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FDA Clears Dako's Companion Dx for Herceptin

NEW YORK (GenomeWeb News) – The US Food and Drug Administration late last month approved a Dako test for use as a companion diagnostic for determining which patients may benefit from treatment with Herceptin (trastuzumab).

The Danish cancer diagnostic firm's HER2 CISH pharmDx Kit measures copies of the HER2 gene in formalin-fixed, paraffin-embedded breast cancer tissue specimens by using a chromogenic in situ method, and results "are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients," FDA said in its approval letter to Dako.

The CISH procedure is automated on Dako's Autostainer instruments.

During the summer, FDA cleared a test made by Ventana Medical Systems, part of the Roche Group, which measures the number copies of the HER2 gene for use as a tool to determine patients who may be candidates for Herceptin, manufactured by Genentech, also a Roche company.

Dako's HercepTest and Her2 FISH pharmDx were approved by FDA last year to guide treatment of patients with Herceptin in combination with chemotherapy for HER2-positive metastatic cancer of the stomach or gastroesophageal junction in men and women who have not received prior medicines for their metastatic disease.

The Scan

Unwrapping Mummies' Faces

LiveScience reports that Parabon NanoLabs researchers have reconstructed how three Egyptian mummies may have looked.

Study on Hold

The Spectrum 10K study has been put on hold due to a backlash, leading the researchers to conduct consultations with the autism community, Nature News reports.

Others Out There Already

Reuters reports that Sanofi is no longer developing an mRNA-based vaccine for SARS-CoV-2.

PNAS Papers on GWAS False Discovery, PRAMEF2 Role in Tumorigenesis, RNA Virus Reverse Genetics

In PNAS this week: strategy to account for GWAS false-discovery rates, role of PRAMEF2 in cancer development, and more.