In a recent post, I discussed how Alexion, a pharmaceutical company, was obtaining test results from reference labs in an anonymized format as a means for tracking patient with PNH and aHUS (see: Reference Labs Provide Patient Test Information to Pharmaceutical Company). Such efforts were deemed necessary by the company because patients with these diseases are uncommon while the cost of drug treatment is astronomical. The company was thus highly interested in identifying patients who would potentially require drug treatment. Here's a quote from that previous note:
Seeking a way to fatten thinning profit margins and under the rationale of helping drug companies with research, labs began to sell blinded test results to data aggregators and drug companies. For Alexion, this arrangement started with a lab in Bangor, Maine, called Dahl-Chase, which helped develop the test to detect PNH. It expanded to other regional labs, including Machaon Diagnostics Inc. in Oakland, Calif., as well as national labs such as Laboratory Corp. of America Holdings, known as LabCorp, and Quest Diagnostics.
I have posted a number of notes in the past about companion diagnostics whereby positive tests for specified biomarkers are required by the FDA in order to justify treatment with some expensive drugs (see: Consideration of a Broader Definition for "Companion Diagnostics"; Companion Diagnostics Gains Wider Acceptance in FDA Despite Challenges; An Expanding Definition for Companion Diagnostics; A Closer Look at Companion Diagnostics Strategies; Cancer Immunotherapy Meets Companion Diagnostics). This is to ensure that the use of these drugs is appropriate with the companion test indicating that the drug treatment will be efficacious. Because of the growing relationship between drugs and lab test results, particularly with reference to drugs with high profit margins, pharma companies will certainly continue to create various "relationships" with reference labs.
What is the nature of these relationships to reference labs? First, the pharmaceutical company may develop special expertise in a technology like flow cytometry and will then seek to license its technology to reference labs. Pharma companies may also buy test results from lab directly or through an intermediary like Management Science Associates. Some drug companies might even try to purchase reference labs but this would probably not sit well with the FDA because of COI issues pertaining to companion testing. Therefore, I suspect that the pharma companies would like to keep their access to test results on a more arms-length basis.
An article from 2003 about "Rd-Dx" relationships suggested to me another and compelling reason for a deepening of the relationships between pharmaceutical companies and the diagnostic industry: the identification of new patients at an earlier point in the natural history of a disease (see: How to Make Rx-Dx Alliances Work). This would serve to increase the market for, say, an immunotherapy agent used to treat cancer (see: Screening and Early Detection). Here is the relevant quote from this article:
Rx Dx alliances, by definition, seek to identify new patients for a drug through the use of new diagnostic technologies. Thus, it is important that the partners come up with diagnostic guidelines and standards that will support the new technology. Although pharma companies can and should expect diagnostic partners to lead those efforts, it is important for both companies to work out shared costs in advance of product development.
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