Altera

Altera™ Comprehensive Genomic Profiling, from Natera, is an advanced tumor genomic profiling test that analyzes the genetic changes and biomarkers present in tumor cells.

Using a combination of Whole-Exome Sequencing (WES) and Whole-Transcriptome Sequencing (WTS), Altera™ provides a broad molecular profile of the tumor, which may help physicians identify potential treatment options, immunotherapies, and relevant clinical trials.

 

Why is tumor genomic profiling important?

Every tumor has a unique molecular profile. The genetic changes present in a tumor may affect how it develops and how it may respond to different treatments.

Altera™ aims to identify these changes to provide physicians with more detailed molecular information about the tumor.

This information may help with:

  • identifying clinically relevant biomarkers;
  • evaluating targeted therapies;
  • evaluating immunotherapy options;
  • identifying potential mechanisms of resistance;
  • identifying potentially relevant clinical trials;
  • guiding a more personalized approach to treatment.

What does Altera analyze?

Altera™ uses two main sequencing methods:

Whole-Exome Sequencing – WES

WES analyzes approximately 20,000 genes, looking for genomic changes that may have clinical significance.

The analysis includes:

  • SNVs – single nucleotide changes;
  • Indels – insertions and deletions;
  • CNAs – copy number alterations;
  • certain gene rearrangements;
  • MSI – Microsatellite Instability;
  • TMB – Tumor Mutational Burden.

These data may help evaluate opportunities for targeted therapy, immunotherapy, and clinical trials.

Whole-Transcriptome Sequencing – WTS

WTS expands the analysis beyond the exome and helps identify:

  • structural rearrangements;
  • gene fusions;
  • clinically relevant transcripts;
  • NTRK1/2/3 fusions;
  • MET exon 14 skipping;
  • AR-V7;
  • EGFR vIII.

This may help identify certain biomarkers that may not be detected by more traditional profiling panels.

Biomarkers that may be evaluated

The Altera™ report may include information on various molecular biomarkers, including:

TMB – Tumor Mutational Burden

Measures the number of mutations identified in the tumor and may be important when evaluating potential immunotherapy options.

MSI – Microsatellite Instability

Assesses microsatellite instability, a biomarker that may be relevant in certain types of cancer and in evaluating treatment options.

PD-L1

Altera™ automatically includes assessment of PD-L1 (22C3) by immunohistochemistry (IHC).

HER2

The test also includes HER2 assessment by IHC, providing additional information that may help guide the treatment strategy.

 


 

Who is Altera™ recommended for?

Altera™ may be considered for patients diagnosed with cancer when molecular characterization of the tumor may help evaluate treatment options.

It may be particularly useful when the physician wants to:

  • identify actionable mutations;
  • evaluate biomarkers associated with immunotherapy;
  • explore other treatment options;
  • identify potentially suitable clinical trials;
  • better understand the molecular profile of the tumor.

The decision to perform the test is made by the physician based on the diagnosis, tumor material, and clinical situation.

What type of material is used for the test?

Altera™ is a tissue-based test, meaning that it is performed using material from the tumor.

Depending on the case, the material may be tumor tissue obtained during a biopsy or surgical procedure.

One of the advantages of the platform is that Altera™ can be ordered together with Signatera™ using the same tumor sample, helping preserve the available tissue material.

How can Altera™ help with treatment?

The Altera™ report may link the molecular changes identified in the tumor with:

  • targeted therapies;
  • immunotherapy;
  • potential mechanisms of resistance;
  • other potentially relevant treatments;
  • clinical trials that may target the identified alterations.

The report includes information on FDA-approved treatments, emerging therapeutic approaches, and clinical trials that may be associated with the identified mutations.

Important: the test result does not guarantee that a particular treatment will be effective. Treatment decisions are made by the oncologist, taking the patient's overall clinical situation into consideration.

 


 

What is treatment personalization?

Two patients with the same type of cancer may have different molecular changes in their tumors.

For this reason, the name of the cancer alone does not always provide all the information needed to evaluate treatment options.

Altera™ aims to provide an individualized molecular profile of the tumor so that the physician has more information to support treatment decisions.

What happens after the test?

After the sample is analyzed, a detailed report is prepared summarizing the genomic alterations and biomarkers identified.

The oncologist may use this information together with:

  • histopathological diagnosis;
  • disease stage;
  • medical history;
  • previous treatments;
  • other clinical characteristics.

This helps provide a more complete picture of the disease.

 

 

FAQs

01

What is Altera?

 

Altera™ is a Comprehensive Genomic Profiling (CGP) test that analyzes the genomic profile of a tumor to identify alterations and biomarkers that may be relevant to treatment.

02

Is Altera a blood test?

 

No. Altera™ is a tumor tissue-based test.

03

How many genes does it analyze?

 

WES analyzes approximately 20,000 genes, enabling very broad profiling of genomic alterations in the tumor.

04

Does it analyze DNA and RNA?

 

Yes. Altera™ combines Whole-Exome DNA Sequencing with Whole-Transcriptome RNA Sequencing.

05

Does it analyze TMB and MSI?

 

Yes. Altera™ includes assessment of TMB and MSI.

06

Does it analyze PD-L1?

 

Yes. Altera™ automatically includes assessment of PD-L1 (22C3) by IHC.

07

Does it analyze HER2?

 

Yes. Altera™ includes HER2 assessment by IHC.

08

Can it identify actionable mutations?

 

Yes. The profiling aims to identify molecular alterations that may be associated with targeted therapies or other treatment options.

09

Can it identify clinical trials?

 

Yes. The report may include clinical trials related to the molecular alterations identified.

10

Can Altera™ be used together with Signatera™?

 

Yes. Both tests can be ordered using the same tumor sample.

11

Is Altera™ the same as Empower™?

 

No. Altera™ profiles alterations in the tumor, while Empower™ evaluates inherited genetic changes associated with cancer predisposition.

12

Does Altera™ show whether a patient has cancer?

 

Altera™ is not a replacement for histopathological diagnosis. It is used for the molecular characterization of a diagnosed tumor or tumor material being evaluated.

13

Does the test guarantee successful treatment?

 

No. Altera™ provides molecular information that may help with treatment decisions, but response to treatment varies from patient to patient.

14

Who should interpret the results?

 

The report should be interpreted by the oncologist and relevant healthcare professionals, taking the patient's clinical situation into consideration.