The United States of America, As Represented by the Secretary, Department of Health and Human Services

Emory University

Miao He

William A Gahl

Marjan Huizing

Xueli Li

Rong Jiang

Nuria Carrillo-Carrasco

Methods are disclosed for diagnosing a hyposialylation disorder. Methods are also disclosed for determining the effectiveness of a therapeutic agent for treatment of a hyposialylation disorder in a subject. These methods include measuring an amount of monosialylated Thomsen-Friedenreich (ST) antigen and measuring an amount of non-sialylated Thomsen-Friedenreich antigen (T) in a biological sample, such as a serum or plasma sample from the subject and determining the ratio of T to ST. A ratio of T to monosialylated ST of about 0.06 or higher diagnoses the hyposialylation disorder or indicates that the therapeutic agent is not effective for the treatment of the hyposialylation disorder. In other embodiments, a ratio of T to ST less than about 0.06 indicates that the therapeutic agent is effective for the treatment of the hyposialylation disorder, or the subject does not have the hyposialylation disorder. In additional embodiments, these methods can be used to determine the lowest effective dosage of the therapeutic agent of use to treat the subject.

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Alpharetta, GA, United States of America

Miao He