Replies to post #80389 on Arrayit Corporation (ARYC)

[Alyssa]

It could very well be OvaDX. It's time. And it's MAJOR.

"Arrayit Corporation Taps DOCRO, Inc. to Facilitate FDA Approval of OvaDx - Top Contract Research Organization Is Retained to Expedite Submission and Approval of the Company's Pre-Symptomatic Ovarian Cancer Screening Test

Press Release Source: Arrayit Corporation On Monday March 22, 2010, 7:00 am EDT

SUNNYVALE, CA--(Marketwire - 03/22/10) - Arrayit Corporation (OTC.BB:ARYC - News), a leader in life sciences, healthcare and molecular diagnostics, announced today that the company has appointed DOCRO, Inc. of Seymour, Connecticut, to assist in obtaining FDA approval for OvaDx. DOCRO has steered nearly 100 In Vitro Diagnostic (IVD) clinical trials through the Food and Drug Administration in the past 12 years, along with 39 pre-market approval (PMA) and 46 510(k) applications. DOCRO has an unparalleled 99% success rate with the FDA.

Arrayit's OvaDx Pre-Symptomatic Ovarian Cancer Test will be the market's first comprehensive diagnostic screen for ovarian cancer, and will be recommended for all women over the age of 35. OvaDx uses approximately 100 proteomic biomarkers in a microarray format to identify molecular beacons of ovarian cancer that accumulate in the bloodstream as a result of the body's natural immune response to developing ovarian tumors. Arrayit's microarray test, which detects both early and late stage ovarian cancer, leverages the company's patented microarray platform and distinguished 13-year track record as a microarray technology leader. OvaDx will be marketed and sold by the company's subsidiary Arrayit Diagnostics, Inc., in Houston, Texas.

"We are pleased to retain DOCRO for FDA approval of OvaDx," stated Arrayit CEO Rene Schena. "DOCRO brings a breadth and depth of experience that matches the importance of bringing the first early stage pre-symptomatic ovarian cancer screening test to market."

[MikeCr]

rh, I have no idea.

One thing, now that Arrayit has CLIA certification, their lab can process human blood samples. Up to now they could not run samples for clinical trials of any diagnostics tests or process samples for diagnostic tests.

The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.

[WebSlinger]

Similar verbiage was used in other tweets:

26 Feb 2018:

"Arrayit clinical team assembles technical documents for a major microarray technology product line in preparation for 510(k) clearance submission with the United States Food and Drug Administration FDA"

Arrayit clinical team assembles technical documents for a major microarray technology product line in preparation for 510(k) clearance submission with the United States Food and Drug Administration FDA https://t.co/mXK470GbIR pic.twitter.com/vdzMI64iNX

— Arrayit Corporation (@arrayit) February 26, 2018

26 Jan 2018:

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

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://t.co/mXK470GbIR pic.twitter.com/cvQrTiDbV0

— Arrayit Corporation (@arrayit) January 26, 2018