GOLDEN, CO / ACCESSWIRE / April 2, 2019 / Vitro Diagnostics, Inc. (OTC PINK: 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 as measurement of anti-inflammatory effects, differentiation of stem cells and reduction of autoimmunity. 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 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. Also, recent research has shown that measurement of specific biomarkers improves diagnosis and identification of poor outcomes in TBI.
Keith Burge, Director of Sales and Marketing of Vitro Biopharma said, ”Attainment of CLIA certification is continuance of Vitro Biopharma’s commitment to establishing manufacturing, operating and quality standards as a world class provider of stem cell therapies and related services. ISO 9001 certification and cGMP compliance were instrumental in the Company gaining approval for our Stem Cell Clinical Trial for Musculoskeletal conditions by the Bahamas Ministry of Health. Our ongoing IRB approved clinical trial in the Cayman Islands with our clinical partner, DVCStem recently provided treatment to Lou Ferrigno, the ”Incredible Hulk”, a testament to the quality and effectiveness of Vitro Biopharma’s AlloRx Stem Cell™ product.
Tiana States, MS and COO of Vitro Biopharma said, ”Our CLIA Certification is an important milestone as we build our regulatory accreditation as a commercial biologics manufacturing operation. This complements our cGMP compliant and ISO 9001 Certification by providing certification to our clinical laboratory testing services as well.”
Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company’s auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain ”forward-looking statements”. Such forward looking statements are identified by words such as ”intends,” ”anticipates,” ”believes,” ”expects” and ”hopes” and include, without limitation, statements regarding the Company’s plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company’s products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company’s filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.
Dr. James Musick
Chief Executive Officer
(303) 999-2130 Ext. 3
E-mail: [email protected]
SOURCE: Vitro Diagnostics, Inc.
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