TAG:
medical laboratories
Labs May Be Excluded from Revised Stark Law, AKS Rules
This is an excerpt of a 1,460-word article in the Jan. 6, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Here are early insights about a federal compliance reform that has not gotten much attention among clinical la…
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…
In New Mexico, Three Collaborators Improve Patient Care, Outcomes
IT’S OFFICIAL! A YEAR-LONG COLLABORATION involving a health insurer, a clinical laboratory, and an analytics company showed that insurers and physicians can use clinically-actionable intelligence developed from medical lab test data to improve patient outcomes. This important accomplishment in patie…
Labs Should Heed Lessons from Huge Data Breach
CEO SUMMARY: Following news last month about the biggest breach of personal health information in the clinical lab industry, lawyers representing some of the affected patients filed at least 12 class action lawsuits. Federal officials and attorneys general in multiple states also launched…
April 29, 2019 Intelligence: Late Breaking Lab News
Investor interest in digital pathology (DP) and the use of artificial intelligence (AI) to analyze digital pathology images seems to be at a fever pitch recently. In the last three weeks, investors poured almost $85 million of capital into just three digital pathology companies, as noted below. This…
COLA: GAO Should Address PAMA’s Effect on Patients
CEO SUMMARY: In a recent statement, COLA, an organization that accredits clinical labs, expressed strong concern about how a report from the Government Accountability Office did not address how the Protecting Access to Medicare Act of 2014 (PAMA) affects patients’ access to testing, esp…
Sonic to Pay $540 Million to Buy Aurora Diagnostics
CEO SUMMARY: Sonic Healthcare, Ltd., announced that it would pay $540 million—a multiple of 9.2 times EBITDA—to acquire Aurora Diagnostics, the anatomic pathology company based in Palm Beach Gardens, Fla. Sonic will gain 32 pathology practice sites and add 220 pathologists to its netw…
Sonic Uses Lab Data, Patient-Contact Tools, to Improve Outcomes
CEO SUMMARY: In its work for a federally qualified health center, Sonic Healthcare USA helped physicians use a data-driven approach to population health management that incorporated integrated financial and clinical analytics. Also, Sonic developed technologies that give ordering physicia…
Sonic Sees a Future in Lab JVs with Hospitals
CEO SUMMARY: In every partnership, each member has a unique point of view. Following the announcement of a new laboratory joint venture company involving ProMedica Health System and Sonic Healthcare USA, the Sonic executive who worked with ProMedica’s administrators to develop the JV ex…
CURRENT ISSUE
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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