FDA Approves First Liquid Biopsy Test for Lung Cancer Patients

On June 1, the U.S. Food and Drug Administration (FDA) approved a liquid biopsy test, a companion diagnostic test called cobas EGFR Mutation Test v2. The test uses plasma samples to identify patients with metastatic non-small cell lung cancer (NSCLC) eligible for treatment with the EGFR-targeted therapeutic erlotinib (Tarceva).

The test detects specific alterations in the gene epidermal growth factor receptor (EGFR): exon 19 deletions or exon 21 (L858R) substitution mutations. These mutations are present in about 10 to 20 percent of NSCLCs, the most common type of lung cancer.

This is the first liquid biopsy test approved for use by the FDA.

Read more: FDA Approves First Liquid Biopsy Test for Lung Cancer Patients

Source: aacr

Rising Liquid Biopsy Tide Lifts Cancer Dx

Traditional Tissue Biopsies Are Not Providing the Type of Real-Time Monitoring Necessary for Effectively Catching Relapse

As molecular diagnostics for oncology shifts into clinical practice, efforts have not only focused on genotyping patient-specific tumors to initiate targeted therapies, but on early detection, availability, improved quality control, and refined workflow.

One major push, that exemplifies the concomitance of these trends, has been the rise of the less-invasive and more cost-effective liquid sampling for cancer diagnosis; sometimes called a liquid biopsy.

Read more: Rising Liquid Biopsy Tide Lifts Cancer Dx

The FDA recently approved Hologic’s prostate cancer test, which improves upon the less sensitive
and less specific standard PSA tests via examination of the PCA3 gene in urine.

Source: genengnews