TAG:
clia
PerkinElmer Launches Lab Venture in China
CEO SUMMARY: PerkinElmer is the latest U.S. organization to open a clinical laboratory business in China. Last December, it formally opened its new Suzhou PerkinElmer Medical Laboratory. The new lab is located about 60 kilometers (37 miles) west of Shanghai. It will provide neona…
Achieving CLIA, ISO 15189 at Same Time with A2LA
CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…
Did Theranos Turn Over its CLIA Lab Director?
PROBABLY NO SINGLE LAB INDUSTRY STORY OF THE PAST 24 MONTHS has generated a higher level of curiosity among pathologists and lab administrators than that of Theranos, the Palo Alto, California-based company that regularly claims it has the technology, the business model, and the low price strategy ne…
Healthcare Cost Solutions Will Continue to Pinch Lab Industry Revenues in 2015
CEO SUMMARY: Will 2015 turn out to be a watershed year for the clinical laboratory industry? With healthcare cost solutions continuing to squeeze laboratory profits, two federal agencies are pushing forw…
Lab Industry to Confront Major Issues during 2015
CEO SUMMARY: Will 2015 turn out to be a watershed year for the clinical laboratory industry? Not only are two federal agencies pushing forward with initiatives that will touch nearly every medical lab in the United States in the next 12 months, but other equally powerful trends c…
Top 10 2014 Biggest News Stories
Story no.1 SGR Fix by Congress Spawns PAMA; Lab Industry Wary of Law’s Impact ON APRIL 1, PRESIDENT BARACK OBAMA signed into law the Protecting Access to Medicare Act of 2014 (PAMA). As written, it has the potential to be the most impactful federal legislation on the clinical lab industry s…
Attorneys Outline Issues in FDA’s LDT Guidance
CEO SUMMARY: Officials at the FDA believe that CLIA does not go far enough because it does not address the issues of whether laboratory-developed tests (LDTs) have been designed correctly or have been manufactured in accordance with sound standards. Also, CLIA does not include a process to verify…
November 24, 2014 Intelligence: Late Breaking Lab News
Interesting things are unfolding in San Diego with Pathway Genomics, a company with a CLIA lab that offers genetic testing to physicians. On November 12, it was announced that the IBM Watson Group had invested in Pathway Genomics. The two companies said that they are…
Public Comment Started on FDA LDT Regulations
CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…
Theranos Pursues Different Business Plan in Arizona
CEO SUMMARY: Since its big public debut in late 2013, Theranos has been the subject of keen interest and much skepticism among pathologists and clinical laboratory professionals. Theranos is expanding its presence in Phoenix, Arizona. However, as it does, it looks more like a conventional…
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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