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FDA Approves First Liquid Biopsy Test For Lung Cancer


FDA announced last week it has approved the first liquid biopsy test to detect a gene mutation associated with non-small cell lung cancer

Last week, FDA approved the first liquid biopsy test to approve a diagnostic for non-small lung cancer (NSCLC).

The test — cobas EGFR Mutation Test v2 — from Roche Diagnostics can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. The test is intended as a companion diagnostic test for cancer drug Tarceva.

Cancerous tumors may shed the tumor's DNA into the blood and this testing of tumor DNA is called liquid biopsy. This is a less invasive procedure compared with to surgical biopsy where a patient has to undergo a surgical procedure to remove a portion of suspected mass to allow for a confirmed diagnosis.

"Approvals of liquid biopsy tests make it possible to deliver highly individualized health care for patients,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Liquid biopsies also have the potential to allow physicians to identify patients whose tumors have specific mutations in the least invasive way possible.”

The cobas EGFR Mutation Test v2, looks at specific gene mutations and substitutions to determine whether NSCLC patients can benefit from the use of the Tarceva cancer drug made by Astellas Pharma Technologies and distributed by Genentech. The drug was approved in 2004 for locally advanced or metastatic NSCLC for patients who have not responded to at least one prior chemotherapy regimen. Then in 2013, the FDA approved the drug for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have certain EGFR properties as detected by an FDA-approved test. 

Liquid biopsy is gaining ground in the world of oncology. Several companies are developing or have developed approved these molecular diagnostic tests to be able to recommended cancer therapies that might have a better chance of working based on an individual patient's genetic mutations. Here are a few companies:

Foundation Medicine - Based in Cambridge, MA, the company recently launched the FoundationACT (Assay for Circulating Tumor DNA),a blood-based circulating tumor DNA (ctDNA) assay that provides a complete genomic picture when a tissue biopsy is not feasible or when the tumor tissue is unavailable. The company offers the tumor tissue analysis through other tests.

Pathway Genomics - The CancerIntercept Detect test from this San Diego company aims to detect "the presence of specific genomic markers called circulating tumor DNA (ctDNA) in 9 cancer driver genes," according to the company.

Grail - The San Francisco company was spun off from gene sequencing firm Illumina and aims to develop a pan cancer blood screening test to detect cancer in very early stages to improve the rate of cancer survival.

Trovagene - Based in San Diego, the company has developed an urine-based liquid biopsy test to detect and monitor cancer called Trovera. This approach removes the need to have repeated surgical biopsies.

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