Recently, in Avant Diagnostics set
to exploit new opportunities in the laboratory testing market
(http://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
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