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Biocartis Idylla™ EGFR Mutation test pack (6 tests/pack), CE-IVD

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Tootekood A0060/6

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For professional/laboratory use only.

IdyllaTM EGFR provides fast, reliable information on the EGFR tumor mutation status reducing the clinical turnaround time from sample to result report significantly. This can make EGFR test results available at the same time as PD-L1 as recommended by the NCCN guidelines.1 Insufficient samples are a persistent problem in lung cancer genomic profiling resulting in a high invalid/ rejection rate. IdyllaTM EGFR only requires 1 tissue section (5-10 µm) per assay and shows a significant lower invalid rate compared to other methods.

The fully automated IdyllaTM EGFR Mutation Test covers 51 mutations in exons 18–21 in a single cartridge using only 1 FFPE tissue section from metastatic NSCLC showing a high concordance of >95% compared with reference methods.

· 51 EGFR mutations in exons 18, 19, 20 and 21
· 150 minutes assay turnaround time
· <2 minutes hands-on time
· Only 1 slice of FFPE tissue required
· Highly sensitive & standardized
· Suitable for any lab

Spetsifikatsioonid

Spetsifikatsioonid
Pack Size

6 tests/pack

Sample Type

1 x 5 µm FFPE tissue section

Analytical sensitivity

LOD <  5% for most prevalent EGFR mutations

Total turnaround time

150 minutes

Dokumendid

Idylla_EGFR-IVD_Tech-Sheet.pdf

Idylla EGFR IVD Technical Sheet

EN | 148,597 KB

Download

Specimen_Req.pdf

Specimen Requirements

EN | 115,054 KB

Download

Idylla-Brochure_2024-10-10-153116_sczq.pdf

EN | 3,128 MB

Download

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