Agilent’s cancer diagnostic kit gains EU approval for new uses

SANTA CLARA, Calif. - Agilent Technologies Inc. (NYSE: A) has announced that its PD-L1 IHC 28-8 pharmDx kit has obtained two new companion diagnostic indications approvals in the European Union, enhancing treatment options for patients with early-stage non-small cell lung cancer (NSCLC) and previously untreated advanced melanoma. These approvals expand the kit’s indications in Europe to nine. The announcement comes as Agilent maintains strong financial performance, with a robust gross profit margin of 54% and annual revenue of $6.5 billion. According to InvestingPro data, the company’s financial health score is rated as GOOD, supported by strong cash flows and moderate debt levels.

The PD-L1 IHC 28-8 pharmDx, designed for use with Agilent’s Autostainer Link 48, is the only clinically validated test to identify patients eligible for certain anti-PD-1 therapies. For resectable NSCLC patients with PD-L1 expression of 1% or more and at high risk of recurrence, the test can now be used to qualify them for treatment with Bristol Myers Squibb’s OPDIVO® (nivolumab) in combination with platinum-based chemotherapy. Additionally, it can determine eligibility for Bristol Myers Squibb’s Opdualag™ (nivolumab and relatlimab) in patients aged 12 and over with tumor cell PD-L1 expression less than 1% who have previously untreated advanced melanoma.

The significance of these approvals lies in the critical role of PD-L1 as a biomarker for predicting the potential response to anti-PD-1 therapies, which are transforming cancer treatment. Pathology labs are instrumental in informing treatment decisions by determining PD-L1 expression levels.

Agilent’s commitment to the development of companion diagnostics is reinforced by the IVDR compliance certification, which assures patients and healthcare professionals in the EU of the reliability of these medical devices within the diagnostic process.

Simon May, senior vice president of Agilent’s Life Sciences and Diagnostics Markets Group, emphasized the importance of the new indications, stating that they provide physicians with crucial information for making informed treatment decisions for common and potentially deadly cancers.

This development is based on a press release statement and underscores Agilent’s ongoing contribution to companion diagnostics, a field where the company has over 50 years of experience and a history of pioneering FDA-approved companion diagnostic products. The company’s strong market position is reflected in its financial stability, with $1.3 billion in levered free cash flow and a healthy current ratio of 2.2, indicating solid operational efficiency and financial management.

In other recent news, Agilent Technologies reported its first-quarter 2025 earnings, surpassing Wall Street expectations. The company achieved an earnings per share (EPS) of $1.31, exceeding the forecast of $1.27, and generated revenue of $1.68 billion, slightly above the anticipated $1.67 billion. Despite the positive earnings report, Agilent’s stock experienced a decline in aftermarket trading. The company’s performance was bolstered by strong growth in PFAS testing and food markets, although the pharma market remained flat globally. Agilent’s full-year EPS guidance is set between $5.54 and $5.61, with core revenue growth expected to range from 2.5% to 3.5%.

In other developments, Stifel analysts have maintained a Buy rating for Agilent, setting a price target of $151.00. They noted that Agilent’s first-quarter performance slightly exceeded consensus estimates on both revenue and earnings. Although the outlook for the second quarter appears softer, Agilent’s full-year guidance remains unchanged, indicating confidence in achieving its growth targets. The company continues to benefit from increased pharmaceutical activity and some stimulus in China, which have helped offset softer demand from U.S. academic institutions. Agilent’s recent product launches, particularly in liquid chromatography, are gaining traction, contributing to the company’s favorable market position.

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