Abstract
Introduction
As health care moves toward personalized medicine, biomarkers have gained an
increasingly important role in the delivery of effi cient, quality care. The
FDA has established specifi c defi nitions for biomarkers, and diagnostics,
biotechnology, and pharmaceutical companies have woken up to biomarkers'
potential following the publicity surrounding biomarkers associated with
Genentech' s Herceptin. A large number of companies now have commercialized
biomarker tests employing a variety of technologies, and activity is
particularly prevalent in the oncology and drug dosing arenas. Although larger
companies such as Roche have dominated molecular diagnostics, smaller
companies willing to invest in niche product areas have seized the opportunity
to develop equally valuable products.
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- Oncology and infectious diseases have proven to be the most popular
targets of new biomarker development; however, oncology is favored because it
has one specifi c advantage. What is that advantage?
- Although companies have already successfully commercialized oncology
markers in breast cancer, new opportunities lie in other oncology areas. Which
company is developing biomarker tests to detect signs of prostate and colon
cancer, and which company is developing tests to detect the most common causes
of cervical cancer?
- Focusing on generating scientifi c publications and clinical trial data
throughout the development of a new biomarker test can allow for early
commercialization of the test. Which company successfully employed this
strategy to develop and commercialize its biomarker test-now reimbursable
under the insurance plans of 125 million people?
- Increased regulatory oversight may make marketing some types of diagnostic
tests more diffi cult. Which biomarker tests has the FDA specifi cally
suggested it will seek to regulate?
- The approval of Genentech' s Herceptin, requiring the co-development of a
test for HER2/NEU to qualify patients for treatment, has inspired other
companies to try similar co-development strategies. Which companies have
attempted to duplicate Herceptin' s success? Have these companies' attempts
been successful?
- Companies having platform technologies that can provide simpler biomarker
assays capable of being automated have an advantage over those companies that
cannot provide such assays. Which companies have this capability?
- Roche is currently the dominant player in the fi eld of molecular
diagnostics. What types of diagnostic systems have helped Roche to become the
dominant player in this fi eld? What strategies has Roche pursued to improve
on its diagnostics position?
Scope
- Current biomarker technologies: in vitro diagnostic tests (IVDs),
immunohistochemistry (IHC) tests, fl uorescent in situ hybridization (FISH)
tests, microarrays, and circulating tumor cells (CTCs)
- Biomarker diagnostics for targeted cancer therapies: Herceptin and its
companion biomarkers; Genomic Health' s Oncotype DX biomarker test and
Agendia' s MammaPrint test for breast cancer; Veridex' s CellSearch system to
aid monitoring of metastatic breast cancer; biomarker tests to diagnose and
monitor chronic myelogenous leukemia and determine initiation of Gleevec
- Companion biomarker diagnostics for drug dosing: biomarkers for Pfi zer' s
Camptosar and Bristol-Myers Squibb' s Coumadin
- Commercialized biomarker products: successful products from Dako, Roche
Diagnostics, Genomic Health, Agendia, Third Wave Technologies, Genzyme
Genetics, and Veridex
- Opportunities: continued commercialization of oncology biomarkers;
attractions of NAT technology; increasing importance of drug labeling; small
companies' successes; signifi cant room for improvement
- Challenges: the reluctance of drug companies to restrict the use of their
drugs through biomarker tests; uncertain regulatory environment; low
reimbursement rates for diagnostic products; the diffi culties of developing
companion diagnostics for EGFR-targeted drugs
- Outlook: licensing opportunities for smaller players; the advantages of
platform biomarker technologies; reimbursement issues; the launch of
validation and clinical trials; increasing chances of early adoption by
coordinating product development with business strategy
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