ROS1 Gene Fusions Detection Kit
PCR
Real-time PCR Assays
100%
100%
Accuracy
25 copies/μL
Sensitivity
100%
100%
Specificity
Features
Selectable
- Pre-loaded and bulk formats are available.
1
- Pre-loaded and bulk formats are available.
Universal
- Compatible with tissue samples.
2
- Compatible with tissue samples.
Precise
- Top sensitivity of 125 copies/rxn.
3
- Top sensitivity of 125 copies/rxn.
Easy
- Two steps procedure, results in 150 mins.
4
- Two steps procedure, results in 150 mins.
Reliable
- Internal control included.
5
- Internal control included.
Product Description

ROS1 Gene Fusions Detection Kit

ROS1 is a receptor tyrosine kinase of insulin receptor family. Chromosomal rearrangements involving the ROS1 receptor tyrosine kinase gene occur in a subset of non–small-cell lung cancer (NSCLC). The ROS1 fusion partners include SLC34A2, CD74, SDC4, EZR etc. These fusions lead to constitutive kinase activity and activation of downstream pathways, such as JAK/STAT, PI3K/AKT, RAS/MAPK etc., leading to carcinogenesis. It has been reported that the presence of the ROS1 rearrangement is correlated with the efficacy of TKI therapy.Based on analysis of tumor messenger RNA, ROS1 gene fusions can be detected by real-time PCR method.

Amoy Diagnostics has reached an agreement with OxOnc Development to use AmoyDx ROS1 Gene Fusions Detection Kit for a pivotal clinical trial of Pfizer's Xalkori (crizotinib) in Japan, Korea and China. Additional information is available at related news.

Technological Principles:

This kit is a nucleic acid amplifcation test for the qualitative detection of ROS1 gene fusions in NSCLC FFPE samples. The kit is based on three major processes: (1) specimen preparation to isolate total RNA from NSCLC FFPE samples; (2) reverse transcription of the target RNA to generate complementary DNA (cDNA); (3) simultaneous PCR amplification of target cDNA and detection of ROS1 gene fusions with specific primers and fluorescent probes.

Testing Procedure
Compatible Sample Types:FFPE Samples
Compatible Real-time PCR Instrument
ABI 7500
Bio-Rad CFX96
LightCycler 480 II
Rotor-Gene 6000
Rotor-Gene Q
SLAN-96S
Stratagene Mx3000P™
Other Info.

To order, please contact sales@amoydx.com.

AmoyDx ROS1 Gene Fusions Detection Kits are available in the following sizes:

 Product Name

 Size (test/kit)

 Storage

 Cat. No.

 ROS1 Gene Fusions Detection Kit (Pre-loaded)

 12T

 -20℃

8.01.23201W012A
8.01.23201W012B
8.01.23201W012D

 ROS1 Gene Fusions Detection Kit (Bulk)

 12T

 -20℃

8.01.23201X012H


Publications
1. Cai, W., et al. "ROS1 fusions in Chinese patients with non-small-cell lung cancer." Annals of Oncology 24.7 (2013): 1822-1827.
2. Cao, Bing, et al. "Detection of lung adenocarcinoma with ROS1 rearrangement by IHC, FISH, and RT-PCR and analysis of its clinicopathologic features." OncoTargets and therapy 9 (2016): 131.
3. Zhang, Limin, et al. "Efficacy of crizotinib and pemetrexed-based chemotherapy in Chinese NSCLC patients with ROS1 rearrangement." Oncotarget 7.46 (2016): 75145.
4. Wu, Yi-Long, et al. "Phase II study of crizotinib in East Asian patients with ROS1-positive advanced non–small-cell lung cancer." Journal of Clinical Oncology 36.14 (2018): 1405-1411.
5. Ju, Lixia, et al. "A lung squamous carcinoma patient with ROS1 rearrangement sensitive to crizotinib." Cancer chemotherapy and pharmacology 82.3 (2018): 561-564.
6. Zhang, Qing, et al. "Prevalence of ROS1 fusion in Chinese patients with non‐small cell lung cancer." Thoracic cancer 10.1 (2019): 47-53.
7. Bubendorf, Lukas, et al. "Testing for ROS1 in non-small cell lung cancer: a review with recommendations." Virchows Archiv 469.5 (2016): 489-503.
8. Shimizu, Junichi, et al. "Biomarker testing for personalized, first-line therapy in advanced nonsquamous non-small cell lung cancer patients in the real world setting in Japan: a retrospective, multicenter, observational study (the BRAVE study)." Therapeutic Advances in Medical Oncology 12 (2020): 1758835920904522.

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