TAG:
gene testing
CMS Cuts BRCA Price by 49% in Response to Competition
IN THE FINAL WEEKS OF 2013, the federal Centers for Medicare & Medicaid Services (CMS) announced that it would reduce the price it pays for the BRCA genetic test by 49%, to $1,438, effective on January 1, 2014. For Myriad Genetics, Inc., this wa…
2013’s Top Ten Lab Stories Point to Tougher Times
CEO SUMMARY: For 2013, the big story was money—or, more accurately, less money for providers. This was not limited to clinical labs and pathology groups, but was equally true of hospitals and physicians. In THE DARK REPORT’S annual lookback at the year’s 10…
Exome Sequencing Next “Big Thing” for Diagnosis
CEO SUMMARY: For disease diagnostics, exome sequencing is not yet routine, but geneticists are getting close. Using this technology, researchers read those parts of the human genome where about 85% of disease-causing mutations reside. By looking only at the regions that encode proteins—…
MedTox, Cleveland Clinic Labs, Apollo PACS, Dell, British Columbia Health
GENOME SEQUENCING TO BE OFFERED BY NORWAY IN NATIONAL HEALTH PLAN HERE’S A MILESTONE ON THE PATH TO PERSONALIZED MEDICINE. Norway is the first nation to announce that its national health system will incorporate whole genome sequencing. Cancer is the target of Norway’s f…
Roche Offers $5.7 Billion To Acquire Illumina Inc.
CEO SUMMARY: Once again, Roche is hunting for gene sequencing and gene analysis technology that can support its goal of being a world leader in gene-based therapeutics and clinical lab testing that utilizes gene tests and molecular diagnostics. Last week, Roche launched a hostile stock te…
NY & Calif. Act to Stop Web Gene Testing Firms
CEO SUMMARY: Events in the past month indicate that a war is developing between Internet-based companies offering genetic tests to consumers and state and federal health regulators. New York state authorities have sent letters to at least 31 such companies in recent month…
New Rules to Boost Cancer Test Accuracy
CEO SUMMARY: Recent developments in breast cancer testing are leading to changes in pathology. Oncologists and pathologists have issued new guidelines regarding HER2 testing and new research suggests changes may be coming for estrogen-receptor testing as well. For the first time, the new …
CYP450 Testing To Have Major Clinical Impact
CEO SUMMARY: Pharmacogenomics, companion diagnostics, “personalized prescription drug therapy”—by any name, use of molecular diagnostics to guide clinicians in the prescribing and dosing of drugs is about to expand exponentially. Some experts predict that CYP450 testing alone will …
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Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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