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Agilent Gets Expanded FDA Approval for pharmDX Assay in U.S.

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Agilent Technologies, Inc. (A - Free Report) continues to gain traction in the medical diagnosis market on the back of advanced techniques, and robust clinical and diagnostic product portfolio.

Notably, Agilent has received FDA approval on expanded use of the company’s PD-L1 IHC 22C3 pharmDx assay.

Post the approval, Agilent can now use the assay as an aid for the identification of patients with triple-negative breast cancer (“TNBC”) for treatment with KEYTRUDA by leveraging combined positive score.

Notably, KEYTRUDA is an anti-PD-1 therapy. The therapy boosts the ability of the immune system to detect and fight tumor cells. PD-L1 IHC 22C3 pharmDx is the sole companion diagnostic, approved by FDA, which can be used for the treatment of TNBC patients with KEYTRUDA along with chemotherapy.

Growing Companion Diagnostics Market

Currently, the healthcare sector is witnessing a revolution. Companion diagnostics or personalized medicine is taking the center stage as it could provide improved patient care and better manage costs by administering the most appropriate treatment to individuals. It has been found that not all treatments are suitable for patients suffering from a specific disease as some require more specialized tests.

Agilent along with PD-L1 IHC 22C3’s strengthening detection capability of TNBC is likely to gain momentum in the global companion diagnostics market.

Per a report from MarketsandMarkets, the companion diagnostics market is expected to reach $6.8 billion by 2025 from $3.7 billion in 2020, at a CAGR of 12.9% from 2020 to 2025.

Notably, breast cancer is the most common type of cancer among women and the increasing occurrence of TNBC in such patients is boosting demand for companion diagnostics.

Moreover, high prevalence of such cases calls for these products that detect cancer during the early stages.

Bottom Line

Agilent’s expanding product portfolio and increased focus on segments with higher growth potential are key growth drivers. Growth in the pharmaceutical market on the back of solid momentum across both small and large molecule applications remains a positive.

Apart from the extended capability in TNBC cancer form, the product line is also helpful in the identification of non-small cell lung cancer, gastric or gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, cervical cancer, urothelial carcinoma, and head and neck squamous cell carcinoma patients for treatment with KEYTRUDA.

PD-L1 IHC 22C3 also identifies patients with non-small cell lung cancer for KEYTRUDA treatment by using tumor proportion score.

We believe the latest FDA approval will further help the company to cash in on the fast-growing healthcare companion diagnostics segment.

Zacks Rank

Currently, Agilent carries a Zacks Ranks #3 (Hold). Some better-ranked stocks in the broader technology sector include Marchex (MCHX - Free Report) , Overstock.com and Maxim Integrated Products, Inc. , each carrying a Zacks Rank #2 (Buy).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Long-term earnings growth for Marchex, Overstock.com, and Maxim is currently projected at 15%, 20% and 10%, respectively.

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