Life Science Engineering Consultant
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All good questions! It would be more efficient to go back and read the many postings of SD who has addressed most of these past issues at one time in or another. Hopefully you can formulate your own understanding of why we are where we are today. Rest assured Arrayit will succeed in the end because it has the fortitude and the knowledge that it holds the key to a leading edge technology that will be in high demand in the very near future. Sorry,this is my understanding.
That is a good question for TDBOW. I am only here to help the misinformed.
TDBOW's issue he was saying Arrayit was no longer CLIA approved since 4/18/20. They would not have been on that list unless they were CLIA compliant.
Note: Throughout this page and the Policy for Coronavirus Disease-2019 Tests, references to laboratories that are "certified to perform high complexity testing under CLIA" or to "high-complexity CLIA-certified laboratories" are referring to CLIA-certified laboratories that meet the regulatory requirements to perform high-complexity testing.You
TDBOW I am trying to help you here.
This Statement is made above the page that lists Arrayit and others as a Laboratory now providing a Serology Test.
Note: Throughout this page and the Policy for Coronavirus Disease-2019 Tests, references to laboratories that are "certified to perform high complexity testing under CLIA" or to "high-complexity CLIA-certified laboratories" are referring to CLIA-certified laboratories that meet the regulatory requirements to perform high-complexity testing.
Vetting is for the Covid test itself. Arrayit notified them and the they were put on the list because they qualified under CLIA.
Sorry TDBOW. Arrayit would not be listed on the SEC Laboratories list for Serology testing without CLIA compliance. Your CLIA approval list for ARYC has not been updated yet. Simple as that.
I searched your website and could not find a list.
I searched all the possibilities and could not find a list. Sorry..
What list are you looking for?
ARYC is listed under serology tests.
Q: What laboratories are offering serology tests under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? (Updated 6/2)
Doo...You are simply misinterpreting what you have posted. ARYC is a CA State & Federal registered CLIA approved lab and can continue supplying their serology blood test without EUA approval.
As of 5/21 Arrayit is a Laboratory NOT a Commercial Manufacture
Laboratory Authorization Status Settings for Use1
Arrayit Corporation Not FDA Authorized H
BioDiagnostic Inc. Not FDA Authorized H
Center for Cellular Therapy Medical University of South Carolina Not FDA Authorized H
DLS Research & Ventures Not FDA Authorized H
EDP Biotech Corporation Not FDA Authorized H
Emory Medical Laboratories Not FDA Authorized H
Enzo Clinical Labs Not FDA Authorized H
Genalyte, Inc Not FDA Authorized H
IGeneX Inc. Not FDA Authorized H
IMMYLabs Not FDA Authorized H
KSL Diagnostics Not FDA Authorized H
LabCorp Center for Esoteric Testing Not FDA Authorized H
OneBlood, Inc. Not FDA Authorized H
University of Arizona Genetics Core for Clinical Services Not FDA Authorized H
University of Minnesota Advanced Research and Diagnostic Laboratory Not FDA Authorized H
Vibrant America Clinical Labs Not FDA Authorized H
White Coat Sciences Not FDA Authorized H
To back Dr. Fauci's statement(from the website) Arrayit further says:
Proprietary Technology
accurate results
Knowing your quantitative levels of immunoglobulin E (IgE) against 12 SARS-Cov-2 biomarkers, we ensure a high degree of accuracy and is forward looking for any possible mutations. Knowing the total IgE value allows the doctor to determine how well your body is responding to the virus in antibody production.
This statement by Fauci from the Arrayit website may help explain how IGe can be used for both.
.."We must not confuse Allergy symptoms with COVID-19 flu symptoms. We’re in high pollen season trigering Allergies - causing congestion, Rhinitis (runny nose) and Aerophagia (mouth breathing) leading to bacterial sore throat and fever. These symptoms together present as flu and may symptomatically be confused with COVID-19. It’s important we eliminate Allergy as a cause of these symptoms when diagnosing for COVID-19... (paraphrased)"
- Dr. Anthony S. Fauci, Director of Allergy and Infectious Disease (NIAID)
Libra click on the virus and click again on
Sars-Cov-2. It's not readily obvious to click twice...just being honest.
This key quote from the new website is from:
Colonel Brian Robertson, MD Assistant to the Surgeon General for Asthma and Allergy
From the Arrayit website Read Carefully:
Speaking to the current COVID-19 Neophangia P Swab test using RTPCR: “The RTPCR test is only 70% sensitive. For screening tests in a pandemic, you want the sensitivity as high as possible to avoid false negative tests. The IGG (Antibody test) has sensitivity in the 90-100% range, so it is a much better test. Clinically, it doesn't matter if IgM and/or IgG is detected. Since no one has existing IgG to this viral protein, during the pandemic, We can assume that the presence of either type of antibody is proof of infection.”
That is what I understood under the rules of form 15. The risk remaining for Arrayit is revocation if financial delinquency continues...they certainly are aware of this. I believe they are getting reliable advice by their Lawyer who was formerly employed by the SEC.
I am not focusing or implying the form expiration date May 31, 2021 is a deadline date. Has anyone come forth and demonstrated a date when Arrayit has to produce financials while under this form?
This is what keeps me convinced they are planning a comeback.
15-12B for Arrayit Corp
OMB APPROVAL OMB Number: 3235-0167 UNITED STATES Expires: May 31, 2021 SECURITIES AND EXCHANGE COMMISSION Estimated average burden Washington, D.C. 20549 hours per response 1.50 FORM 15 CERTIFICATION AND NOTICE OF TERMINATION OF REGISTRATION UNDER SECTION
Arrayit Corp [SIC: 3826]
Sec has no litigation action on Arrayit yet.
https://www.sec.gov/litigation/litreleases.shtml
Thank You Mike for compiling this info in the right order.
I researched the missing 4 Labs and could not find their status.
I wonder if they withdrew themselves before the 10 day deadline or FDA removed them due to invalid test results. Arrayit remains on the list for now.
Pennsy please read: Repost
I believe Arrayit did bill 2 million/wk but collecting the actual revenue is another story altogether.
My wife has been in medical billing for 20 years and she agrees that billing would not have kicked in till the fall of 2019....too late for profits to exceed 10 million for the year because of the following rules:
1)Credentials verification process is typically completed in 60 – 90 days and the contracting phase complete in another 30 days for a total of 90 – 120 days from the time an insurance company receives the providers credentialing application. This timeline should be considered a general guideline for a standard credentialing process.
2)Medicare registration could take up to 150 days.
Therefore Reimbursements from Private Insurance and Medicare for lab testing service may not have begun until the fall of 2019.
Collecting only an average partial payment(?) for an Allergy Tests from Sept-Dec may have significantly reduce Arrayit's revenue for 2019.
Total Short Term + Long Term Liabilities + Expenses may have reduced their Revenue resulting in Total Assets well below $10 million for 2019.
Thank You Beckelliot. Here is more confirmation.to
Sunnyvale, June 17, 2019 (GLOBE NEWSWIRE) -- Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, in accordance with the provisions of the Business and Professions Code has received licensure extension from the California Department of Public Health (CDPH) to operate a clinical laboratory in the State of California into 2020. This valuable commercial entitlement requires compliance with all state and federal clinical laboratory regulatory requirements including high level performance on proficiency testing and outstanding resulting of the company’s allergy and dietary wellness testing services. CDPH ensures public health for individuals, families and communities by confirming proper clinical laboratory operation from its healthcare providers in the nation’s most populous state, comprising 39 million residents and an annual healthcare expenditure topping 294,000,000,000 ($294 billion).
More Proof: No Sec litigation against Arrayit.
https://www.sec.gov/litigation/litreleases.shtml
More Proof: No action against Delinquent Filer Arrayit
https://www.sec.gov/divisions/enforce/delinquent/delinqindex.htm
Still no litigation activity for Arrayit.
https://www.sec.gov/litigation/litreleases.shtml
All of you deserve the credit. Feeding off Scorpgirl's post and maximizing the information within is what we longs look for. Keep it coming!
Nice work Libra & Mike!!
I'm sorry for your loses in this investment but you are not alone. This is a risky market and I for one know the pitfalls of investing in OTC stocks but Arrayit is much different. You have the right to vent like every other investor here but trashing every positive post serves no purpose than feeding your anger. Believe me, I feel your pain.
All these PR's and tweets can be used against them in court. Make no sense they would purposely incriminate themselves by lying to shareholders and the public in order to gain what? Do you think we longs would have continued to invest and support a futile cause.
(Update 4-30) Arrayit Still distributing - Awaiting Authorization with other notable Labs
Laboratories that have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D:
Where the Authorization Status is "FDA Authorized," the FDA reviewed and issued an EUA for the test after notification was given. Where the Authorization Status is shown as "Not FDA Authorized," the FDA has not yet reviewed the laboratory's validation and issued an EUA for the laboratory's test, and the test is included in this list to provide transparency regarding the notifications submitted to FDA. The "Setting for Use" designation of "H" refers to a laboratory certified under CLIA to perform high-complexity testing.
Search:
Laboratory Authorization Status Settings for Use1
Access Medical Laboratories Not FDA Authorized H
Arrayit Corporation Not FDA Authorized H
Beaumont Health Not FDA Authorized H
BioDiagnostic Inc. Not FDA Authorized H
Bioreference Laboratories Inc. Not FDA Authorized H
Boston Heart Diagnostics Not FDA Authorized H
Dept of Pathology & Laboratory Medicine @ The Medical Center, Navicent Health Not FDA Authorized H
DLS Research & Ventures Not FDA Authorized H
EDP Biotech Corporation Not FDA Authorized H
Emory Medical Laboratories Not FDA Authorized H
HealthQuest Esoterics Not FDA Authorized H
IMMYLabs Not FDA Authorized H
Lenco Diagnostic Laboratory Not FDA Authorized H
Mayo Clinic Not FDA Authorized H
Michigan Health Clinics Not FDA Authorized H
National Jewish Health Not FDA Authorized H
Otogenetics Not FDA Authorized H
Progenesis, Inc. Not FDA Authorized H
Rady Children's Hospital - San Diego Not FDA Authorized H
Roseland Community Hospital/American Medical Lab Not FDA Authorized H
Universal Meditech Inc. DiagnosUS® SARS-CoV-2 Antibody (IgG/IgM) Test Not FDA Authorized H
University of Minnesota Advanced Research and Diagnostic Laboratory Not FDA Authorized H
Vibrant America Clinical Labs Not FDA Authorized H
VRL Eurofins Not FDA Authorized H
Look at it this way. No News is good news. No Litigations yet.
https://www.sec.gov/litigation/litreleases.shtml
I've been invested in this stock for four years and followed it closely. Why would Arrayit jeapordize the investment of all the insiders and their own....to what end?
I believe Arrayit did bill 2 million/wk but collecting the actual revenue is another story altogether.
My wife has been in medical billing for 20 years and she agrees that billing would not have kicked in till the fall of 2019....too late for profits to exceed 10 million for the year because of the following rules:
1)Credentials verification process is typically completed in 60 – 90 days and the contracting phase complete in another 30 days for a total of 90 – 120 days from the time an insurance company receives the providers credentialing application. This timeline should be considered a general guideline for a standard credentialing process.
2)Medicare registration could take up to 150 days.
Therefore Reimbursements from Private Insurance and Medicare for lab testing service may not have begun until the fall of 2019.
Collecting only an average partial payment(?) for an Allergy Tests from Sept-Dec may have significantly reduce Arrayit's revenue for 2019.
Total Short Term + Long Term Liabilities + Expenses may have reduced their Earnings resulting in Total Assets well below $10 million for 2019.
I believe Arrayit did bill 2 million/wk but collecting the actual revenue is another story altogether.
My wife has been in medical billing for 20 years and she agrees that billing would not have kicked in till the fall of 2019....too late for profits to exceed 10 million for the year because of the following rules:
1)Credentials verification process is typically completed in 60 – 90 days and the contracting phase complete in another 30 days for a total of 90 – 120 days from the time an insurance company receives the providers credentialing application. This timeline should be considered a general guideline for a standard credentialing process.
2)Medicare registration could take up to 150 days.
Therefore Reimbursements from Private Insurance and Medicare for lab testing service may not have begun until the fall of 2019.
Collecting only an average partial payment(?) for an Allergy Tests from Sept-Dec may have significantly reduce Arrayit's revenue for 2019.
Total Short Term + Long Term Liabilities + Expenses may have reduced their Revenue resulting in Total Assets well below $10 million for 2019.
No News is good news. No Litigations yet.
https://www.sec.gov/litigation/litreleases.shtml
Your analogy is good and agrees with mine
By the formula:
Total assets is the sum of non-current and current assets and this total should equal the sum of stockholders’ equity and total liabilities combined. The formula for Total Asset is: Total Assets = Non Current Assets + Current Assets
What inventory you have not sold by the end of the year is valued at your cost.
We don't know how much inventory was sold of the $240 million dollar run during 2019.
Here are my thoughts that may explain why Arrayit did not need to publish their financials by 4/30/2020.
How long is the insurance credentialing process?
Credentials verification process is typically completed in 60 – 90 days and the contracting phase complete in another 30 days for a total of 90 – 120 days from the time an insurance company receives the providers credentialing application. This timeline should be considered a general guideline for a standard credentialing process.
Medicare registration could take up to 150 days.
Reimbursements from Private Insurance and Medicare for lab testing service may not have begun until the fall of 2019.
Collecting only an average partial payment(?) for an Allergy Tests from Sept-Dec may have significantly reduce Arrayit's income for 2019.
Total Short Term + Long Term Liabilities + Expenses may have reduced their Revenue resulting in Total Assets well below $10 million for 2019.
Form 15 expiration date is May 2021 so what happens from here to there?