An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
Agilent Companion Diagnostic Expands CE-IVD Mark for PD-L1 IHC 28-8 pharmDx to Include Esophageal Squamous Cell Carcinoma
Rhea-AI Impact
(Low)
Rhea-AI Sentiment
(Neutral)
Tags
Rhea-AI Summary
Agilent Technologies Inc. (NYSE: A) announced expanded CE-IVD marking in the EU for its PD-L1 IHC 28-8 pharmDx, aiding in identifying esophageal squamous cell carcinoma patients for treatment with OPDIVO® (nivolumab) alongside chemotherapy or YERVOY® (ipilimumab). Esophageal cancer, the seventh most common globally, had about 600,000 new cases in 2020. This advancement marks a significant step in providing targeted immunotherapy options, promising improved survival rates for patients.
Positive
Expanded CE-IVD marking for PD-L1 IHC 28-8 pharmDx enhances diagnostic capabilities in Europe.
New treatment options for patients with esophageal squamous cell carcinoma, potentially improving overall survival rates.
Negative
None.
SANTA CLARA, Calif.--(BUSINESS WIRE)--
Agilent Technologies Inc. (NYSE: A) today announced it has expanded CE-IVD marking in the European Union for its PD-L1 IHC 28-8 pharmDx as an aid in identifying esophageal squamous cell carcinoma patients for treatment with Bristol Myers Squibb’s PD-1-targeted immunotherapeutic OPDIVO® (nivolumab), in combination with fluoropyrimidine and platinum-based chemotherapy or OPDIVO® in combination with YERVOY® (ipilimumab). These combined treatments provide new hope for patients diagnosed with these cancers.
Esophageal cancer is the seventh most common cancer and the sixth leading cause of death from cancer worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. The two most common types of esophageal cancer are squamous cell carcinoma and adenocarcinoma, which account for approximately 85% and 15% of all esophageal cancers, respectively, though esophageal tumor histology can vary by region and country.
PD-L1 is a critical biomarker for response to anti-PD-1 therapies, including the immunotherapeutic agent OPDIVO® based on the Phase 3 CheckMate-648 trial results. When used in conjunction with PD-L1 IHC 28-8 pharmDx as a companion test, first-line treatment with OPDIVO® in combination with chemotherapy or in combination with YERVOY® provides PD-1-directed treatment to demonstrate superior overall survival when compared to chemotherapy alone in patients with unresectable advanced, recurrent, or metastatic previously untreated esophageal squamous cell carcinoma with tumor cell PD-L1 expression ≥ 1%.
“With the CE marking of expanded use in Europe of our PD-L1 IHC 28-8 pharmDx assay, Agilent enables pathologists the increased capability to identify patients with ESCC for first-line treatment with OPDIVO® in combination with chemotherapy or YERVOY® (ipilimumab)," said Sam Raha, president of Agilent's Diagnostics and Genomics Group. “We greatly value our relationship with Bristol Myers Squibb, and are committed to continuing developing and commercializing market-leading companion diagnostic products.”
Agilent is the worldwide leader in partnering with pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy. With the expansion of PD-L1 IHC 28-8 pharmDx, Agilent continues to set the standard and lead with innovation, quality, and ease of implementation—furthering their ongoing commitment to fight cancer and enable new discoveries.
References
1. Bray, F.; Ferlay, J.; Soerjomataram, I.; Siegel, R.; Torre, L.; Jemal, A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA A Cancer J. Clin. 2018, 68, 394–424. https://doi.org/10.3322/caac.21492
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, please subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.
What is the significance of Agilent's expanded CE-IVD marking for PD-L1 IHC 28-8?
The expanded CE-IVD marking allows for improved identification of esophageal squamous cell carcinoma patients eligible for treatment, enhancing patient care.
How does the PD-L1 IHC 28-8 pharmDx aid in cancer treatment?
It serves as a companion diagnostic test to identify patients who may benefit from OPDIVO® treatment, increasing the chances of better outcomes.
Why is esophageal cancer highlighted in Agilent's press release?
Esophageal cancer is a major health concern, ranking as the seventh most common cancer globally, prompting the development of targeted treatments.
What is the relation between Agilent and Bristol Myers Squibb?
Agilent collaborates with Bristol Myers Squibb to develop market-leading companion diagnostics for targeted cancer therapies.
What financial impact does the PD-L1 IHC 28-8 expansion have on Agilent?
While specific financial impacts are not mentioned, the expansion may lead to increased sales and market share in the diagnostics sector.
