung cancer (NSCLC) with positive driver gene, and epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have become the routine treatment
of NSCLC.
With the deepening of clinical research, the mutational status of EGFR has also developed into multiple monitoring of the whole course of the disease to cope with the changing condition
.
Circulating tumor DNA (ctDNA) is an excellent marker for drug-accompanied diagnosis and real-time disease progression, but its low content and high background noise pose high challenges
for detection methods.
Digital PCR technology has excellent sensitivity and specificity, and with higher throughput, more complete sites and lower cost detection reagents, it will be able to analyze ctDNA more comprehensively and quickly, and can better serve the clinic in the
future.
Professor Song Xiang's team from Cangzhou Central Hospital and Professor Chu Li's team from the Provincial Key Laboratory of Liver and Kidney Disease Research in Integrated Traditional Chinese and Western Medicine of Hebei College of Traditional Chinese Medicine cooperated with Aipbay Biotechnology to comprehensively evaluate the performance of the "digital PCR panel detection" technology, and verified its practical effect on ctDNA efficacy monitoring with clinical samples
。
In this study, retrospective FFPE tissues of 30 patients with NSCLC and paired tissue and plasma samples of 33 patients with NSCLC were collected for analysis
.
Based on the "dEGFR39" digital PCR panel detection reagent and the Naica droplet chip digital PCR system, 39 mutation sites of EGFR can be detected in a single pass, including common mutation sites such as L858R, 19Del and T790M, as well as L861Q, S768I, G719X, C797S (cis/ trans) and rare mutation sites such as 20ins
.
The "dEGFR39" detection reagent has extremely high sensitivity
.
The study compares the linear relationship between expected mutational abundance (0.
01%, 0.
05%, 0.
1%, 1%, 10%) and measured abundance, andR2 is close to 1
.
In the plasma of P-15 in patients treated with eclitinib for 368 days, in addition to the original L858R mutation, the emergence of the resistance site T790M has been detected in dEGFR39, 121 days
earlier than radiographic disease progression.
Similarly, in patients with P-25 with the 19Del mutation, the emergence
of drug-resistant mutation sites was observed 43 days in advance of imaging.
In patients P-23, the abundances of L858R detected by dEGFR39 continued to decline with the treatment of eclitinib, and CT also showed that the patient was effective
.
After that, it was found that the abundance of T790M increased, and the patient's condition became stable
after changing the treatment plan in time.
Patient P-23
The "dEGFR39" panel detection method based on Naica digital PCR technology is reliable, sensitive, fast and has multiple sites, which shows obvious advantages
in predicting drug resistance, treatment monitoring and clinical prognosis after EGFR-TKIs treatment.
Based on Naica CN digital PCR and other technology platforms, Aipbay Biotechnology (Suzhou) Co.
, Ltd.
has continuously developed dozens of genetic testing products for the important genes in tumor precision medicine, providing detection reagents for genetic characteristics at various stages of cancer treatment, making liquid biopsy a confirmatory method for personalized diagnosis and treatment plans, better evaluating the effectiveness of treatment plans, and assisting in the formulation of personalized treatment plans
。 The company adheres to product quality and focuses on technological innovation, and will provide more high-quality products and comprehensive services
for clinical practice in the future, including companion diagnosis, efficacy monitoring, prognosis evaluation, cancer screening, etc.
At the same time, Epbay Biotech provides professional LDT solutions
based on advanced digital PCR platform and independent patented detection technology.
for precision treatment.
"dEGFR39" digital PCR panel detection reagent (Epbay Bio) detects 39 mutation sites of EGFR in a single pass, including common mutation sites such as L858R, 19Del and T790M, and rare mutation sites such as L861Q, S768I, G719X, C797S (cis/trans) and 20ins, comprehensive evaluation of performance and verification of liquid biopsy ctDNA clinical samples.
Its practical effects on efficacy monitoring and other related academic results are listed in the British Journal of Cancer "Plasma-based early screening and monitoring of EGFR mutations in NSCLC patients by a 3-color digital PCR assay"
。
At present, there are three common nucleic acid detection technologies: real-time PCR (qPCR), high-throughput sequencing (NGS) and digital PCR
。 qPCR is suitable for more conventional clinical molecular detection items, and NGS is suitable for detecting unknown sequences, unknown mutations, and high-throughput multi-locus detection.
Due to the advantages of high sensitivity, absolute quantification, easy operation, fast results and high cost performance, digital PCR-based dEGFR39 breakthrough simultaneous detection multi-site quantitative detection has significant advantages
in the clinical quantitative detection application of tumor liquid biopsy.
Lung cancer is a malignant tumor with the highest incidence and mortality in China, targeted therapy has a significant effect in patients with advanced non-small cell lung cancer (NSCLC) with positive driver gene, and epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have become the routine treatment
of NSCLC.
With the deepening of clinical research, the mutational status of EGFR has also developed into multiple monitoring of the whole course of the disease to cope with the changing condition
.
Circulating tumor DNA (ctDNA) is an excellent marker for drug-accompanied diagnosis and real-time disease progression, but its low content and high background noise pose high challenges
for detection methods.
Digital PCR technology has excellent sensitivity and specificity, and with higher throughput, more complete sites and lower cost detection reagents, it will be able to analyze ctDNA more comprehensively and quickly, and can better serve the clinic in the
future.
Professor Song Xiang's team from Cangzhou Central Hospital and Professor Chu Li's team from the Provincial Key Laboratory of Liver and Kidney Disease Research in Integrated Traditional Chinese and Western Medicine of Hebei College of Traditional Chinese Medicine cooperated with Aipbay Biotechnology to comprehensively evaluate the performance of the "digital PCR panel detection" technology, and verified its practical effect on ctDNA efficacy monitoring with clinical samples
。
Research Methods:
In this study, retrospective FFPE tissues of 30 patients with NSCLC and paired tissue and plasma samples of 33 patients with NSCLC were collected for analysis
.
Based on the "dEGFR39" digital PCR panel detection reagent and the Naica droplet chip digital PCR system, 39 mutation sites of EGFR can be detected in a single pass, including common mutation sites such as L858R, 19Del and T790M, as well as L861Q, S768I, G719X, C797S (cis/ trans) and rare mutation sites such as 20ins
.
Research Results:
The "dEGFR39" detection reagent has extremely high sensitivity
.
The study compares the linear relationship between expected mutational abundance (0.
01%, 0.
05%, 0.
1%, 1%, 10%) and measured abundance, andR2 is close to 1
.
In the plasma of P-15 in patients treated with eclitinib for 368 days, in addition to the original L858R mutation, the emergence of the resistance site T790M has been detected in dEGFR39, 121 days
earlier than radiographic disease progression.
Similarly, in patients with P-25 with the 19Del mutation, the emergence
of drug-resistant mutation sites was observed 43 days in advance of imaging.
In patients P-23, the abundances of L858R detected by dEGFR39 continued to decline with the treatment of eclitinib, and CT also showed that the patient was effective
.
After that, it was found that the abundance of T790M increased, and the patient's condition became stable
after changing the treatment plan in time.
Patient P-23
Conclusions:
The "dEGFR39" panel detection method based on Naica digital PCR technology is reliable, sensitive, fast and has multiple sites, which shows obvious advantages
in predicting drug resistance, treatment monitoring and clinical prognosis after EGFR-TKIs treatment.
Based on Naica CN digital PCR and other technology platforms, Aipbay Biotechnology (Suzhou) Co.
, Ltd.
has continuously developed dozens of genetic testing products for the important genes in tumor precision medicine, providing detection reagents for genetic characteristics at various stages of cancer treatment, making liquid biopsy a confirmatory method for personalized diagnosis and treatment plans, better evaluating the effectiveness of treatment plans, and assisting in the formulation of personalized treatment plans
。 The company adheres to product quality and focuses on technological innovation, and will provide more high-quality products and comprehensive services
for clinical practice in the future, including companion diagnosis, efficacy monitoring, prognosis evaluation, cancer screening, etc.
At the same time, Epbay Biotech provides professional LDT solutions
based on advanced digital PCR platform and independent patented detection technology.
Aipbay Biotechnology (Suzhou) Co.
, Ltd
Aipbay Biotechnology (Suzhou) Co.
, Ltd.
is a national high-tech enterprise and a leading talent enterprise in Suzhou, and has passed ISO13485 and ISO9001 quality system certification
.
Obtained a number of national authorized patents and software copyrights related to nucleic acid microdetection and digital PCR detection
.
Approved a number of product registration certificates and product filing certificates
related to multiple PCR technology platforms.
It has a solid foundation and rich experience in hardware and software such as molecular biology research and experimental technology, and has built a rapid PCR, rapid quantitative PCR, international leading digital PCR detection platform, microscopic imaging acquisition and analysis and other instrument research and development platforms; It has built a micronucleic acid detection and development platform, continued to develop clinical testing products for molecular diagnostic tests such as molecular and cytogenetic testing related to diseases and targeted drug guidance, and has a highly skilled R&D team to undertake a number of provincial and ministerial technology research and development projects
.
