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News Breaks
June 16, 2014
08:05 EDTSQNMSequenom receives FDA premarket clearance
Sequenom announced that it has received premarket 510k clearance from the FDA to market its IMPACT Dx Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx System. The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed on the IMPACT Dx System, and is indicated for use as an aid in the diagnosis of patients with suspected thrombophilia. As previously announced, Sequenom completed the sale of its Bioscience business segment to Agena Bioscience. As part of this sale, the Premarket 510k Notification will transfer to Agena Bioscience and Sequenom will receive $2M upon the achievement of this regulatory milestone.
News For SQNM From The Last 14 Days
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September 22, 2014
07:05 EDTSQNMSequenom presents new data supporting accuracy of MaterniT21 test
Sequenom announced that its wholly owned subsidiary, Sequenom Laboratories, presented patient clinical data substantiating the performance of its MaterniT21 PLUS noninvasive prenatal test in the laboratory. An ad hoc analysis of 185,000 samples from patients at high-risk for fetal chromosome aneuploidy demonstrated stable positivity rates for trisomy 21, 18 and 13, which mirror the positivity rates found in large studies on high-risk populations utilizing invasive diagnostic procedures. Additionally, Sequenom Laboratories reported performance results from clinical testing with the MaterniT21 PLUS test with Enhanced Sequencing Series. In the ad hoc analysis based on voluntary outcomes provided by clinicians, the estimated sensitivity for trisomy 21, 18 and 13 were 99.3%, 98.3% and 97.4% respectively, and the estimated specificity was >99.9% for all three trisomies. These clinical laboratory performance data are equivalent to those published in the clinical validation studies of the MaterniT21 test. Based on these performance metrics, Sequenom Laboratories estimates that the MaterniT21 PLUS test positive predictive value for trisomy 21, 18 and 13 were 99.0%, 97.6% and 92.8% respectively, and the negative predictive value was >99.9% for all three trisomies.
September 17, 2014
11:57 EDTSQNMSequenom management to meet with Maxim
Meetings to be held in New York on September 22 with a group luncheon also and in Boston on September 23 hosted by Maxim.

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