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Patent & NIH clinical trials for Arrayit Corp (ARYC) major microarray product line pending FDA approval.


Spiriplex like AllergyPro is one of Arrayit’s marketing partners.


Spiriplex Patent: Method and device for allergy testing and treatment.

https://patents.google.com/patent/WO2016179402A1/en

https://www.freshpatents.com/-dt20161110ptan20160327567.php

Methods of applying proteins to surfaces to form arrays are well known. The immobilization may be covalent or noncovalent, via a linker moiety, or tethering to an immobilized moiety. These methods are well known in the field of solid phase synthesis and micro-arrays, for example as described in Beier et al., Nucleic Acids Res. 27:1970-1-977 (1999), and U.S. Pat. No. 6,101,946 to Martinsky. Examples include binding moieties for attaching proteinaceous molecules to a solid support include streptavidin or avidin/biotin linkages, carbamate linkages, ester linkages, amide, thiolester, (N)-functionalized thiourea, functionalized maleimide, amino, disulfide, amide, hydrazone linkages, and among others. Furthermore, a number of companies offer commercial services for preparing protein arrays, for example Arrayit Corporation (Sunnyvale, Calif.). Preferably, the source of the proteins is an extract of the allergen source, such as those available from GREER® Allergy Immunotherapy (Lenoir, N.C.). Preferably, the extract of the allergen source is standardized.

Aspects of the inventions described herein have been described on the website of ARRAYIT® Corporation (arrayit.com) and links thereon. All such disclosures were made by another who obtained the subject matter disclosed directly or indirectly from the inventor of the present application.




1-2-18: Arrayit completes site visit and laboratory tour with a key business-to-business B2B partner and regulatory consultant regarding submission of a proprietary microarray product line to the United States Food and Drug Administration for FDA clearance https://www.fda.gov


Allergenex/Spiriplex:

http://spiriplex.com/


Spiriplex/AllergyPro

http://allergypro.us/wp-content/uploads/2016/09/ICD-9-to-ICD-10-Codes.pdf




1-3-18 Arrayit advanced microarray technology to be incorporated into a clinical trial by a major pharmaceutical giant in a development that could significantly increase revenues and earnings in 2018 arrayit.com/Products/products.html


United Allergy Services sponsoring Spiriplex.


https://clinicaltrials.gov/ct2/show/NCT03514303




National Institutes of Health: Arrayit submits capabilities statement for major microarray services contract with National Institutes of Health NIH nih.gov

3-21-18: Arrayit sales and marketing team receives $1,050,000 genomics and proteomics pre-solicitation announcement from top government agency National Institutes of Health NIH headquartered in Bethesda Maryland USA and operating with a $31.3 billion annual budget https://www.nih.gov

Arrayit government contracts team reports $440,000 sample testing solicitation from the world leader Department of Health and Human Services National Cancer Institute NCI headquartered in Bethesda Maryland USA and supported by a $5.4 billion annual budget (link: https://www.cancer.gov) cancer.gov



NIH first posted May 2, 2018

* Note: Arrayit Corp (ARYC) began releasing press releases once again in May 2018.

http://arrayit.com/Arrayit_Corporation_ARYC_Corpo/Microarray_Media_-_Press/microarray_media_-_press.html



7-16-2018: Arrayit Corporation Reports Clinical Instrumentation Sale to the United States Food and Drug Administration

http://arrayit.com/Arrayit_Corporation_ARYC_Corpo/Microarray_Media_-_Press/Arrayit_Corporation_Reports_Cl/arrayit_corporation_reports_clinical_instrumentation_sale_to_the.html


9-24-2018: Arrayit Corporation Ships Clinical Instrumentation and Software to the United States Food and Drug Administration

http://arrayit.com/Arrayit_Corporation_ARYC_Corpo/Microarray_Media_-_Press/Arrayit_Corporation_Ships_Clin/arrayit_corporation_ships_clinical_instrumentation_and_software_.html

https://www.fpds.gov/ezsearch/fpdsportal?q=arrayit&s=FPDSNG.COM&templateN=&&templateName=1.5.1&indexName=awardfull


Arrayit Corp (ARYC) Has firmed several immunotherapy partnerships & several clinics have recently enrolled in their Patient Data Solutions allergy testing portal, therefore, one could also easily form the opinion that we are in phase III of the clinical trials & about to enter the final step


A Phase III trial gathers more information about safety and effectiveness, studying different populations and different dosages, using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.
A Phase IV trial for drugs or devices takes place after the FDA approves their use. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies



Further, below are the Medicare Coverage policies along with Arrayit Corp (ARYC) press release a few days before entering the NIH clinical trials.

Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are:

1. Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;

2. Trials supported by centers or cooperative groups that are funded by the NIH,
CDC, AHRQ, CMS, DOD and VA;

3. Trials conducted under an investigational new drug application (IND) reviewed
by the FDA; and

4. Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be
deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain
Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status.

https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/downloads/finalnationalcoverage.pdf




Arrayit Corporation Announces New Clinical Licensure from the Centers for Medicare and Medicaid Services

Sunnyvale, May 09, 2018 (GLOBE NEWSWIRE) -- Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, announces receipt of a new clinical licensure from the Centers for Medicare and Medicaid Services (CMS), which oversees the Clinical Laboratory Improvement Amendments (CLIA) Program. Arrayit’s new CLIA license, issued in conjunction with the Department of Health and Human Services (HHS) and the California Department of Public Health (CDPH), provides certification for its Silicon Valley clinical laboratory.

http://arrayit.com/Arrayit_Corporation_ARYC_Corpo/Microarray_Media_-_Press/Arrayit_Corporation_Announces_/arrayit_corporation_announces_new_clinical_licensure_from_the_ce.html