Avant Diagnostics Inc fka AVDX

[MikeCr]

Back in January Quality Stocks also published a correction about the "510K trials". Why are they using the old wording again today?

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=119986655

Thursday, 01/21/16
Avant Diagnostics (AVDX): Trials and Tribulations

Recently, in Avant Diagnostics set to exploit new opportunities in the laboratory testing market (dtn.fm/hg8TK), we reported that ‘OvaDx is now undergoing 510K trials.’ It seems we jumped the gun. We reached out to Avant’s CEO, Gregg Linn, to get clarification on our report and he confirmed that the OvaDx approval process hasn’t reached the 510K trial stage yet. 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.

As seen in recent news releases, the OvaDx approval process is alive and well. And Avant is reaching out to the investor community to tell them so. Gregg Linn will be one of the speakers at the Noble Financial Capital Markets’ Twelfth Annual Investor Conference (NobleCon12) in Sandpiper Bay, Florida, on Tuesday, January 19, 2016.

From January 22, 2016, a high-definition video web-cast of Gregg’s presentation and a copy of the presentation materials will be available on the Avant Diagnostics website and as part of a complete catalog of presentations available at Noble Financial websites: www.noblefcm.com, or www.nobleconference.com.

For more information, visit the company website at www.avantdiagnostics.com