“The [FDA] has become increasingly concerned that some tests made by laboratories and not authorized by the FDA may not provide accurate and reliable test results or perform as well as FDA authorized tests. This may negatively impact treatment decisions.” – June 20th,...
The FDA has become “Increasingly Concerned” of LDTs
“The [FDA] has become increasingly concerned that some tests made by laboratories and not authorized by the FDA may not provide accurate and reliable test results or perform as well as FDA authorized tests. This may negatively impact treatment decisions.” – June 20th,...
National Institue of Health Statment Confirms Lack of Regulation of Genetic Tests
“Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.” – The National Institutes of Health https://lnkd.in/gcRf3Hg6. Most Precision Medicine is guided by genetic or genomic...
National Institue of Health Statment Confirms Lack of Regulation of Genetic Tests
“Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.” – The National Institutes of Health https://lnkd.in/gcRf3Hg6. Most Precision Medicine is guided by genetic or genomic...
National Institue of Health Statment Confirms Lack of Regulation of Genetic Tests
“Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.” – The National Institutes of Health https://lnkd.in/gcRf3Hg6. Most Precision Medicine is guided by genetic or genomic...
Test Wisely Transparency Survey Sent to 11 Hereditary Cancer Testing Laboratories
Surveys sent to 11 major labs to facilitate comparison of similarities and differences between test options SANDY, UT, USA, June 15, 2023/EINPresswire.com/ — At the end of May, a transparency survey was sent to the CEOs of eleven major clinical laboratories requesting...
The Center for Genomic Interpretation Launches ELEVATEGENETICS VERIFY
Sandy, UT / EIN Newswire / March 21, 2023 – The independent and nonprofit Center for Genomic Interpretation’s (CGI) is launching ELEVATEGENETICS VERIFY™, which is part of the ELEVATEGENETICS® suite of services. The new CGI VERIFY Program helps analyze laboratory...
March 2023 – The Data Driven Point of View
PROBLEM: A government convened workgroup discovered that CLIA mandated proficiency testing is “too easy“. As a result, too many low quality labs with both CLIA & CAP accreditation are issuing too many inaccurate genetic & genomic test results, which are...
Center For Genomic Interpretation Seeks Nominations of ELEVATEGENETICS Acceptable Thresholds Committee
The post Center For Genomic Interpretation Seeks Nominations of ELEVATEGENETICS Acceptable Thresholds Committee appeared first on Center for Genomic Interpretation. The post Center For Genomic Interpretation Seeks Nominations of ELEVATEGENETICS Acceptable Thresholds...
Center For Genomic Interpretation Seeks Nominations of ELEVATEGENETICS Acceptable Thresholds Committee
The post Center For Genomic Interpretation Seeks Nominations of ELEVATEGENETICS Acceptable Thresholds Committee appeared first on Center for Genomic Interpretation. The post Center For Genomic Interpretation Seeks Nominations of ELEVATEGENETICS Acceptable Thresholds...