Updated fertility blood test offers laboratories new option for measuring prolactin
Roche Diagnostics Elecsys® Prolactin II Assay enhances their comprehensive fertility menu

Roche Diagnostics today announced the availability of its new Elecsys Prolactin II assay for the in vitro quantitative determination of Prolactin, a hormone produced by the anterior pituitary gland, in human serum and plasma. The enhanced Prolactin II assay provides laboratories with an additional benchmark for macroprolactin recognition by using new antibodies with very low activity against most forms of macroprolactin. The target organ for Prolactin is the mammary gland, the development and differentiation of which is promoted by the hormone.

• High concentrations of Prolactin have an inhibiting action on the steriodogenesis (synthesis of steroids) of the ovaries and on hypophyseal gonadotropin (production of the gonads) production and secretion.

• During pregnancy the concentration of Prolactin rises under the influence of elevated estrogen and progesterone production. The stimulating action of prolactin on the mammary gland leads post partum to lactation.

• Hyperprolactinemia, or excess Prolactin, in men and women, is the main cause of fertility disorder. The amount of Prolactin in the blood is utilized in the diagnosis of anovular cycles (cycle without ovulation), hyperprolactinemic amenorrhea (abnormal absence or suppression of the menstrual discharge) and galactorrhea (spontaneous flow of milk from the nipple), gynecomastia (excessive development of the breast in the male) and azoospermia (devoid of sperm).

This new Prolactin assay has a low detection limit (less than 1 µIU/mL), a wide measuring range (1-10,000 µIU/mL), and excellent precision (Elecsys 2010 system total: less than or equal to 5%, MODULAR ANALYTICS E170 analyzer total: less than or equal to 2.0%).

The Elecsys Prolactin II assay expands Roche Diagnostics’ fertility/hormone menu which also includes HCG +ß, cortisol, estradiol, progesterone, testosterone, HCG, LH, FSH, DHEA-S, and SHBG.

The new Prolactin II assay is available for the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 immunoassay analyzers.

About Roche and the Roche Diagnostics Division
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004, the Pharmaceuticals Division generated 21.7 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

Roche’s Diagnostics Division, with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide.

Roche Diagnostics’ North American headquarters is located in Indianapolis, Ind. (www.roche-diagnostics.us) For further information, please visit our websites www.roche.us and www.roche-diagnostics.com

MODULAR and ELECSYS are trademarks of Roche.

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