Improving Outcomes for Patients with Advanced Cancers

This is a next-generation sequencing (NGS) blood-based test for patients with advanced-stage non-small cell lung, breast, colorectal, esophageal, gastric, gastroesophageal junction cancers, and melanoma. This test evaluates 33 genes for single nucleotide variants and insertions/deletions, eight genes for amplifications, and five genes associated with translocations (fusions). Additionally, the test also assesses for microsatellite instability (MSI).

There are several clinical scenarios to consider when ordering the Labcorp Plasma Focus test:

• Patient has a poor performance status, and obtaining a tissue biopsy is technically challenging or not safe
• Archived tumor tissue is exhausted, limited or not available
• The initial tumor biopsy was inadequate or contained insufficient tumor content
• Patient’s tumor is progressing on current therapy, and other therapeutic options are needed
• When rapid results are needed

A liquid biopsy test facilitates comprehensive genomic profiling from a simple blood draw for patients with advanced-stage cancers. Potential benefits of a liquid biopsy test include:

• Assessment of mutations that are present in the original tumor and/or sites of metastasis
• Assessment of mutations that may develop over time and after treatment
• Ability to perform testing during disease progression to identify resistance mutations to targeted therapy

The Labcorp Plasma Focus test should be considered a “rule-in” test instead of a “rule-out.” For example, if the test identifies a variant, we are confident that a specific alteration is present within the tumor. However, if a variant was not detected, it may be due to lack of circulating tumor DNA (ctDNA) shed into the bloodstream by the tumor. Tissue testing should be considered if a variant was not detected.  

The Labcorp Plasma Focus test detects 33 actionable genes for single nucleotide variants and insertions and deletions. Eight genes are evaluated for amplifications (EGFR, HER2, MET, MYC, FGFR2, KIT, CCND1, CD274). Five genes are evaluated for fusions (ALK, ROS1, FGFR2, NTRK1, RET). Microsatellite instability (MSI) is also included. The complete gene list is available on our website.

The Labcorp Plasma Focus liquid biopsy can diagnose microsatellite unstable tumors (MSI-H). However, a negative result does not entirely exclude the possibility of MSI-H status (because a negative result will occur in samples that lack ctDNA). 

For patients whose results are “MSI-not detected,” this could mean that circulating tumor DNA levels were below the threshold required for MSI-H detected or the tumor is microsatellite stable. To definitively diagnose microsatellite stable (MSS) tumors, tissue testing should be considered.

Using the Labcorp Oncology Liquid Biopsy kit, collect 20 mL of whole blood in two Streck Cell-Free DNA tubes. Write the appropriate patient information on the tube labels and tumor requisition form, include required documentation (i.e., a recent path report, medical notes and insurance information), and ship overnight to the testing laboratory, with provided packaging, within 24 hours of the blood draw. The specimen should be maintained at room temperature.  Blood samples must be received at the testing laboratory within 24 hours from the blood collection date in order to test. For questions, please contact 1-800-781-1259.

The shipping address for samples is:

PGDx*

3600 Boston Street
Suite 55
Baltimore MD 21224

If you do not have a Labcorp Oncology Liquid Biopsy kit, you may request one by calling 866-875-2271 or email [email protected].

*PGDx is a subsidiary of Laboratory Corporation of America Holdings, using the brand Labcorp

Patients with advanced stage or recurrent, refractory non-small cell lung, breast, colorectal, esophageal, gastric, gastroesophageal junction cancers and melanoma are eligible.

You will receive your patients’ results through your selected Labcorp report delivery method. Should you need a copy of a report, you are welcome to contact [email protected].

For clients with a Labcorp Link™ account, results will be sent through the web-based portal.  Other options include secure email or fax. Please note that a faxed version may be difficult to read. 

Yes. Labcorp Plasma Focus is run in a CLIA-certified and CAP-accredited lab.

You can contact our Client and Patient Resource team via email ([email protected]) or phone (1-800-781-1259).