Bridesmaid No More: It is Time For Diagnostics To Shine


A 41 year old HIV patient sits down with his physician to discuss his options. After a year of diagnostic tests that indicate stable CD4 cell counts, viral load, and creatinine levels, there has been a change. Over the past few months, the patient’s creatinine has crept up to 1.5 milligrams per deciliter of blood, indicating the patient is not tolerating the therapy. The physician orders a switch in therapy, and the toleration of this therapy is reflected in the creatinine level coming down. The patient is monitored more frequently and remains stable for a while, but then tests indicate the patient’s CD4 levels decreasing and his viral load increasing over time, indicating virologic failure. With this updated information, the physician switches the patient’s therapy again, and the patient stabilizes. Through the entire course of care for this chronic infectious disease, these tests are the window into the patient’s health today and in the future, but all too often, they are not recognized for the value they bring to patient care.

The battery of tests used to monitor and inform the treatment paradigm in HIV is not uncommon and in fact, is considered the standard of care, helping to extend the overall quality of life and the average life expectancy of newly diagnosed HIV patients by 20–25 years. This is also an extraordinary example of the evolution of novel diagnostics over a 30-year period, and one that researchers and developers in many disease states, including cancer, strive to replicate.

Upon delivering an HIV diagnosis the physician chooses from over 20 different antiretroviral agents, representing six different drug classes. Routine tests and advanced molecular techniques are used regularly to predict how individual patients will respond to specific therapies, thus increasing the odds of survival. After beginning therapy, patients are routinely monitored with standard and ultrasensitive blood tests every 3–4 months to assess viral load and confirm ongoing viral suppression. Based on the results of these tests, physicians can tailor therapy based on chronic monitoring of this disease.

A prime example of the power of these tests, this evolution of novel diagnostics and their importance in patient care represents the spirit behind the creation of a new, independent industry organization, DxInsights. Launched at BIO 2012 last month in Boston, this new nonprofit’s mission is to educate all healthcare stakeholders, including industry executives, policymakers, payers and healthcare advocates on the power and value of diagnostics and their impact on improving patient outcomes and reducing costs. Founded and supported by executives steeped in diagnostics, it aims to be the go-to source for basic education and resources on diagnostics

In a recent white paper published on the DxInsights website, we put forward the following facts to highlight the value of diagnostics in the healthcare discussion:

Diagnostics represent the foundation of successful healthcare, providing the critical information physicians need to make the best decisions for a patient’s care. Diagnostics are involved in over 60 percent of clinical decision-making but account for only 2 percent of overall healthcare spending. They are needed to focus treatment as drugs are effective only 50 percent of the time they are prescribed, leading to $160 billion in spending on ineffective drugs. And they provide us a strong economic engine, employing more than 500,000 people and resulting in revenues from clinical and research sectors at over $100 billion. Further, in 2010, more than $500 million was raised on public and private markets, and 60 companies were started. In 2011, more than $17 billion in mergers and acquisition values was realized.

Despite these facts and the overall power of the industry, too few stakeholders understand the power of fully informed diagnostics. Too few physicians are totally confident in today’s diagnostic tools, too few policymakers fully appreciate the impact of diagnostics, and too few payers consider diagnostics “money well spent.”

To persuade stakeholders to adopt value-driven diagnostics into the healthcare value chain, we must educate to overcome the inertia around four key barriers:

1. Limited funding for innovation: The venture capital and private equity sectors are hesitant to invest in small companies that develop precision diagnostics and technologies, even though these organizations engender significant innovation.

2. Ambiguous (at best) healthcare regulation: Although the FDA has made strides in developing draft guidelines in recent years, they remain in draft form and thus the future approval pathway for diagnostics and companion diagnostics is unclear.

3. Insufficient reimbursement for diagnostic tests: The current coding and payment systems do not accurately describe novel diagnostics, reflect the value to patients, or account for the need for increased development resources to support strong claims.

4. Slow market adoption of novel diagnostics: Physicians must be educated to put their trust and confidence in diagnostic technologies that demonstrate potential to advance patient care. Education is paramount to accelerate market adoption of these valuable technologies.

The critical need for education to lift these barriers has led to a revolutionary alliance of the diagnostics community. Diagnostic stakeholders have joined together to create DxInsights in order to illuminate providers, policymakers, payers, investors, and patients about the important capabilities of diagnostics available today, ways to lift these barriers through education and research for all stakeholders, and promote the promise of an even greater future. It is time for diagnostics to step out of the shadows and be recognized for the value it brings. It is time for diagnostics to shine.

For more information, please visit the DxInsights website.

Kristin Pothier leads the Diagnostics and Life Sciences Practice at Health Advances, a consulting firm. Follow @

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