AUG 22, 2018 9:43 PM PDT

New Clinical Assay Useful For Urothelial Cancer

WRITTEN BY: Nouran Amin

U.S. Food and Drug Administration (FDA) has now approved a pharmDx assay called ‘Dako PD-L1 IHC 22C3’ by Agilent Technologies Inc. for use in urothelial carcinoma. The assay is the only approved companion diagnostic to help identify patients with urothelial carcinoma for treatment with KEYTRUDA, which is a monoclonal anti-PD1 therapy manufactured by the pharmaceutical company known Merck for the first-line treatment option of cancer.

Specifically, KEYTRUDA is approved for cancer patients experiencing locally advanced or metastatic urothelial carcinoma and who are not eligible for cisplatin-containing chemotherapy. Additionally, their tumors must express PD-L1 [Combined Positive Score (CPS) ≥ 10] as determined through an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy.

The pharmDx assay referred to as ‘PD-L1 IHC 22C3’ follows previous FDA-approved assay for non-small cell lung cancer (NSCLC), gastric or gastroesophageal junction (GEJ) adenocarcinoma, and cervical cancer. "Anti-PD-1 therapies are a promising treatment class for many cancer types, and early PD-L1 testing can provide critical information to physicians managing urothelial carcinoma patients," explains Sam Raha, the president of Agilent's Diagnostics and Genomics Group. "By expanding the use of PD-L1 IHC 22C3 pharmDx, Agilent strives to address the unmet need for treatment options in patients who are ineligible for cisplatin-containing chemotherapy. Through these efforts, we maintain our commitment to bringing companion diagnostics to the market in support of groundbreaking immuno-oncology therapeutics."

The 5th most common cancer in the United States, urothelial carcinoma holds an estimated incidence of 81,000 new diagnoses in just 2018. For 30 years, cancer-related morality has not approved for patients with advanced/metastatic urothelial carcinoma with a five-year survival rate of approximately 15%. Additionally, the age along with disease-associated comorbidities affect patient eligibility for standard treatments such as cisplatin-containing chemotherapy. Patients that cannot be administered cisplatin-containing chemotherapy, will have an unmet need for effective therapy.

Source: Agilent

About the Author
  • Nouran earned her BS and MS in Biology at IUPUI and currently shares her love of science by teaching. She enjoys writing on various topics as well including science & medicine, global health, and conservation biology. She hopes through her writing she can make science more engaging and communicable to the general public.
You May Also Like
NOV 25, 2019
Clinical & Molecular DX
NOV 25, 2019
eRapid: molecular diagnostic power in the palm of your hand
We've heard lofty biotech promises in the news of being able to diagnose diseases from a single drop of blood. Yet, diag ...
DEC 04, 2019
Clinical & Molecular DX
DEC 04, 2019
Genetic platform takes the guesswork out of catching infections
A physician is faced with 3 patients: an elderly person with a chronic cough, a child being wheeled out of surgery and a ...
DEC 05, 2019
Clinical & Molecular DX
DEC 05, 2019
Catching drug-resistant HIV mutants with next generation sequencing
Human immunodeficiency virus (HIV)-positive individuals are treated with antiretroviral therapies to reduce the amount o ...
MAR 29, 2020
Genetics & Genomics
MAR 29, 2020
Biomarkers That Predict Crohn's Disease Are Identified
A series of studies published in Gastroenterology has outlined new approaches in predicting IBD.
APR 08, 2020
Technology
APR 08, 2020
Can Quantum Technology Diagnose Complicated Heart Conditions?
Currently, atrial fibrillation (AF) is a heart condition that is diagnosed using an electrocardiogram (ECG). However, di ...
MAY 21, 2020
Clinical & Molecular DX
MAY 21, 2020
Taking the Guesswork out of Fat Consumption
  When it comes to healthy eating, we often receive mixed messages. Low fat diets that have been popularized for de ...
Loading Comments...