Can labs that aren’t regulated by the FDA create whatever “claims” they wish pertaining to the performance of the test? YES! Does this false advertising ultimately hurt patients? YES! A recent article published by GenomeWeb stated...
Everyone from the genetic, genomic, lab, and pharmaindustry should at this point understand that there are “gaps” currently when assuring quality of NGS (Next Generation Sequencing) based testing in CLINICAL laboratory settings. This working...
𝗙𝗥𝗔𝗨𝗗 𝗜𝗡 𝗖𝗟𝗜𝗡𝗜𝗖𝗔𝗟𝗚𝗘𝗡𝗘𝗧𝗜𝗖𝗦 & 𝗚𝗘𝗡𝗢𝗠𝗜𝗖𝗦 𝗹𝗮𝗯𝘀: 𝟭) 𝗦𝗰𝗶𝗲𝗻𝘁𝗶𝗳𝗶𝗰 𝗳𝗿𝗮𝘂𝗱, 𝟮) 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝘀𝗮𝗺𝗽𝗹𝗲 𝗿𝗲𝗰𝗿𝘂𝗶𝘁𝗶𝗻𝗴 𝗳𝗿𝗮𝘂𝗱, & 𝟯) 𝗯𝗶𝗹𝗹𝗶𝗻𝗴 𝗳𝗿𝗮𝘂𝗱. Do you work for a Clinical Genetics or Genomics laboratory that has a test that is reimbursed by the Centers for Medicare & Medicaid...
“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...
June 20, 2023 The Test Wisely transparency survey was received June 1st, 2023. As promised, as of today, June 20th, 2023, updates on the labs that have responded to CGI are as follows: Communication Received that the Laboratory is Working on Completing the...
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