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FDA Approves Agilent's Clone EP1

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Dako, an Agilent Technologies (A - Free Report) subsidiary, has received U.S. Food and Drug Administration (FDA) approval to sell its diagnostic tool Clone EP1 for the treatment of breast cancer in the U.S. market. The tool is already available in Europe.

The antibody named FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor alpha, Clone EP1, will help to get nearly accurate status of estrogen receptor (ER) in breast carcinomas, which is considered to be the most reliable factor to manage a patient's anti-hormonal therapy.

Clone EP1 was created by Epitomics Inc., the leader in rabbit monoclonal antibody (RabMAb) technology. Dako collaborated with Epitomics in 2011 to develop technologies in the field of anatomic pathology to detect and fight cancer. The company said that the new antibody will help physicians to provide the most effective treatment for a particular type of breast cancer.

Currently, the healthcare sector is witnessing a revolution and anatomic pathology tests are growing in popularity due to the valuable information they generate. The diagnosis in anatomic pathology is based on gross, microscopic, chemical, immunologic and molecular examination of organs, tissues and whole bodies (autopsy).

Agilent had acquired the Danish cancer diagnostics company Dako for $2.2 billion (on a debt-free basis) last year. Dako provides antibodies, scientific instruments and software mainly to cancer-related diagnostic labs and collaborates with drug companies for the development of methods to identify patients likely to benefit from certain therapies.

The company is continuously launching new tests and has collaborated with major companies to develop technologies in the field of anatomic pathology to fight cancer. Thus, with these collaborations and the FDA approval for its drugs, Dako may help Agilent tap the opportunity in the fast-growing healthcare diagnostics segment.

Agilent’s revenues in the first quarter were down sequentially but up 2.8% year over year to $1.68 billion. Revenue growth was greatly helped by the Dako acquisition. Earnings per share of 63 cents missed the Zacks Consensus Estimate by 4 cents or 6.0%.

Currently, Agilent has a Zacks Rank #3 (Hold). Other stocks that have been performing well and are worth considering include Intersil Corp (ISIL), Brocade Communications Systems (BRCD) and (PCLN), all carrying a Zacks Rank #2 (Buy).

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