The diagnostics industry will play a significant role in the Obama administration's just-released national action plan to combat the rise of antibiotic-resistant bacteria, such as CRE, which was implicated in the recent death of at least two patients in Los Angeles and many illnesses nationwide.
One of the plan's 5 prongs is to "advance development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria." It emphasizes the importance of point-of-care, or point-of-need, testing that can be performed during a visit to the doctor and give a rapid result, as opposed to waiting for a week for tests to be carried out in a centralized laboratory.
By 2020, the goal is to develop "authorized" (or FDA-approved) diagnostics that can quickly distinguish between bacterial and viral infections, and also to validate diagnostics that determine the antibiotic-resistance profile of bacteria that are of public health concern.
The industry will also benefit from the increased emphasis on data sharing and attempt to create a national surveillance system for resistant bacteria. For example, the plan calls for the creation of a public health network for resistance testing and a National Sequence Database of Resistant Pathogens.
In addition, by 2020 the feds aim to achieve "routine testing of zoonotic and animal pathogens for antibiotic susceptibility at ten to twenty [National Animal Health Laboratory Network] and [Veterinary Laboratory Investigation and Response Network] member laboratories, using standardized testing methods and data-sharing practices."
The move is not the first effort by the government to fight the overuse of antibiotics and rise of drug-resistant bacteria, but it is unprecedented in size and scope. "It is the boldest move against antibiotic resistance by any U.S. administration ever," Boston University professor Kevin Outterson told The Wall Street Journal.
Although the plan can be met through federal agency action, it requires congressional funding. President Obama's request for an additional $1.2 billion to combat antibiotic resistance has been warmly received by Sen. Lamar Alexander (R–TN), who is influential on healthcare matters, according to The Wall Street Journal.
The diagnostics industry has a large and profitable role to play in preventing the spread of drug-resistant bacteria. "As the global leader in rapid diagnostics for infectious disease, we commend President Barack Obama for establishing a National Action Plan with measurable goals and specific milestones to address the serious threat of antibiotic resistance," said Avi Pelossof, Alere ($ALR) global president for infectious disease, in a statement lauding the initiative. "We look forward to continuing to work with the Administration on initiatives to promote the development of rapid point-of-care tests that, in turn, help reduce the misuse of antibiotics and unnecessary health care spending."
While antibiotics aren't a very lucrative market compared to cancer drugs and those for other therapeutic areas, Merck's ($MRK) buyout of Cubist for $9.5 billion is a sign that Big Pharma wants to be part of the effort too.
Perhaps most importantly, safety scares like that posed by drug-resistant CRE mean that ordinary citizens are more aware than ever of the threat. As President Obama's plan shows, that should be to the diagnostics industry's benefit.
- read the action plan (PDF) | here's a shorter version
- here's the WSJ article (sub. req.)
- here's Alere's statement