About the Oncotype MAPTM Pan-Cancer Tissue Test for Pathology

Accurate insights from samples as small as a grain of rice*

Comprehensive characterization of tissue samples is crucial to getting a precise diagnosis and deciding on the best treatment plan. With the rise of precision oncology, genomic profiling is playing an increasingly large role in diagnosis and clinical decision-making. Utilizing next generation sequencing (NGS) and tumor specific immunohistochemical (IHC) panels, the Oncotype MAP Pan-Cancer Tissue test augments the power of your lab by identifying clinically relevant genomic alterations from patient specimens as small as 3 mm2 of tissue* with 15% tumor content within 3-5 business days*†.

Why Choose the Oncotype MAP Pan-Cancer Tissue Test?

Pathologists have always had the challenge of answering many questions from a single sample as quickly as possible. The Oncotype MAP test meets pathologists’ needs by providing accurate* answers, from small sample sizes in a timely manner. Worried about quantity not sufficient (QNS)? With the Oncotype MAP test, cases that do not meet acceptance criteria are typically notified in as few as 2 business days* to request additional tissue. The test can be performed on any FFPE sample including:

  • Archival tissue
  • Core biopsies
  • Fine needle aspirate cell blocks
  • Body fluid cell blocks
  • Bone metastases

FAST

icon fast

  •   Results in 3-5 business days*
  •   Quantity Not Sufficient (QNS) results in as few as 2 business days

COMPREHENSIVE

icon comprehensive

  • >250 genes, 12 fusions/structural variants
  •   24 IHC stains
  •   30+ tumor-specific panels
  •   Copy number variants
  •   Tumor mutational burden

ACTIONABLE

icon actionable

Test assesses:
  •   100+ therapies
  •   45+ combination therapies
  •   650+ clinical trials

ACCURATE

icon accurate

  • >99% sensitivity and specificity§ on small samples
  • Low QNS* rate
  • Compatible with small fine needle aspirates and tissues
  •   FFPE samples as small as 3mm2* about the size of a grain of rice


An Extension of Your Pathology Lab

With over 250 genes, 12 structural variants/fusions, 24 IHC stains, copy number variants and assessment of tumor mutational burden, the comprehensive Oncotype MAP Pan-Cancer Tissue test augments the results you’ve generated, confirming your diagnosis and leveraging NCCN®, CAP, and ASCO# recommendations to identify evidence-based, genome-informed therapies and clinical trials.

Patient Eligibility

The Oncotype MAP Pan-Cancer Tissue test is most appropriate for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. The test can also provide valuable data and analysis to inform treatment decisions where no standard of care exists.

Guidance for Sample Submission

The Oncotype MAP Pan-Cancer Tissue test can be run on samples as small as 3 mm2 with 15% tumor content, but larger samples (≥10 mm2) with higher tumor content (≥20%) are preferred, when available. For tissue blocks where the overall tumor content does not meet criteria, microdissection will be performed, if possible.

To reduce delays in testing and subsequent treatment, we recommend that a pathologist select the optimal block for testing. Please reference our sample submission guidelines and choose the formalin-fixed, paraffin-embedded (FFPE) block with the greatest amount/area of the highest-grade carcinoma, morphologically consistent with the submitting diagnosis. EDTA should be used for samples requiring decalcification to preserve nucleic acid and protein expression.

MAP Submission Guidelines

* In cases where the tumor percent is less than 20% after macrodissection, we need an additional 4 slides for MMR IHC
** Negative reagent control (NRC) slide required for PD-L1 (SP142) IHC
† For cases where slides are submitted, additional levels or a tissue block may be requested to perform microdissection.
If HER2 equivocal, send 5 additional slides for FISH.

How to Interpret the Results

The easy-to-interpret report includes NCCN actionable indications for therapy based on the individual patient’s IHC results and genomic findings.

Questions? Get in touch today!

REFERENCES

*Data on file.
† Turnaround time is based on qualified sample receipt. Data on file.
‡ Bone samples should be decalcified with EDTA solution according to bone decalcification protocol.
§ >99% sensitivity for SNVs and Indels. Detection down to ≥7.5% mutant allele frequency (MAF) with >99% specificity. Data on file.

¶NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

CAP Guidelines: https://www.cap.org/protocols-and-guidelines/current-cap-guidelines

#American Society of Clinical Oncology (ASCO) and ASCO are registered trademarks of ASCO; ASCO does not endorse any product or therapy.

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.4.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed May 6, 2021. To view the most recent and complete version of the guideline, go online to www.nccn.org/guidelines/.

Making cancer care smarter.®