Abbott Laboratories announced CE Marking (Conformité Européenne) for the ARCHITECT clinical chemistry Hemoglobin A1c (HbA1c) test, which may aid physicians in diagnosing and monitoring diabetes as well as identifying patients at risk for developing diabetes. The HbA1c test is a blood test that reflects a person's average blood glucose levels over the past three months. In 2009, an international expert committee recommended that physicians may use an HbA1c test for the diagnosis of type 2 diabetes and identification of patients at risk for developing diabetes if the assay meets specific performance criteria, such as certification and standardization processes outlined by the National Glycohemoglobin Standardization Program (NGSP) and the International Federation of Clinical Chemistry (IFCC). Diabetes can be managed by using diabetes medicines, making important lifestyle changes related to diet and exercise, and monitoring blood glucose and HbA1c levels.(2) For people whose HbA1c test results are normal, doctors may recommend that testing be repeated at least every three years or more frequently depending on a person's initial results and risk status.

Epizyme, Inc. announced that it has signed an agreement with Abbott Laboratories to develop a molecular companion diagnostic test for use with EPZ-5676. EPZ-5676, Epizyme's most advanced clinical product candidate, is an inhibitor targeting the DOT1L histone methyltransferase (HMT) for the treatment of mixed lineage leukemia (MLL-r), an aggressive genetically defined subtype of the two most common forms of acute leukemia, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). Under the agreement, Abbott will utilize its proprietary fluorescence in situ hybridization (FISH) technology to design a test to detect MLL genetic alterations that lead to the oncogenic (cancer causing) function of DOT1L. Epizyme will use Abbott's FISH-based test to help identify eligible patients for its DOT1L inhibitor.

Abbott Laboratories announced that the TECNIS(R) Toric 1-Piece intraocular lens (IOL) has received U.S. Food and Drug Administration (FDA) approval and is launching in the United States for the treatment of cataract patients with pre-existing corneal astigmatism. Corneal astigmatism is a condition where the curvature of the cornea is uneven, preventing light rays from focusing clearly on the retina, resulting in blurred vision. Intraocular lenses are implanted in a patient's eye after the removal of the natural lens that has become clouded by a cataract. Unlike conventional IOLs, the TECNIS Toric 1-Piece IOL can correct a patient's loss of focus due to pre-existing corneal astigmatism of one diopter (a unit of measurement of the refractive power of a lens) or greater. The average age for the cataract surgery patient in the United States is approximately 68 years with more than 3.5 million procedures performed annually. As the U.S. population continues to age, the number of cataract surgeries is expected to grow nearly 3% each year, increasing patient demand for improved, precise visual outcomes and independence from glasses. Along with delivering precise visual outcomes for patients, rotational stability is an important attribute of a toric IOL. The TECNIS Toric 1-piece IOL remains very stable once inserted into the eye, and meets the new standard for toric IOL rotational stability, as approved by the American National Standards Institute (ANSI). In addition to providing astigmatism correction, the TECNIS Toric 1-Piece lens minimizes imprecise light focusing (spherical aberration) to provide sharper distance vision for the patient.