Skip to main content
Premium Trial:

Request an Annual Quote

Celera Files for FDA OK for KIF6 Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Celera today said that it has filed for US Food and Drug Administration clearance to market its KIF6 Genotyping Assay.

The Alameda, Calif.-based firm filed the Premarket Approval Application for the test to run on Abbott's m2000 molecular diagnostics instrument system. Celera's Berkeley HeartLab business currently offers a KIF6 test in the US as a laboratory-developed test.

The KIF6 test is used to detect a variant in the KIF6 gene that the may be used in conjunction with clinical evaluation and patient assessment for identifying individuals at risk for coronary heart disease, and in patients for whom statin treatment is being considered.

In June 2010, Celera applied the CE Mark to the test allowing it to be marketed throughout the European Union and other countries that recognize the CE Mark. It followed that action in September with a license granted to Abbott to exclusively distribute the KIF6 test for use on the m2000 instrument system in those countries that recognize the CE Mark, but not in the US.

Celera noted that more than 870 of Abbott's m2000 systems have been placed in laboratories worldwide.

The Scan

Shape of Them All

According to BBC News, researchers have developed a protein structure database that includes much of the human proteome.

For Flu and More

The Wall Street Journal reports that several vaccine developers are working on mRNA-based vaccines for influenza.

To Boost Women

China's Ministry of Science and Technology aims to boost the number of female researchers through a new policy, reports the South China Morning Post.

Science Papers Describe Approach to Predict Chemotherapeutic Response, Role of Transcriptional Noise

In Science this week: neural network to predict chemotherapeutic response in cancer patients, and more.