The #FDA released a statement today ALERTING laboratory personnel and healthcare providers about #Illumina cybersecurity vulnerabilities. Illumina supplies the majority of genomic laboratories with instrumentation to sequence DNA. The letter to healthcare providers...

--------------- FDA WARNING to patients and healthcare providers published yesterday! Non-invasive prenatal screening (NIPS, also referred to as NIPT) is widely used but “none have yet been authorized, cleared, or approved by the FDA. The accuracy and performance of...

--------------- 𝗙𝗗𝗔 𝗢𝗩𝗘𝗥𝗦𝗜𝗚𝗛𝗧 𝗡𝗘𝗘𝗗𝗘𝗗 𝗦𝗢 𝗟𝗔𝗕 𝗧𝗘𝗦𝗧𝗦 𝗗𝗢 𝗠𝗢𝗥𝗘 𝗚𝗢𝗢𝗗 𝗧𝗛𝗔𝗡 𝗛𝗔𝗥𝗠  𝐓𝐡𝐞 Center for Genomic Interpretation (CGI) 𝐬𝐮𝐩𝐩𝐨𝐫𝐭𝐬 𝐭𝐡𝐞 𝗩𝗔𝗟𝗜𝗗 (𝗩𝗲𝗿𝗶𝗳𝘆𝗶𝗻𝗴 𝗔𝗰𝗰𝘂𝗿𝗮𝘁𝗲, 𝗟𝗲𝗮𝗱𝗶𝗻𝗴-𝗲𝗱𝗴𝗲 𝗜𝗩𝗖𝗧 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁) 𝗔𝗰𝘁. This bill was introduced in Congress in December 2018, but is picking...

--------------- Genetic and genomic testing is NOT regulated by the FDA.  Whether your patients or loved ones are being tested for cancer, prenatal testing, rare diseases, etc., a Laboratory Developed Test (LDT), which 99% of genetic and genomic tests are today,...

--------------- “Researchers at City of Hope question the reliability and utility of Natera’s Signatera, highlighting the results as evidence that genomic minimal residual disease (MRD) testing may be at BEST unhelpful and at WORST unreliable in detecting recurrences...