Jack Phillips guides Roche Diagnostics in providing IVD solutions for the clinical lab

March 19, 2014

 

Jack Phillips
President and CEO
Roche Diagnostics North America

Professional

President and CEO of Roche Diagnostics Corporate for North America since 2010. Prior to his current role, he held various senior leadership roles at Ventana Medical Systems, a leading cancer diagnostic company and a member of the Roche Group

Education

B.S. in Marketing from Northern Kentucky University

Personal

Jack is an endurance athlete and avid cyclist, and his efforts in the community include his support and leadership of the American Diabetes Association Indiana’s annual Tour De Cure. He is a board member of the United Way of Central Indiana and board president of a recently incorporated not-for-profit focused on reducing childhood obesity in Indiana.

Roche Diagnostics’ primary areas of expertise. We focus on the development of medical tests that provide information to help healthcare professionals find the right treatment for patients and deliver the best patient care to improve, prolong, and save lives. We offer a wide range of research and in vitro diagnostic tools that help in the early detection, prevention, diagnosis, and treatment of diseases such as congestive heart failure, HIV, hepatitis, and diabetes, as well as medical conditions such as infertility and blood coagulation. 

Major categories of solutions that Roche Diagnostics provides. We offer labs products and services in four key areas. Our Professional Diagnostics division develops clinical chemistry, immunoassay, and other types of analytical systems, ranging from high-volume automated analyzer systems and workflow solutions to small, handheld meters and portable benchtop analyzers. Our Molecular Diagnostics division develops nucleic acid tests in virology, women’s health, microbiology, genomics, and oncology, as well as blood screening tests that help safeguard the nation’s blood, organ, and tissue supply. The portfolio is based on polymerase chain reaction (PCR) technology. Roche’s Tissue Diagnostics division offers cancer research and diagnostics solutions designed to enable anatomic pathologists and lab professionals to increase testing efficiency. The Ventana portfolio includes products and services for H&E, immunohistochemistry and in situ hybridization, special stains, advanced workflow, and digital pathology. Finally, the Diabetes Care division develops blood glucose monitoring systems. Handheld blood glucose monitors, test strips, insulin pump systems, infusion sets, and data management tools help people manage their diabetes.

Responding to a changing healthcare landscape. The IVD landscape has changed dramatically in the past few years, with the advent of healthcare reform, the rise of ACOs, a growing emphasis on evidence-based medicine and reimbursement tied to outcomes, and lab and hospital network consolidation. This rapid evolution has had an impact on labs, healthcare providers, payers, and patients alike.

Several years ago, Roche stepped into the forefront of a movement that has begun to revolutionize the practice of medicine by helping to address many of the concerns that are driving change in the healthcare market. Personalized medicine, or personalized healthcare (PHC), means fitting the treatment to the patients—providing the right therapy for the right group of people at the right time. We believe that PHC is a key enabler of clinically differentiated medicine, and that it will deliver robust and sustainable value to all members of the healthcare system. 

Companion diagnostics—tests designed to identify the patient population most likely to benefit from a specific therapy—are a big part of personalized medicine. In 2011, Roche introduced the first drug and companion diagnostic to be approved at the same time by the FDA, in this case a test and therapy for a specific BRAF genetic mutation related to metastatic melanoma. The vast majority of new therapies being developed by Roche now have a companion diagnostic in parallel development because this model offers such substantial medical value, tied directly to clinical outcomes. 

So our focus moving into the future is twofold: improving the medical value of diagnostic tests for healthcare providers and their patients and increasing testing efficiency for labs. We also continue to develop and enhance point of care solutions for accurate, fast diagnostic testing in the hospital, clinic, and physician office settings.

Roche has submitted filing to the FDA for cervical cancer primary screening indication for the cobas HPV test. Approval of the expanded indication would mean the cobas HPV Test could be used first-line as part of a cervical cancer screening strategy. The filing includes an analysis of various screening algorithms and three-year follow-up data from the ATHENA study, Roche’s landmark U.S.-based registration trial, including more than 47,000 women screened for cervical disease. If approved, the cobas HPV Test would be the first HPV test approved for primary screening in the U.S.

One factor driving the investigation of a potential primary screening role for HPV DNA testing is its superior sensitivity—greater than 90%. This high sensitivity is consistent with parameters for disease screening protocols in general: use the most sensitive test for first-line screening and a more specific test for triage of abnormal results.

What makes recent findings about HPV testing particularly compelling in the context of cervical cancer screening is that they address the central question that applies to the vast majority of women being screened: Am I really safe until the next round of screening? The answer suggested by the data is a resounding yes: a negative HPV test result provides confidence that a woman will not develop disease in the next five years. 

The established evidence for the value of HPV DNA co-testing has already begun to transform clinical guidelines for cervical cancer screening in the U.S. and around the world. The newer data supporting its potential value in a primary screening role have begun to change clinical practice globally as well—with the main drivers being improved cost savings and patient safety by reducing the frequency of testing while simultaneously finding more precancerous lesions that can be treated.