Clinical Services—Pervenio™ Lung NGS assay

Delivering results on small biopsies and challenging tumor samples

Pervenio™ Lung NGS assay

Pervenio Lung NGS assay

Since launching the Pervenio™ Lung NGS assay in Feb. 2014, we have experienced a <2% QNS (quantity not sufficient) rate in testing patient samples.

 

* "Quantity not sufficient" samples for the period Mar. 1–Sep. 30, 2014.


Sample requirements1

Blocks
Single paraffin-embedded tissue block containing the highest percentage of tumor; or
Slides
Ten 7 μm unstained sections mounted on slides for each specimen to be tested. Each slide must be clearly labeled with the institutional block number.

1 Contact us for details.

We have core expertise optimizing assays and the workflows for challenging clinical samples. We select technologies and products that are most appropriate for small samples. In development and validation, assays are optimized to generate results on small and challenging samples with low tumor content and less than optimal DNA yield.

The Pervenio™ Lung NGS test provides current, clinically relevant, and well-referenced information for >400 genomic alterations

As of September 2014, we have processed >500 lung samples, of which 15% are cytology samples (including fine-needle aspirates), and 25% have <20% tumor content. Using microdissection, we have been able to enrich tumor content and successfully generate results on 98% of the samples processed.

Understand the genetic make-up of your patient's tumor

Given the dynamic nature of drug development, our therapeutic and clinical trial information database is updated monthly to help ensure the most current information for physicians and patients.

Our licensed team generates results in a well-referenced report typically within seven business days after receipt of sample. These reports include:

  • Mutation analysis in 22 genes, including EGFR, BRAF, and KRAS
  • Translocation analysis for 3 genes1: EML4-ALK, RET, and ROS1

Comprehensive report

  • All genomic alterations detected (mutations and translocations) in the tumor tissue
  • Available therapies that target each detected genomic alteration
  • FDA-approved drugs for NSCLC and other cancers with links to the FDA website
  • A list of open clinical trials on NSCLC with the detected genomic alteration as an enrollment criterion. Information on cancer stage, trial ID, phase, locations, contact information, and links to trial websites from clinicaltrials.gov also is provided.

Pervenio™ Lung NGS assay analytical performance

The Pervenio™ Lung NGS panel was developed in our lab using various technologies and products, including the Ion PGM™ Sequencer, the Ion AmpliSeq™ Colon and Lung Cancer Research Panel v2, Ion Reporter™ software, QuantStudio® real-time PCR instruments and assays, the Oncomine® Knowledgebase, and the RecoverAll™ Total Nucleic Acid Isolation Kit for FFPE.

The assay was validated under CLIA guidelines using FFPE lung samples and cell lines.

Analytical Sensitivity >99% at >5% allele frequency for mutation, >99% at >1% total mRNA
Analytical Specificity >99%
Accuracy >99%
Repeatability >99% at >5% allele frequency
Reproducibility >99% at >5% allele frequency

Billing and reimbursement support

We bill insurance for testing services. We work with patients to manage appeals, and with physicians' offices to simplify pre-certifications. Patients are kept informed throughout the process. We offer reimbursement assistance for under-insured patients, based on financial need. Please contact us for more information.

Life Technologies Clinical Services Lab tests are intended for clinical use. They were developed and their performance characteristics determined by the Life Technologies Clinical Services Lab, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity testing. The tests have not been cleared or approved by the United States Food and Drug Administration; however, such clearance or approval is not currently required.