FDA Approves Trastuzumab Companion Diagnostic for Detection of HER2 in Breast Cancer

July 30, 2020

The FDA has approved the Ventana HER2 Dual ISH DNA Probe Cocktail assay as a companion diagnostic for trastuzumab and for the detection of the HER2 biomarker in patients with breast cancer.

The FDA has approved the Ventana HER2 Dual ISH DNA Probe Cocktail assay as a companion diagnostic for trastuzumab (Herceptin) and for the detection of the HER2 biomarker in patients with breast cancer, Roche announced.1

The assay was designed for a same-day turnaround of results, allowing for faster access to results for clinicians than other forms of testing for HER2.

“With this new Ventana HER2 Dual ISH assay, Roche continues to deliver on its commitment to advance personalized healthcare,” said Thomas Schinecker, CEO of Roche Diagnostics, in a press release. “Quick test results are crucial in the fight against cancer and by delivering critical information on treatment options for breast cancer patients faster, this assay will aid clinicians in their therapeutic decisions.”

Approximately 15% to 20% of cases of breast cancer overexpress HER2 and would be eligible for treatment with HER2-targeted therapy, such as trastuzumab. Use of the companion diagnostic would enable the identification of patients with HER2-positive breast cancer who may be likely to benefit from trastuzumab therapy.

With the assay, HER2 gene status is determined on formalin-fixed, paraffin-embedded human breast tissue specimens through enumeration of the ratio of HER2 gene to chromosome 17 through light microscopy.2

The Ventana HER2 Dual ISH assay has been enhanced from earlier generation tests to include new oligonucleotide probes and highly sensitive detection kits. This assay is able to be used with the Ventana Silver ISH DNP Detection Kit as well as the Ventana Red ISH DIG Detection Kit and is interpreted using brightfield microscopy so that a specialized fluorescence microscope is not necessary.

The assay is highly concordant with fluorescence in situ hybridization findings and the results are highly reproducible between laboratories and pathologies.

In April 2019 the Ventana HER2 Dual ISH assay was launched as a CE in vitro diagnostic medical device for the detection of HER2 in patients with breast and gastric cancers in Europe, the Middle East, Africa, Latin America, and Asia Pacific.3

References:

FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy. News release. Roche. July 29, 2020. Accessed July 30, 2020. https://bit.ly/2PahDgx

VENTANA HER2 Dual ISH DNA Probe Cocktail assay (CE IVD). Roche Diagnostics. Accessed July 30, 2020. https://bit.ly/3jVH83q

Roche launches new VENTANA HER2 Dual ISH companion diagnostic test for breast and gastric cancer patients eligible for targeted therapy. News release. Roche. April 23, 2019. Accessed July 30, 2020. https://bit.ly/3hNF0Jd