Mimix™ OncoMatch™ Lung Cancer Positive, FFPE Reference Standard

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The Mimix™ OncoMatch™ Lung Cancer Positive FFPE Reference Standard (TMB score 48) serves as a matched tumor control for paired tumor-normal analysis. It can be used alongside the Lung Cancer Negative, FFPE Reference Standard (TMB score 19) to support identification of somatic variants using molecular biology assays such as qPCR, ddPCR, Sanger sequencing and NGS.

Molecular diagnosis of lung cancer often requires precise differentiation between somatic and germline variants. The Mimix OncoMatch lung cancer positive FFPE reference standard provides a matched tumor control derived from the same individual as our lung cancer negative reference material (HD853, available separately). When used together, they support laboratories to confidently verify pipelines and identify true cancer-associated variants by filtering out germline polymorphisms that could otherwise lead to false positives in tumor-only testing approaches. This FFPE reference material comes with Tumor Mutational Burden (TMB) score, a biomarker widely used to predict  an individual’s response to immune checkpoint inhibitors.

Our Mimix reference standards are produced under ISO 13485 and undergo rigorous QC testing, leveraging over 14 years of experience in reference material development. Each batch is thoroughly characterized using whole exome sequencing to confirm the presence of lung cancer specific variants while maintaining the appropriate germline background.  This means you can trust in the quality of our controls for greater confidence in your results.

If you need a FFPE reference standard with your preferred blend of tumor and matched normal lung cell lines, we can provide a made-to-order control. You can define the desired tumor-to-normal ratio or your desired TMB score, and we’ll create customized FFPE reference material derived from lung tumor and matched normal cell lines that meet your requirement. Enquire now using our made-to-order options.

Key features:

• Representative matched lung tumor and normal samples from the same genetic background
• Unedited, single source reference standard for patient-like performance
• Prepared in FFPE format to mimic patient samples, for end-to-end workflow verification
• Facilitates paired tumor-normal analysis when used with the matched lung cancer negative reference standard (HD853)
• Well-suited to creating custom dilution series with the negative reference standard to precisely challenge and establish LOD for molecular assays
• Batch-specific WES data for verification of NGS workflows, confirming the variants
• TMB score
• Made-to-order options available for preferred tumor-to-normal blends
• ISO 13485 manufacturing: Produced under stringent quality management systems with extensive documentation and lot-specific quality control metrics

Batch-specific NGS data

The Mimix OncoMatch Lung Cancer Positive FFPE reference standard comes with batch-specific NGS data. You can access the VCF file here. Each batch was sequenced using Agilent's CREV4 (Clinical Research Exome) kit at a depth of 250x on Illumina platform and ran through the Illumina DRAGEN Somatic Tumour-Normal Pipeline for mapping, sorting, and variant calling.

Technical Product Information

Format: FFPE

Section size: 15µm

Cell density: 150 x 10⁶ cells per block. Approx. 4.5 x 10⁵ cells per section

Expected DNA yield: ≥400 ng using Promega Maxwell RSC FFPE Plus DNA Extraction kit

Genes covered: Please refer the VCF file for mutations

Allelic frequencies: None claimed (refer to VCF file)

TMB score: 48

Key Variants present (confirmed via NGS):

General information

Storage: 4°C

Shipping: Ambient

Expiration: See all product shelf life information

Quality control

DNA Quantification: Quantifluor®

DNA Integrity: Agarose Gel electrophoresis

Manufacturing Quality: ISO 9001:2015 and ISO 13485:2016.

For research use only. Not for use in diagnostic procedures.

FAQ

•  At what temperature do you ship reference standards?
•  How are OncoMatch reference standards different to other products?
•  How can I open the NGS data .gz files?
•  How do you manufacture your Horizon Reference Standards?
•  How do you recommend extracting DNA from an FFPE reference standard?
•  How was the batch-specific supplementary NGS data produced and analysed?
•  Is it possible to order custom versions of Horizon Reference Standard?
•  The FFPE yield is lower than expected, how can I improve the yield?
•  What batch-specific supplementary NGS data is provided?
•  What is TMB? How is it calculated for our reference standards?
•  Where can I access batch-specific supplementary NGS data?
•  Why do I see different allele frequencies or different variants in my NGS data when comparing to the data provided with the reference standard?