Roche Liquid Biopsy for Lung Cancer Garners FDA Approval

The Food and Drug Administration (FDA) has approved the first blood-based genetic test capable of detecting epidermal growth factor receptor (EGFR) gene mutations in patients with non-small cell lung cancer (NSCLC). NSCLC accounts for approximately 80%–85% of lung cancers, according to the American Cancer Society. Roche Molecular Systems developed the cobas EGFR Mutation test v2 as a companion diagnostic for Tarceva (erlotinib), a drug manufactured by Astellas Pharma Technologies for managing NSCLC in various treatment stages.

From sample collection to automated result interpretation, testing takes no more than 8 hours, according to Roche. The liquid biopsy identifies 42 mutations in exons 18, 19, 20, and 21 of the EGFR gene, including exon 19 deletion and L858R substitution mutations. This can help clinicians identify which patients would benefit from Tarceva, which FDA approved in 2013 for patients with NSCLC tumors exhibiting either the EGFR exon 19 deletion or L858R substitution mutations.

To test the accuracy of the cobas EGFR Mutation test v2, researchers compared the liquid biopsy results with the test results of patients who were identified as positive for the exon 19 or L858R mutations with the cobas EGFR Mutation Test v1, which uses a tumor biopsy sample.

In addition to identifying prospective Tarceva candidates, the cobas EGFR mutation test v2 might serve as an alternative for patients too ill to undergo a tumor biopsy. The cobas EGFR mutation test v2 can also be used with formalin-fixed paraffin-embedded tumor tissue in addition to plasma.

Hologic Zika Test Receives Emergency Use Authorization From FDA

The Food and Drug Administration (FDA) has granted an emergency use authorization to Hologic for the company’s new test for Zika virus infection, the Aptima Zika virus assay. This test qualitatively detects RNA from the Zika virus in human serum and plasma specimens. It runs on the Hologic Panther system, an integrated platform that fully automates all aspects of nucleic acid amplification testing, and is designed for use in individuals with symptoms of Zika virus infection and/or who meet the Zika virus epidemiological criteria established by the Centers for Disease Control and Prevention. The Aptima Zika virus assay will be available for use in all 50 states, Puerto Rico, and U.S. territories, thereby expanding the number of public and private labs that can test for the virus.

FDA Gives Nod to Meridian Bioscience for Pneumonia Assay

Meridian Bioscience has received Food and Drug Administration (FDA) clearance for the illumigene Mycoplasma Direct assay, a new molecular test for Mycoplasma pneumoniae. Due to Mycoplasma’s lack of a cell wall, typical antibiotics like penicillin and cephalosporin are not effective. With the Mycoplasma Direct assay, Meridian aims to reduce the use of broad-spectrum antibiotics by enabling healthcare providers to detect M. pneumoniae infection on the first day of symptoms. The illumigene Mycoplasma Direct assay, launched earlier this year in Europe, is designed for use with throat swabs and involves a 3-step procedure that requires less than 2 minutes of hands-on time and provides results in less than 1 hour. Meridian hopes that this test will improve on traditional methods for diagnosing M. pneumoniae infection such as serology and X-ray, whose sensitivities might be as low as 25% and 41%, respectively.