Roche Wins FDA Nod for VENTANA ALK (D5F3) CDx Assay

November 7, 2017 |

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The VENTANA ALK (D5F3) CDx Assay is the only test FDA-approved as a companion diagnostic for ALECENSA.

Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for treatment with Roche’s ALECENSA (alectinib)

[07-November-2017]

TUCSON, Ariz., Nov. 7, 2017 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Roche medicine ALECENSA® (alectinib). The VENTANA ALK (D5F3) CDx Assay is the only test FDA-approved as a companion diagnostic for ALECENSA.

“We are very excited about the companion diagnostic label expansion for the ALK (D5F3) assay. This immunohistochemistry assay will deliver critical information on treatment options for non-small cell lung cancer patients,” said Ann Costello, Head of Roche Tissue Diagnostics. “The ability to identify ALK-positive patients very quickly with a simple IHC test ensures that more patients can benefit from targeted therapy.”

The VENTANA ALK (D5F3) CDx Assay has been shown in studies to identify more patients that will benefit from an anti-ALK target therapy than fluorescent in situ hybridization (FISH) testing.^3,4,5,6 The VENTANA ALK (D5F3) CDx Assay is available for use on the Roche BenchMark XT or BenchMark ULTRA IHC/ISH slide staining systems.⁷

About the VENTANA ALK (D5F3) CDx Assay
VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib) or ALECENSA® (alectinib).

This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.

This product is intended for in vitro diagnostic (IVD) use. For more information, visit ALKIHC.com.

About ALECENSA
For more information on ALECENSA (alectinib), visit www.alecensa.com.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare - a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry nine years in a row by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

VENTANA and BENCHMARK are trademarks of Roche. Other product names and trademarks are the property of their respective owners.

¹This product is intended for in vitro diagnostic (IVD) use.
²American Cancer Society.
Approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the advanced stages. Approximately 5 percent of people with NSCLC in the United States are ALK positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.
³van der Wekken AJ, Pelgrim R, ‘t Hart N, Werner N, Mastik MF, et al. Dichotomous. ALK-IHC is a better predictor for ALK inhibition outcome than traditional ALK-FISH in advanced non-small cell lung cancer. Clinical Cancer Research, 2017, 23(15):4251-4258. doi: 10.1158/1078-0432.CCR-16-1631.
⁴Zhou J, Zhao J, Sun K, Wang B, Wang L, et al. Accurate and economical detection of ALK positive lung Adenocarcinoma with semiquantitative immunohistochemical screening. PLoS ONE 2014, 9(3): e92828.doi:10.1371/journal.pone.0092828.
⁵Shan L, Lian F, Guo L, Yang X, Ying J, et al. Combination of conventional immunohistochemistry and qRT-PCR to detect ALK rearrangement. Diagnostic Pathology 2014, 9:3.doi:10.1186/1746-1596-9-3.
⁶Ying J, Guo L, Qiu T, Shan L, Ling Y, et al. Diagnostic value of a novel fully automated immunochemistry assay for detection of ALK rearrangement in primary lung adenocarcinoma. Annals of Oncology, 2013, 24(10):2589-2593; doi:10.1093/annonc/mdt295.
⁷The approved ALK (D5F3) Assay stained with OptiView DAB Detection and Amp is a 4 1/2-hour, fully automated test to be stained with all other routine IHC testing for same-day results and to meet current CAP/IASLC/AMP guidelines for testing patients with lung cancer; Lindeman NI, Cagle PT, Beasley MB, Chitale DA, Dacic S, et al. Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Journal of Thoracic Oncology 2013; 8(7):823-859. doi: 10.1097/JTO.0b013e318290868f.