Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Reminds me of the use of "Individual 1" in the Michael Cohen/Trump case regarding the hush payments to Stormy Daniels. Since they did not charge the president, although he had directed Cohen to make the payments, they called him Individual 1.
Wow. We wuz scammed by a con artist and company .
What document are you quoting from?
Page last reviewed: February 24, 2020
OvaDx was the main reason I too bought shares in 2010. It's been a nightmare of a ride for such promising and needed test. Better,competent management would have got this test FDA approved and in the market 10 years ago.
AVDX, Mark and Rene's brain child, is kaput. All its assets excluding OvaDx were sold to OBMP. M & R created the subsidiary Arrayit Diagnostics in 2009 to get OvaDx FDA approved and to market OvaDx, and it was managed by the Texas crooks. AD changed its name to AVDX and went public and never accomplished anything with OvaDx but still held OvaDx hostage. Then they merged with Theralink. Now the Theralink assets were sold. OvaDx is back to square one, hopefully in Arrayit's hands. We have to wait (forevermore?) for the PR about it that Mark promised many moons ago.
OncBioMune Announces Closing of Asset Purchase Agreement with Avant Diagnostics
https://www.accesswire.com/593012/OncBioMune-Announces-Closing-of-Asset-Purchase-Agreement-with-Avant-Diagnostics
OncBioMune Announces Closing of Asset Purchase Agreement with Avant Diagnostics
https://www.accesswire.com/593012/OncBioMune-Announces-Closing-of-Asset-Purchase-Agreement-with-Avant-Diagnostics
Eian OvaDx was excluded from the sale of AVDX assets to OBMP, so AVDX had to dispose of it somehow...IMO probably was tranferred back ARYC in some kind of deal. The https://antibodycovidtest.com/ site says "We also provide Pre-symptomatic Ovarian Cancer screening services." from Arrayit lab, so that's an indication it is back at Arrayit
See BeckElliot's post: Arrayit has an active CLIA certificate
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=155440422
The FDA does not regulate LDTs but it can issue powerful advisories and warnings...Here is an example
Ha, ha. So AVDX just threw Ovadx in the garbage when they turned the lights off.
Educated guess. OvaDx was not part of the deal to sell AVDX assets to OBMP.
AVDX will cease to exist after the sale. OBPM will be renamed Theralink. So what else could have happened to Ovadx.
And ARYC is providing ovarian cancer testing services now.
Eian, AVDX's assets sale to OBMP excluded OvaDx.
And ARYC is providing ovarian cancer testing services now. So it could be that the OvaDx asset is being or has been sold to ARYC. We don't know what kind of deal they could have made because Arrayit doesn't file reports to tell us what's going on.
Thanks. Let's see if the FDA lets them do it. I suppose that ARYC has the test back from AVDX
I wouldn't say that ARYC has the FDA "blessings" to sell the ovarian cancer screening test as an LDT test.
For years they were pursuing PMA FDA APPROVAL for screening then they changed the strategy to pursue 510k FDA approval for monitoring.
Can they get away with offering the test now as LDT?
The FDA is concerned about tests that could cause harm, like telling someone incorrectly that they have cancer and go through unnecessary dangerous procedures
You mean depending on how long after the infection the test is taken?
I believe that the LA people are providing the ovarian cancer test to patients through their the patient's health care providers as an "LDT CLIA certified Test"
LDT tests don't require FDA approval. We'll see if that flies.
Obviously the people in Louisiana behind https://antibodycovidtest.com/
are offering the test to regular women ordered by their doctor, not in a research capacity.
"We also provide Pre-symptomatic Ovarian Cancer screening services."
The IRB approval was just to allow them to use the blood samples in clinical trials before they submit a 510(k) application.
The test is not FDA approved. I don't see how the LA people could offer it to patients.
By the way, a previous version of the Arrayit webpage for the covid test had the same wording of providing the ova screening. Now it's gone.
The new page got rid of that sentence http://www.arrayit.com/EReply.html?#reply
Dont they need FDA approval to do that
Jeffpacman, you say
From stockman 08/05/18 11:36:08 PM
Here is how ARYC describes the accuracy of their covid-19 test. :)
Was that before or after the SEC suspension? I don't think they would be too chatty and upbeat after ARYC got suspended and under investigation.
A. the deletion list applies to commercial manufacturers.
B. ARYC is a laboratory, NOT a commercial manufacturer.
C. Per FDA guidance, laboratories are not required to submit an EUA request, but they may do so if they want.
What Tests Should No Longer Be Distributed for COVID-19?
Q: What commercial manufacturers of serological tests had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have now been removed from that notification list? (Updated 5/22)
The commercial manufacturers in the list below provided notification to FDA
that they validated and intended to distribute a serology test as set forth in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. FDA had previously included them on the website notification list of commercial manufacturers distributing serology test kits under that policy, but they have now been removed from that notification list and placed on the list below. As noted in the guidance, if an EUA request is not submitted by a commercial manufacturer of a serology test within a reasonable period of time, or if significant problems are identified with such a test that cannot be or have not been addressed in a timely manner, FDA intends to remove the manufacturer and test from the notification list. Commercial manufacturers may also voluntarily withdraw their test notification, and such tests are noted with an asterisk.
(list of 29 commercial manufacturers)
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-testing-sars-cov-2
But the FDA does not object to ARYC selling their test.
I think you need to re-read again. The PR clearly talks about commercial manufacturers.
Arrayit is in a different category, the CLIA labs category.
It went to 0.20 because of the expectation of the fins being filed in 1Q-2019. It went down to .04 on April 1, 2019 when they didn’t file
you say: "Rene and Todd destroyed/dismantled the company around him"
Actually, Rene and Todd started the company, then known as Telechem, as a private business, then Mark joined in after.
The 10 day period applies to commercial manufacturers not to CLIA labs like Arrayit. The FDA does not object to CLIA labs selling their test if they notify the FDA that they have a validated test.
The FDA does encourage CLIA labs to apply for EUA, but i't not required.
Sorry, but hydroxychloroquine IS NOT being recognized as a cure to covid-19.
The FDA recommends that it only be used in clinical trials under strict medical supervision.
"after the 10 day stress test by weeks end""
where did that dealine come from?
The company never formally announced the test. They stealthily rolled it out. We only became aware of it from Mark answering a few emails from people who asked him directly. Then a few people discovered it being mentioned by distributors in videos and their websites.
Then the whole world became aware of the test from the SEC suspension order and the negative press that followed.
No wonder the pps went down instead of up.
Supreme leadership at its best.
Are you serious that they would tell the FDA that they have a test, that it's been validated and that they are selling it and it's all a lie. C'mon
They were suspended by the SEC because the info in the market place said the test was "approved".
You know what they would do to them if there was no test and they lied to the FDA about its existence?
You may have a point on the rest of your post but you're dead wrong about this sentence:
ARYC is also marketing the covid test on its website and through distributors and 1500 clinics that have signed on to the portal
1) PSA was not mentioned in the Jacksonville story.
2) everybody knows that an antibody test is not used to diagnose covid-19 but to determine if you were infected in the past.
3) it was the doctor's decision to wait untl the test is reviewed by the FDA, but he can legally offer it because under the FDA guidelines Arrayit can legally sell it without an FDA review.
https://www.actionnewsjax.com/news/local/duval-county/action-news-jax-investigates-jacksonville-chiropractors-claims-surrounding-allergy-testing-that-also-detects-covid-19/BBXPEAWWQVEXVBMZ6M7IWBDHLA/
I read the Jacksonville story, what's so alarming about it?