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This is still a swab test. Very unpleasant where they put a swab deep into your nostrils and back of the throat.
A finger stick test requiring 4 drops of blood is less invasive.
The United States, which has the most known coronavirus cases in the world, continues to lag in tests per capita,
IMO Not over yet. ARYC will most likely appeal
.
I thought you talked to Arrayit and got an answer. Why start the lawsuit?
They meant to say sensitivity, not selectively, but the 95% sounds good.
A ‘negative’ coronavirus test result doesn’t always mean you aren’t infected
https://www.washingtonpost.com/science/2020/03/26/negative-coronavirus-test-result-doesnt-always-mean-you-arent-infected/
The FDA has received many application for emergency approval of tests, It's taking time to review/approve or deny them all.
The CLIA labs that have applied can sell the tests pending approval
Because The FDA approval is for AYTU to distribute the test in the U.S.
Aytu BioScience (NASDAQ:AYTU) has extended its distribution right to commercialize the clinically validated COVID-19 IgG/IgM Rapid Test.
The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation). The COVID-19 IgG/IgM Rapid Test delivers clinical results between 2 and 10 minutes at the point-of-care.
This amendment expands Aytu's commercial rights to distribute and commercialize the COVID-19 test in North America, including U.S., Canada and Mexico.
This point-of-care test has been validated in a 113 patient clinical trial and is CE marked.
https://seekingalpha.com/news/3553306-aytu-bio-expands-distribution-rights-for-covidminus-19-test-shares-up-21-premarket
Hey Erik , but they were speedy 80% wrong test results LOL.
To some people (not me) speed trumps accuracy.
Marh 23, 2020 ENGLEWOOD, Colo. (KDVR) — Aytu BioScience, Inc. announced Monday that the company may begin the distribution of the first 100,000 COVID-19 IgG/IgM Rapid Tests throughout the country this week. The test delivers results between 2 and 10 minutes at the point of care and are for professional use only.
Josh Disbrow Aytu BioScience’s Chief Executive Officer, said , “We are moving as quickly as we can to bring the COVID-19 IgG/IgM Rapid Test to the U.S. professional medical community. With product now in transit to our warehouse in Colorado we’re optimistic that we can have test kits ready for sale in the very near term. In the two short weeks since signing our distribution agreement, we have ordered our first 100,000 tests and have received confirmation from FDA that we may begin distribution. We are optimistic that we’re now just days away from placing these COVID-19 test kits into the hands of healthcare professionals.”
The COVID-19 IgG/IgM Rapid Test is used in detection of the 2019 Novel Coronavirus antibodies in human whole blood, serum or plasma. This point-of-care test has been validated in a patient clinical trial.
Aytu BioScience is a commercial-stage specialty pharmaceutical company. Aytu recently acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM Rapid Test.
https://kdvr.com/news/coronavirus/fda-approves-rapid-coronavirus-test-created-in-colorado/
You say
I prefer accuracy over speed.
The rapid tests are useful in a hospital setting when dealing with very sick people, but for the population at large, an accurate test is better.
The rapid tests have around 10% false negatives. One out of 10. You do the math.
No public announcements from ARYC because of the form 15 they filed with the SEC back in August. IMO
ihubers only know about it from emails sent from Mark ARYC president to people who asked him if arrayit had a covid-19test.
He answered yes and that it had been submitted to FDA for emergecy approval.
Then the website was updated, but it's hard to find the pdf file where they describe the test.
Then some people got another email from Mark saying that they had many inquiries for the test blah, bla, blah.
To get a big bump in the pps they need a PR not info on ihub
But the rapid tests could have a high number of false negatives, that's why the lab tests are better.
IMO-Arrayit test is not a rapid test. But the result would be more definitive.
Delsurfer, If you want to read the full transcript of the 3/23 briefing is at the White House website:
https://www.whitehouse.gov/briefings-statements/remarks-president-trump-vice-president-pence-members-coronavirus-task-force-press-briefing-9/
This is the part about the finger prick test. She also mentions "point of care" blood tests which are done close to the patients, and the result is known in a short time. Some companies are claiming in 10 to 15 min. There are a lot of companies developing tests, so Dr Birx has to sort out which ones are accurate and reliable.
False positives an negatives are a concern. Other Arrayit tests have high sensitivity and specificity, if the covid-19 one has high ones, that an advantage.
Trump answered the question about test accuracy in his typical fashion.
The allergy test does not need FDA approval because it's a LDT test.
Medicare and Medicaid approved the test for payment,
I remember reading a post saying that around 50% of allergy test billing by Arrayit is from these entities.
She said we are looking a other tests in development
DR. BIRX: I can’t answer because I have to look at where each of the companies are that are in their development processes.
Q So, realistically, how long until that’s (=finger prick blood test) approved and available? What do you —
DR. BIRX: I can’t answer because I have to look at where each of the companies are that are in their development processes.
Q. Dr. Birx, a question about the serology blood tests, which some people said hold some real promise here. When will those be FDA approved and when would they be widely available?
DR. BIRX: So that’s what she was just asking about. So these IgG and IgM — both point of care — I can tell you it would be no problem making ELISA today. But then you’re drawing blood, you’re processing blood, you’re running plates; that’s what we did in the past. We really want a finger-prick-type assay where you can just put a fingerprint on and get your IgG and IgM. So that’s what we’re working on right now.
Q So, realistically, how long until that’s approved and available? What do you —
DR. BIRX: I can’t answer because I have to look at where each of the companies are that are in their development processes.
Q Sounds like a while then.
DR. BIRX: Well, there’s some that are developed now that they were using in Singapore. So we’re looking at those to see how those work.
THE PRESIDENT: We have — we have some. Should be fairly quickly.
Q So we’re looking at those but, you know, we’re very quality-oriented because we want to make sure we don’t give people false negatives or false positives.
The president: goes on a tirade about the media....WOW!
https://www.whitehouse.gov/briefings-statements/remarks-president-trump-vice-president-pence-members-coronavirus-task-force-press-briefing-9/
watch the video on youtube
covid coordinator-We really need a finger prick type assay -
White House Coronavirus Coordinator Dr. Deborah Birx
Emphasizes Importance Of A Finger Stick Blood Test For
SARS-Cov-2 (COVID-19)
She says "we really want a finger prick type assay where you just put a finger print to log your IgG and IgM so that's what we are working on right now"
This sound like a cut and paste from another post from at least 4 years ago.
The FDA is allowing labs to sell their covid-19 tests while their EUA emergency application is being reviewed, before FDA approval.
Arrayit submitted their application las week, so they can legally sell the test.
I sent Email to that covid-19@arrayit.com address 2 days ago. No response.
Has anyone gotten an answer?
1. IMO. Because there has been no announcement from the company.
2. https://www.google.com/amp/s/www.wsj.com/amp/articles/fda-to-allow-private-companies-to-market-coronavirus-test-kits-without-prior-approval-11584407046
1. Arrayit has not said it's a test at home kit. They have over 1700 distributors of the allergy test that have relationships with doctors offices. That's probably how they are offering the test.
2. The FDA is allowing CLIA certified labs like Arrayit to sell their tests pending FDA approval of their applications. They will approve retroactively.
3. Arrayit has a blood test which offers more diagnostic information than the swab tests.
Agreed. It was most likelly not pure coincidence that ARYC stopped filing in April 2016 just as Iconic loan could be converted. Not being current would not permit Iconic to sell shares in the open market. After that Iconic sued. One of the claims in the first lawsuit was that Arrayit was notcurrent in its filings.
IMO because the form 15 they filed to suspend fins filings, they have to stay silent until they file the fins.
This test should be a catalyst for them to file soon so they can do PRs
The FDA is allowing labs to sell the test before approval, then the FDA will verify the accuracy of the test and approve it retroactively
The way I read the article, the swab test is more limited and a blood test does what the swab test foes plus more
The FDA is not doing tests or storing samples from people to compare the results of the many companies that are applying for emergency tests.
The FDA relies on validation data submitted by the applicant
Finger stick blood test.
http://www.arrayit.com/SARS-CoV-2COVID-19TestInstructions.pdf
My guess. IMO.
Other emails from Mark said Arrayit has a test.
On Friday the 13th the email to Sloan said it had been submitted
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=154332071
Can't just compare one patient.
It could match the result by chance. Have to have statistics showing percentage of true positives and negatives
I believe that the FDA is letting CLIA labs to sell validated tests while their EUA emergency applications are being processed.
Arrayit submitted its application last Friday
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics
No thanks, time for Arrayit to have a professional website. I can navigate every other company website just fine on my phone.
How is the public supposed to find out about the test by reading about it on ihub?
The test is real, the rollout is typical Arrayit. Word of mouth pointing to a crappy website to learn how to order it.