QIAGEN is expanding its presence in the personalized healthcare field through regulatory submissions, such as two completed in mid-2011 in the United States for the KRAS biomarker that are the result of an extensive range of research and development partnerships. It most recently announced a new assay, its therascreen EGFR Mutation Detection Kit RGQ in Japan. That tool detects genetic mutations to identify patients likely to experience a positive outcome with EGFR-inhibitor drugs targeting NSCLC. EGFR, the epidermal growth factor receptor, has been shown to play an important role in certain cancers and is the target of many new anticancer drugs.  

 

QIAGEN’s reps call this a milestone for the company’s personalized healthcare strategy, as Japan is one of the world’s largest markets for companion diagnostic tests. In April 2011, QIAGEN’s therascreen KRAS Mutation Detection Kit was approved in Japan, targeting a different biomarker that is also used to guide cancer treatment decisions. The potential patient population alone in Japan for EGFR and KRAS testing is estimated at approximately 100,000 per year.  

 

Next up for the company? QIAGEN also acquired the French diagnostics company Ipsogen last year, gaining rights to a portfolio of biomarkers including JAK2 and BCR-ABL that are believed to play a role in various blood cancers.  

 

“Greater use of companion diagnostic tests such as our EGFR and KRAS assays may help overcome significant challenges by maximizing the efficacy and safety of therapies and improving patient outcomes,” says Dr. Steve Little, vice president of global personalized healthcare at QIAGEN. “Japanese and other East Asian populations generally have a higher rate of EGFR mutations than other groups, and non-smoking East Asian women are the largest potential market for EGFR-inhibitor anticancer drugs. This approval allows QIAGEN to market our companion diagnostic along with major pharmaceutical companies offering certain EGFR-inhibitor drugs.”  

 

And let’s not forget …  

 

Another player of late has been Ventana Medical Systems Inc., a member of the Roche group, which recently launched a strategic collaboration agreement with Bayer Pharma AG for the development of a molecular companion diagnostic test that can help identify patients most likely to benefit from a novel Bayer antibody-drug conjugate (ADC). The deal accompanies other pacts that Ventana has inked with Pfizer and Sydndam Pharmaceuticals.  

 

And in the lung cancer space, Ventana is also developing the first fully automated and standardized immunohistochemistry companion diagnostic test for anaplastic lymphoma receptor tyrosine kinase (ALK) gene rearrangements. The test will identify NSCLC patients with ALK gene rearrangements who may benefit from Pfizer’s Xalkori, the drug approved for use in the United States last August.  

 

Where do we go from here?  

 

Infectious disease testing is at least 60 percent of the molecular diagnostics market, says Tan, but the general diagnostics industry is undergoing a huge amount of change in regulatory, reimbursement, coding and healthcare areas. Overall, she adds, the general expectation is that reimbursement levels will continue to fall for all diagnostics, and that the molecular diagnostic segment isn’t immune.  

 

QIAGEN’s Little says that what’s significant is that it’s difficult for a diagnostics company to do all the work themselves from a clinical perspective—that’s why importation partnerships are key.  

 

“The industry has begun to believe in using diagnostics to identify patient responders,” he says. “After several years of slow movement, the pharmaceutical industry has begun to believe that. We are somewhat hampered by not doing clinical trials ourselves—ideally, an objective randomized clinical trial,” he says. “With our global reach, QIAGEN has become a company of choice for drug companies.”  

 

Little concludes by adding that, while the bulk of his company’s partnerships are in oncology, he says its next important area is in inflammatory disease. QIAGEN is also working in the neurology and psychiatry spaces.  

 

Insurance reimbursements aside, Tan says the ability to stratify patients with companion diagnostics, no matter the disease, is driving the healthcare field closer to personalized medicine. Embracing the concept that people respond differently to potential therapies and that some of that response is tied to the genetic makeup of the individual is a huge stride.

 

Truly personalized medicine, she surmises, would be at the individual genome level. For that to happen, she opines that that would have to wait for NGS to get cheaper and for clinical researchers to be able to pull out the clinically relevant conclusions.  

 

“We probably don’t even want this granularity—we pretty much want clear conclusions to be able to make effective actions,” she says. “I think the most important role of companion diagnostics in the industry today is to help change the low valuation of diagnostics in health management. What I mean by this is that people are generally willing to pay a lot of money for life-saving drugs, but the diagnostics are so cost-sensitive. Changing the cost-sensitive nature of in-vitro diagnostics is so critical as the current dynamics of the industry is leading to a decreasing trend in reimbursement for laboratory tests.”  

 

Over at Roche, Wasserman says the company’s development pipeline in the cancer space is full.   “There are currently 20 projects in oncology that have a diagnostic test component as part of their development,” Wasserman says. “Although for some of these projects, we would likely use a test already available, and due to anticipated attrition in the pipeline, we would not expect all 20 projects to make it to the market.”   INC Research’s Kenny says progress in this area is “nothing short of remarkable.”  

 

“We’re not curing people overnight, but if we can get more people to a stable condition more quickly, it’s wonderful,” he says.