Diagnostic Medicine is on the Forefront

Genetic tests and the new field of pharmacogenomics is getting marketing support from an unlikely source-Pharmacy Benefit Managers (PBM’s). Medco (MHS), a $60B revenue PBM ($26B Market Cap)with over 65M members has been developing a strategy for “personalized medicine” backed by recent acquisitions and partnerships with the Mayo Clinic and Lab Corp. The Medco WEB site targets “poor management of chronic and complex diseases such as diabetes and cardiovascular disease which cause $350B in excess total healthcare costs.” In February Medco acquired DNA Direct, a pioneer in genetics and molecular diagnostic testing with the objective of “improving clinical and financial outcomes”.The financial terms were not disclosed but the acquisition provides Medco with an information management capability  that can link genetic tests with disease while  providing support to both patients and physicians. In January Medco announced the TRC (Therapeutic Resource Center) which will manage its 850,000 patients currently living with cancer and with the aim of “safer and more effective medication use”.

An article in Today’s May 19,2010 WSJ highlighted Medco’s push into this area which covers 220 clients and 10M members with tests for the blood thinner warfarin and the breast-cancer drug tamoxifen. The market for all molecular tests including genetic tests is approaching $6B for 2010:

Medco Makes Push Into Genetic Testing – WSJ.com

Last week we reported that Pathway Genomics had entered a marketing pact with Walgreen for direct-to-consumer gene based tests but postponed the launch after the FDA (see May 10 letter below) and lawmakers began asking questions about the labeling and approval number for the tests.

Letter to Pathway Genomics Corporation Concerning the Pathway Genomics Genetic Health Report

Raygent  published a review article on this nascent field back in 2008 but the technology and marketing has exploded over the past two years.

Raygent » Articles

Leaps in genomic technology such as microarrays and SNP’s have driven a small but  transformative market in molecular tests. Rapidly changing trends are being addressed by many players coming from different directions which will spur each company to upgrade their strategy. Pharmaceutical R&D will need to look at genetics and molecular targets at an early stage of drug development and diagnostic players already in the genetic testing field will need to redefine markets and look for unique partnerships as well as the  regulatory and reimbursement implications. Now that the consumer is becoming more aware of gene- based medicine, demand will grow but many new issues will arise. The FDA is already behind the curve and will need to quickly address the new genetic tests which are done only in CLIA certified central labs. Physicians and payors are busy dealing with more mundane issues like costs and real-time medical issues like infection and trauma.

The synergy between diagnostics and drug therapy is back but what is surprising is that a PBM has come up with a cohesive strategy for disease management linked with genetic testing. Look for deals and partnerships to accelerate.

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