publication date: Jul. 15, 2016

Drugs and Targets

FDA Approves Cobas HPV Test With BD SurePath Specimen Vial

 

FDA approved performing the Roche cobas HPV Test from cervical specimens collected in BD SurePath Preservative Fluid using the BD SurePath vial.

In the U.S., a significant number of cervical cancer screening samples are processed using the SurePath vial and preservative fluid, according to Roche. The cobas test is the first HPV test approved by the FDA for use with the SurePath collection medium and vial for processing cervical cancer screening samples.

The cobas HPV Test, when used with samples collected into SurePath Preservative Fluid, was demonstrated to be safe and effective for cervical cancer screening. The test demonstrated comparable performance similar to specimens collected into ThinPrep PreservCyt Solution.

 

Health Canada approved Tagrisso (osimertinib) for patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer who have progressed on or after EGFR tyrosine kinase inhibitor therapy.

Tagrisso, sponsored by AstraZeneca Canada, was granted Notice of Compliance with Conditions, based on promising evidence of clinical efficacy data, pending the results of additional trials to verify its clinical benefit.

Tagrisso is the first and only approved medicine indicated for patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, according to AstraZeneca. Tagrisso is an EGFR-TKI that acts on both the sensitizing EGFR mutation involved in cancer development and T790M, a genetic mutation that makes tumors resistant to existing treatment with EGFR-TKIs. This advancement in therapy allows patients to remain on an oral EGFR-TKI medication longer, delaying the need for chemotherapy.

 

FDA granted a Rare Pediatric Disease Designation to ABT-414, an investigational antibody drug conjugate targeting the epidermal growth factor receptor for the treatment … Continue reading 42-28 Drugs and Targets: FDA Approves Cobas HPV Test With BD SurePath Specimen Vial

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