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Agilent Announces Receipt of FDA Approval for pharmDX Assay

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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 as well as robust clinical and diagnostic product portfolio.

This is evident from the latest achievement of its pharmDX product line, which is categorized under the immunohistochemistry product portfolio.

We note that the FDA has forwarded its approval on the expanded use of the company’s PD-L1 IHC 22C3 pharmDx assay. The assay was developed in collaboration with Merck & Co (MRK - Free Report) .

Post the approval, Agilent will be aiding the identification of patients with head and neck squamous cell carcinoma (“HNSCC”) for treatment with KEYTRUDA by leveraging combined positive score.

Notably, KEYTRUDA is a humanized monoclonal therapy, which has been developed by Merck. The therapy boosts the ability of the immune system to detect and fight tumor cells. PD-L1 IHC 22C3 is KEYTRUDA’s sole companion immunotherapeutic diagnostic.

Growing Immunohistochemistry Space

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

Per a report from Grand View Research, the market is expected to reach $3.1 billion by 2025 at a CAGR of 8.8% from 2018 to 2025.

Further, a report from Acumen Research and Consulting suggests that the market is anticipated to hit $3.7 billion by 2026 at a CAGR of 8.5% from 2018 and 2026.

Additionally, increasing occurrence of HNSCC, which represents 90% of the head and neck cancer cases in the world and ranks seventh in the most common cancer type, is boosting demand for immunohistochemistry products.

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

Agilent Well Placed

We believe that Agilent is well poised to benefit from the potential Immunohistochemistry market on the back of robust PD-L1 IHC 22C3 and the recent FDA approval.

Apart from the extended capability in HNSCC cancer form, the product line is also helpful in the identification of urothelial carcinoma, cervical cancer and gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA with the aid of combined positive score.

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

Apart from the above mentioned qualities and features of PD-L1 IHC 22C3, other immunochemistry products related to atomic absorption, cell analysis, biomolecule synthesis and purification, capillary electrophoresis and molecular pathology are likely to strengthen its position in the market.

Zacks Rank & Stocks to Consider

Currently, Agilent carries a Zacks Ranks #3 (Hold).

Some better-ranked stocks in the broader technology sector are Itron, Inc (ITRI - Free Report) and AMETEK, Inc (AME - Free Report) , both of which carry 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 rate for Itron and AMETEK is currently pegged at 25% and 25%, respectively.

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