TAG:
genetic test
2021’s Top 10 Lab Stories Confirm Important Trends
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need respons…
Benefits Investigation Is Growing Issue for Genetic Testing Labs
By Robert Michel | From the Volume XXVIII, No. 9 – July 6, 2021 Issue
QUIETLY AND WITH LITTLE NEWS COVERAGE, a new complication is challenging clinical laboratories that offer genetic testing. It involves a steady growth in the number of patients who do a “benefits investigation” before allowing their physician to order a genetic test….
2020’s Top 10 Lab Stories Are Without Precedent!
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
CEO SUMMARY: There are several surprises in The Dark Report’s list of the Top 10 Lab Stories for 2020. Despite the SARS-CoV-2 pandemic dominating every aspect of clinical care, social…
Veritas Genetics to Close Its Testing Operations in U.S.
By Joseph Burns
MAYBE CHARGING CONSUMERS THE LOW PRICE of $599 for a whole human genome sequence is not a winning financial strategy. That’s one possible reason why closely-watched Veritas Genetics of Cambridge, Mass., will stop operations in the United States. It was in July that Veritas annou…
PGx Testing Labs Concerned by FDA’s Statements, Actions
By Mary Van Doren | From the Volume XXVI No. 12 – September 3, 2019 Issue
This is a synopsis of two in-depth articles in the Sept. 3, 2019 issue of THE DARK REPORT (TDR). The full articles are available to members of The Dark Intelligence Group. CEO SUMMARY: Since April, 2019, the federal Food and Drug Administration (FDA) ha…
PGx Labs Concerned by FDA’s Statements, Actions
By Joseph Burns | From the Volume XXVI No. 12 – September 3, 2019 Issue
CEO SUMMARY: Since April, the federal Food and Drug Administration has taken steps that target clinical laboratories that perform pharmacogenetic (PGx) tests. In response to letters from the FDA, some PGx lab companies have stopped reporting data that predicts a patient’s response to ce…
Concerns Raised Over Pharmacogenetic Tests
By Joseph Burns | From the Volume XXVI No. 12 – September 3, 2019 Issue
CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory…
August 12, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 11 – August 12, 2019 Issue
Add eight more laboratories to the list of lab companies whose patient data were breached when the American Medical Collection Agency was hacked. According to HealthITSecurity, in recent weeks, these labs reported breaches of their patient records: Natera …
July 22, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 10 – July 22, 2019 Issue
Another clinical laboratory company disclosed a major breach of its patients’ protected health information (PHI). On July 15, Clinical Pathology Laboratories (CPL), a division of Sonic Healthcare, issued a press release and disclosed that it estimated as many as 2…
March 18, 2019 Intelligence: Late Breaking Lab News
By Robert Michel | From the Volume XXVI No. 4 – March 18, 2019 Issue
Because of a $25 million grant from philanthropist Denny Sanford, the Veterans Administration and Sanford Health will provide free genetic testing to 250,000 veterans by 2022. These will be pharmacogenomic (PGx) tests designed to help VA physicians prescribe medicat…
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Volume XXXI, No. 12 – September 3, 2024
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