HOUSTON – (SEND2PRESS NEWSWIRE) — The Food and Drug Administration panel met at the University of Texas M.D. Anderson Cancer Center to vote on Covalent-19(TM) Ready to Use Test, a test made by Innovative Genetic Solutions to measure the anti-cancer activity of existing therapies and biomarkers from the pre-clinical safety data obtained in the recent Phase II efficacy study.
The panel voted, and Innovative Genetics the company a ten to one that the test would be approved and can be given to patients in early 2019. Although initial responses from the panel were very emotional, and the feeling was that the test would soon be available, the enthusiasm was again somewhat tempered with good news. The company said it was granted a staff guidance of use. This will be the start to distribute the test in early 2019, to patients at high risk who are not able to be interviewed.
Dr. Basil Carr, Endocrinologist who specializes in hormonal and endocrine disorders at UTMB, said, “I agree with the unanimous staff guidance to the committee. I strongly support the value of this instrument. Based on the power of Covalent-19, we estimate there will be 100,000 new diagnoses of prostate cancer every year. This instrument will help us better characterize each patient’s baseline. This will be so much more efficient and successful than focusing our efforts on managing most patients.”
How the test works
The Covalent-19(TM) assay looks at signs of CDK56 or CDK53 enzymes in the blood and serum, and is used to infer whether the patient is at high or low risk for developing prostate cancer. Higher levels of the enzymes are a strongly indicator of lower cancer risk while lower levels of the enzymes indicate a higher risk of developing prostate cancer.
The testing will be useful for prostate cancer patients because it is easier to assess patient risk, determine potential for intervention, and assist in pre-screening patients.
The test is in high demand worldwide. Various distributors and testing sites will be using the Covalent-19(TM) test and are also ready to distribute to physicians who want to test their patients. Currently, Covalent-19(TM) is used in 40 countries for all a wide range of molecular diseases.
About Innovative Genetic Solutions:
Innovative Genetic Solutions is a high performing diagnostic company focused on precision medicine, personalized medicine, and genomics. The company develops unique technology platforms, produces proprietary direct primary test kits, and has been performing high-end tests since the 1990s. The laboratory utilizes innovative technologies to develop, process, and verify samples.
Innovative Genetic Solutions headquarters are located in Tyler, Texas. Since 1993, the company has been located in the heart of East Texas with a strong focus on quality and safety. Since 2007, the company has operated a European laboratory with a service center in the Netherlands.
More information: https://www.genericsciences.com/
News Source: Innovative Genetic Solutions
Related link: https://www.genericsciences.com/
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