|Filing confirms SQNM is moving forward with T21 test|
|By Staff and Wire Reports|
|Wednesday, 14 July 2010 07:54|
Sequenom Inc.(Nasdaq: SQNM) made an 8K filing which confirms SQNM is moving forward with the T21 test based on Dr. Dennis Lo's findings, which were outlined in Patrick Crutcher's earlier report.
"On May 6, 2010, we announced that we remained committed to the development, validation and launch of a noninvasive Trisomy 21 test and that following extensive scientific experimentation, we have decided to proceed with a purely DNA-based method for the detection of the Trisomy 21 aneuploidy using massively parallel sequencing instead of our proprietary MassARRAY platform. "
The presentation in Amsterdam should be the beginning of more public information about SQNM’s data. They should serve as a preliminary measure of how well the tests can perform in the field. Based on their most recent presentation, it appears everything is still on track for Laboratory Diagnostic Test(LDT) Launch upon validation study publication in Q4 2011.
Additionally, the 8K had great signs for those worried about another data debacle. They laid the groundwork to reinforce new ethics and protocols that are in effect.
Specifically, some of the key points addressed in the filing are:
● The introduction of a number of standard operating procedures regarding study design planning and review, including clear identification of whether a study is blinded or unblinded, raw data storage at multiple locations, independent third-party review of blinded clinical data, and a redundancy review of clinical study design by our oversight committee and of blinded clinical data by the science committee of our board of directors, our clinical group and our biostatistician;
● The creation of the science committee to oversee our research and development strategy and activities, including our evaluation of cross-functional training for personnel in all areas associated with research and development, covering: (i) the proper conduct of test studies, (ii) the proper and timely disclosure of any problems with test studies, and (iii) the proper handling of data and results of test studies;
● The formalization of the role of our oversight committee and the appointment of project leaders to oversee and manage each of our products in development;
● The revision of our policy concerning the storage of clinical samples, including requiring that samples be stored in third-party storage facilities, bar-coding samples for electronic tracking and auditing, creating formal procedures for obtaining a sample, and limiting access to our sample storage freezer;
● The requirement that the known outcomes of all samples to be used in any blinded experiment must be conveyed to the third party storage provider and are only revealed to us after the results of the blinded experiment have been finalized;
● The adoption of a comprehensive new policy on corporate disclosure controls and procedures, a set of disclosure controls and procedures and a corporate disclosure policy;
● The reduction in the number of direct reports to our Chief Executive Officer