TAG:
gene sequencing
Veritas Genetics to Close Its Testing Operations in U.S.
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…
Anti-Trust Regulators Opposed Illumina, Pacific Bioscience Deal
IN TWO COUNTRIES, regulators concerned about a possible monopoly of technologies and instruments used in human gene sequencing apparently were a major reason why the $1.2 billion acquisition of Pacific Biosciences by Illumina Corporation will not happen. The two c…
How Labs Can Add Value for Providers, Insurers, Pharma
CEO SUMMARY: For pathologists and clinical, molecular, and genetic testing labs, appropriate reuses of lab data can provide a new source of revenue. Labs that serve as preferred providers of diagnostic testing data can help health systems, ordering physicians, pharmaceutical companies, an…
PGx Testing Labs Concerned by FDA’s Statements, Actions
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
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…
Illumina to Pay $1.2 Billion to Acquire Pacific Biosciences
IT’S AN ACQUISITION THAT BRINGS TOGETHER two different gene sequencing technologies into one firm. On Nov. 1, Illumina, Inc., announced an agreement to acquire Pacific Biosciences (PacBio) for $1.2 billion. This deal will bolster Illumina’s already-dominant posit…
Coming Soon to a Doctor’s Office Near You!
IT’S TIME FOR ALL CLINICAL LABS AND ANATOMIC PATHOLOGY GROUPS to pay closer attention to the advances in genetic medicine and precision medicine. Events are moving even faster than most experts have predicted. As you will read on pages 3-4, two innovative health networks are on the verge of offeri…
More Primary Care Docs Will Offer Genetic Tests
CEO SUMMARY: This summer, both Geisinger Health and Sanford Health will introduce genetic tests designed specifically for use by primary care physicians in their daily practice. This is a significant milestone on the road to wider deployment of precision medicine services. In the case of …
July 9, 2018 Intelligence: Late Breaking Lab News
Wake Forest Baptist Medical Center of Wake Forest, N.C., has been notified by the Centers for Medicare and Medicaid Services (CMS), in a letter dated June 15, that it is back in compliance with Medicare Conditions of Participation. Earlier this year, following inspe…
Key Lab Trends Described At Executive War College
CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery…
CURRENT ISSUE
Volume XXVII No. 9 – June 22, 2020
THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.
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