October 18, 2021 Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXVIII, No. 14 – October 18, 2021 Issue

One interesting development from the SARS-CoV-2 outbreak is a new ability to collect genetic data on the virus and its variants from a growing number of countries across the globe. The World reported that “In March, the one millionth genomic sequence for the new coronavirus came from Chile; …

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May 3, 2021 Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXVIII, No. 6 – May 3, 2021 Issue

Superman, the superhero of DC Comics and movies, recently gave a positive shout-out to lab professionals during the 45th Annual Lab Week. The American Society of Clinical Pathology (ASCP) gave its Lab Week recognition a theme of “Avengers of…

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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…

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Anti-Trust Regulators Opposed Illumina, Pacific Bioscience Deal

By Joseph Burns

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…

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How Labs Can Add Value for Providers, Insurers, Pharma

By Joseph Burns | From the Volume XXVI No. 15 – November 4, 2019 Issue

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…

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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…

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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…

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Illumina to Pay $1.2 Billion to Acquire Pacific Biosciences

By Joseph Burns | From the Volume XXV No. 17 – December 3, 2018 Issue

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…

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July 9, 2018 Intelligence: Late Breaking Lab News

By Robert Michel | From the Volume XXV No. 10 – July 9, 2018 Issue

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…

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More Primary Care Docs Will Offer Genetic Tests

By Robert Michel | From the Volume XXV No. 10 – July 9, 2018 Issue

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 …

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