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Simple answers to complex questions.

Aspyre® Clinical Tests give oncologists, pathologists and their patients the insights they need to make quicker, more informed decisions.

Aspyre is genomics for all.

Aspyre Clinical Tests provide simple, fast and reliable biomarker testing, ensuring that all patients have access to the best treatment options. With our advanced technology, patients can get access to the right treatment more quickly and more affordably than with other testing methods.

01

Simple

One assay to test all guideline-recommended genes associated with FDA-approved targeted therapies from tissue or blood.

02

Fast

98% of cases processed within 2 days, meaning patients can go from diagnosis to actionable biomarker results in a matter of days, not weeks.

03

Reliable

In a recent study, 98% of samples that failed next-generation sequencing (NGS) were rescued by Aspyre.1

Aspyre Clinical Test for Lung enables fast, confident treatment decisions.

Aspyre Clinical Test for Lung simultaneously analyzes DNA and RNA from blood or tissue in a single assay, maximizing the opportunity to identify DNA mutations and RNA fusions, while avoiding the additional time and expense of running separate assays.

Aspyre Clinical Test sample collection kits for Tissue and Blood

One test for tissue and blood.

Aspyre Clinical Test for Lung Can be used on either tissue or blood samples with tumor content as low as 10%. Whichever sample you submit, the test simultaneously analyzes DNA and RNA and covers all guideline-recommended genes for non-small cell lung cancer (NSCLC).

Two scientists work in Biofidelity's CAP-accredited, CLIA-certified laboratory

Aspyre Clinical Test for Lung is performed at Biofidelity’s CAP-accredited, CLIA-certified laboratory.

Analyzes all 11 guideline-recommended genes for NSCLC

Provides 2-day results in a simple, 2-page report

Simultaneously analyzes DNA & RNA from tissue or blood in a single test

Works with challenging samples and low DNA/RNA input


Coverage of 114 variants across 11 genes, including DNA and RNA biomarkers

Next-day results in a simple, 2-page report.

An example of Aspyre Clinical Test's two-page report.

Clinical data shows best-in-class performance across both tissue and blood sample types.

Reliable

  • 100% concordance with NGS
  • 100% specificity
  • 100% repeatability and reproducibility

Sensitive

  • Tissue analysis from as little as 10% tumor content
  • Gold-standard sensitivity from liquid biopsy

Aspyre Clinical Test for Lung by the numbers

100%

Specificity
DNA (SNVs & Indels)



3% VAF

Median panel-wide limit of detection 95%
DNA (SNVs & Indels)



100%

Specificity
RNA (Fusions)



100

Amplifiable copies
Median panel-wide limit of detection 95%
RNA (Fusions)



100%

Specificity
MET Exon 14 Skipping


200

Amplifiable copies
MET Exon 14 Skipping


100%

Specificity
DNA (SNVs & Indels)



0.3% VAF

Median panel-wide limit of detection 95%
DNA (SNVs & Indels)



100%

Specificity
RNA (Fusions)



6

Amplifiable copies
Median panel-wide limit of detection 95%
RNA (Fusions)



100%

Specificity
MET Exon 14 Skipping


100

Amplifiable copies
MET Exon 14 Skipping


The Aspyre Clinical Test for Lung is a Laboratory Developed Test (LDT). This test was developed and its performance characteristics determined by Biofidelity Inc. in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

Aspyre Lung Reagents

Want to bring Aspyre Lung into your own laboratory for research use? Aspyre Lung Reagents enable fast, simple, reliable detection of established biomarkers for use in NSCLC research.

Learn more