Does Quest’s New CDC Pact Signal Bigger Shift Toward Public-Private Health Initiatives?

Hepatitis has been a disease whose progression in the United States has been difficult to pin down. According to data from the U.S. Centers for Disease Control and Prevention (CDC), the etiology of the disease tends to differ with the viral strain. Cases of hepatitis A have generally been declining for 20 years. Reported cases of hepatitis B dropped by nearly two-thirds from 2000 to 2012. However, the hepatitis B trends may be misleading, as a large number of patients exhibit no symptoms at all, sometimes for decades, while their livers are slowly destroyed. And cases of hepatitis C appear to be in an epidemic mode. The number of reported cases increased 75 percent between 2010 and 2012 alone, with many more Americans still undiagnosed. The often stealth manner of hepatitis tends to impact the cost of treating it. If hepatitis is undetected for a long period of time, the options may dwindle to a liver transplant that can cost $500,000 or more, or a regimen of drugs that can approach $100,000. That has prompted the CDC to take a different tack on monitoring the progression of hepatitis and ways to treat it. And laboratory giant Quest Diagnostics has been a beneficiary of that change. In late January, Quest announced that it received a contract from the CDC to provide data analytics to the agency through its Health Trends database. It contains 20 billion de-identified test results compiled by the New Jersey-based national laboratory over the last decade, including reams of de-identified hepatitis data. All of it has been collected through the testing services performed by Quest, and company officials say it is the largest repository of such data ever compiled by a health care organization. “That data will help the CDC look at the general epidemiology (of hepatitis) across the country,” said Rick L. Pesano, M.D., a Quest vice president who serves as medical director of its infectious disease division. The $500,000 pact is minuscule for a company with annual revenue approaching $8 billion, and Quest has entered into similar deals with accountable care organizations and pharmaceutical firms seeking diagnostic expertise. But it’s the first-ever fee-based contract of any kind for hepatitis research awarded by the CDC to a diagnostic information services company. “The innovative collaboration with Quest Diagnostics will allow us to use data analytics to better monitor the implementation of CDC’s testing guidelines and progress toward reducing deaths from hepatitis,” said John W. Ward, M.D., director of the CDC’s viral hepatitis division, in a press release announcing the contract. “Increased testing is critical to ensure that those who are infected with hepatitis receive life-saving care and treatment.” The contract’s tiny size may be more than overshadowed by the implication that laboratories such as Quest and the testing data they have aggregated over the years may play a significant role in combating expensive to treat and ultimately deadly diseases such as hepatitis. It’s a sort of public health-private data partnership that had not really existed in the past. The need for data analytics appears urgent. According to Quest, the company’s annual revenue for performing hepatitis C testing is around $100 million—more than 1 percent of overall revenue—and is growing at a double-digit clip. Quest spokesperson Wendy Bost attributed the growth in part to the recent development of a group of antiretroviral drugs known as direct-acting agents, which are distributed in the U.S. by Gilead under the Harvoni brand and AbbVie as Viekira. Both provide cure rates at above 90 percent, remarkably more effective than the traditional treatment with Interferon, which is able to slow the damage wrought by the virus but not keep it at bay. And while the pharmaceutical firms have come under fire for pricing their products at around $1,000 a pill, that treatment is still a fraction of the cost of a liver transplant. The testing Quest performs can help expedite the start of the drug treatment. And the data Quest is gathering from its testing can help with monitoring how the disease is progressing in the U.S. Under the terms of the pact, the CDC and Quest will scour the latter’s national database for hepatitis A, B, C and E viral infection in American adults. The analysis will extend to screening and confirmatory tests, treatment-guiding genotyping and viral load tests classified by a variety of demographics. These include gender, age group, geography and type of physician. The data will then be used to identify patterns in disease prevalence and help direct the clinical management of patients. The CDC’s Ward approached Quest on this venture, according to Pesano. The company had been developing algorithms to better analyze hepatitis cases, while the agency had recently developed new testing guidelines with the U.S. Preventive Services Task Force that recommended one-time screenings to pretty much the entire Baby Boomer population. “Nearly three million Americans are infected with hepatitis C, and at least half don’t know it,” Ward said in a statement. “We believe that everyone living with hepatitis C should know their status and have access to effective care and discuss with their provider whether treatment using new therapies is right for them. Through innovative public-private partnerships, we are improving the efficiency and effectiveness of surveillance by incorporating electronic data from large commercial labs into our viral hepatitis surveillance efforts.” Pesano also noted that the incidences of hepatitis B are also likely far higher than diagnosed, and this collaboration could help pinpoint where cases are more likely to crop up. Heather Creran, an Atlanta-based health care consultant with a focus on the laboratory sector, said she expected more such arrangements with public agencies “and really all areas of health care, as our nation works to improve the system and reduce costs.” She added that if performed well, “these collaborations could be very powerful.” The CDC is not working solely with Quest on its hepatitis efforts. Ward said in a statement that the agency is also working with LabCorp to make the surveillance of hepatitis A, B and C more timely. And it is working with ARUP Laboratories in Utah and the Mayo Clinic in Minnesota to promote the addition of pregnancy status to requests for hepatitis B testing to help public health authorities provide prevention services to newborns of mothers infected with the virus. Pesano, who noted that he is a clinician at the core, thinks such collaborations can go a long way toward controlling a disease that often flies under the radar in the U.S. I see this as a public health risk for the country,” he said. “Ultimately, it affords an opportunity for people to get tested and get their diagnosis confirmed, match it against (actionable) data and do something about it.” Takeaway: Quest’s contract with the CDC could be the start of a wave of contracts with labs to assist in public health monitoring efforts.