I have devoted a number of previous notes to contract research organizations (CROs) such as Covance and Charles River. In prior notes, I have discussed how Covance has developed a global lab network (see: A Look at the World's Largest Central Laboratory Network). Quintiles now is emulating Covance in this regard but with a slight twist by promoting itself as "the largest wholly owned CAP-accredited laboratory network in the world" (see: Quintiles Central Laboratory in India Receives CAP Certification). Below is an excerpt from the article (boldface emphasis mine):
Quintiles Transnational Corp. today announced that its central laboratory in India has been certified by the College of American Pathologists (CAP). The central lab in Mumbai began supporting clinical trials in the first quarter of 2007...."With the certification of the India laboratory, Quintiles Central Laboratory Services now has the largest wholly owned CAP-accredited laboratory network in the world. This tightly controlled network with CAP- certified laboratories in the US, Europe, South Africa, China, India and Singapore allows us to support global and regional trials in almost every country in the world, [said a Quintiles executive."... In addition to laboratory testing, the Mumbai lab provides project management and logistical support, study specific laboratory kits for sites, local investigator support and samples management, storage and processing using consistent global methods. All laboratory data collected is globally harmonized and included in the Quintiles Laboratory Information Management System (QLIMS) and the protocol-specific database.
I suspect that the U.S. reference labs most likely to operate globally in a manner similar to CROs are those involved in genomic/proteomic testing such as Myriad. However, this segment of the market differs markedly from the CROs. To support medical research in India, Quintiles has set up a central lab in Mumbai where routine tests for regional clients can be performed quickly and inexpensively. Nevertheless, Quintiles and other CROs also need to enable the performance of the same tests in other labs around the world but still within its own lab network. This requires "harmonization" (or normalization) of testing whereby a particular test result can be interpreted using the same reference range regardless of where the test is performed in the network.
With regard to molecular genomic/proteomic testing such as that performed by Myriad that I have discussed in previous notes, I believe that there is little likelihood that such tests will be performed, at least in the short term, in any lab other than the the company's central lab in Salt Lake City. Quality control and performance issue are so critical for such tests that it does not make sense to attempt to operate out of multiple labs. The company will simply scale up the test volume in their home lab as test demand increases. For such esoteric testing, test turn-around-time is also not a critical factor so that a day or two of shipping time is easily tolerated with the final reports quickly returned to clients electronically.
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