"Quality Stocks" on Avant ... "Avant has been e
Post# of 30028
Posted On: 01/26/2016 1:37:21 PM
"Quality Stocks" on Avant ...
"Avant has been engaged in the calibration testing and validation study phases regarding OvaDx and it expects the 510K trials to commence this year. In September 2015, Avant began calibration testing in preparation for the validation study of OvaDx, which will be used to support a pre-Submission package to the United States Food and Drug Administration (FDA).
Upon completion of the calibration testing, Avant plans to test the previously purchased set of ovarian cancer specimens, including serial sets obtained from women diagnosed previously with ovarian cancer. The tests on the ovarian cancer specimens will serve as the validation study and form the basis of the pre-Submission package delivered to the FDA for review and comment prior to the commencement of the OvaDx 510(k) trial.
The OvaDx microarray test is intended for use as an aid in monitoring women diagnosed previously with ovarian cancer. The validation study and 510(k) trial will be conducted in a double-blinded environment supervised by DOCRO, Inc., an independent clinical research organization. In a double-blinded environment, neither the researchers nor the subjects participating have knowledge of whether a procedure administered is an actual test or simply a control.
The results from the validation study are expected to be published in a peer-reviewed scientific journal within six months of test completion and data analysis. 510K trials will commence after the validation study is completed. A 510(K) is a pre-market submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device. Avant believes the OvaDx test has an advantage over Roche’s CA-125 test and Vermillion’s Ova 1 test.
In October 2015, Avant received notification, through its independent clinical research organization, DOCRO, that the previously purchased specimens have been approved and are available for use in the validation study."
"Avant has been engaged in the calibration testing and validation study phases regarding OvaDx and it expects the 510K trials to commence this year. In September 2015, Avant began calibration testing in preparation for the validation study of OvaDx, which will be used to support a pre-Submission package to the United States Food and Drug Administration (FDA).
Upon completion of the calibration testing, Avant plans to test the previously purchased set of ovarian cancer specimens, including serial sets obtained from women diagnosed previously with ovarian cancer. The tests on the ovarian cancer specimens will serve as the validation study and form the basis of the pre-Submission package delivered to the FDA for review and comment prior to the commencement of the OvaDx 510(k) trial.
The OvaDx microarray test is intended for use as an aid in monitoring women diagnosed previously with ovarian cancer. The validation study and 510(k) trial will be conducted in a double-blinded environment supervised by DOCRO, Inc., an independent clinical research organization. In a double-blinded environment, neither the researchers nor the subjects participating have knowledge of whether a procedure administered is an actual test or simply a control.
The results from the validation study are expected to be published in a peer-reviewed scientific journal within six months of test completion and data analysis. 510K trials will commence after the validation study is completed. A 510(K) is a pre-market submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device. Avant believes the OvaDx test has an advantage over Roche’s CA-125 test and Vermillion’s Ova 1 test.
In October 2015, Avant received notification, through its independent clinical research organization, DOCRO, that the previously purchased specimens have been approved and are available for use in the validation study."
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