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 25 copies/rxn.
3
- Top sensitivity of 25 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. ROS1 gene fusions define a unique molecular 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.

Intended Use

The AmoyDx® ROS1 Gene Fusions Detection Kit is a real-time PCR assay for qualitative detection of 14 ROS1 gene fusions in human total RNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissues in NSCLC patients. The kit is intended to assess ROS1 gene status in NSCLC patients and to aid the clinician in identifying NSCLC patients who may response to ROS1 inhibitor therapy.

The kit is for in vitro diagnostic use, and intended to be used by trained professionals in a laboratory environment.

Testing Procedure
Compatible Sample Types:FFPE Samples
Compatible Real-time PCR Instrument
ABI 7500
LightCycler 480 II
SLAN-96S
Stratagene Mx3000P™
Other Info.

To order, please contact sales@amoydx.com.

 Product Name

 Size (test/kit)

 Storage

 ROS1 Gene Fusions Detection Kit (Pre-loaded)

 12T

 -20℃

 ROS1 Gene Fusions Detection Kit (Bulk)

 12T

 -20℃


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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