Vitro Biopharma Obtains CLIA Certification Adding a New Dimension to its Ongoing Stem Cell Clinical Trials

Golden, Colorado—April 2, 2019Vitro Diagnostics, Inc. (OTCPK: VODG), dba Vitro Biopharma announced receipt of a Certificate of Compliance with CLIA (Clinical Laboratory Improvement Amendment) without deficiencies.  This allows Vitro Biopharma to perform clinical laboratory testing, reporting and billing in full compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) according to section 353 of the Public Health Service Act (42 C.F.R. § 263a) and (42 C.F.R § 493).

We will use our CLIA Certification to expand services related to stem cell therapies to include diagnostics as well as therapy including our patent-pending AlloRx Stem Cell™ product.  The testing includes biomarkers to assess stem cell status and the effects of stem cell therapies as well.  Assessment of stem cell status is an emerging aspect of medical diagnostics since stem cell deficiencies may underly diseases, such as MS & Alzheimer’s disease.  Also, efficiency of stem cell therapies is quantified by diagnostic tests such measurement of anti-inflammatory effects, differentiation of stem cells and reduction of autoimmunity in autoimmune diseases.  By using highly sensitive, specific and accurate tests, efficiency of therapies may be determined at higher levels of statistical significance.  The efficiency of stem cell therapies is often measured from patient assessments of joint function and pain that are subject to considerable variation.  Quantitative biomarker testing provides less variability and complements other efficacy tests to enhance measurement of stem cell clinical outcomes.

Keith Burge, Director of Sales and Marketing of Vitro Biopharma said, “Attainment of CLIA certification is continuance of Vitro’s commitment to establishing manufacturing, operating and quality standards as a world class stem cell provider.  ISO 9001 certification and cGMP compliance was instrumental in the company recently gaining approval for our Stem Cell Clinical Trial for Musculoskeletal Conditions by the Bahamas Ministry of Health.  Our ongoing IRB approved trial in the Cayman Islands with our clinical partner, DVCStem, recently provided a treatment to Lou Ferrigno, the “Incredible Hulk”, a testament to the quality to Vitro’s AlloRx product”.

Tiana Tonrey, MS and COO of Vitro Biopharma said,  “ {I would suggest our regulatory status summary, ISO, FDA reg …& expansion of operations based on CLIA certification, plans for regulatory approvals, etc}

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Dr. James Musick

Chief Executive Officer

Vitro Biopharma

(303) 999-2130 Ext. 3


Source: Vitro Diagnostics, Inc.