Disruptive Diagnostics for the (Developing) World
April 26, 2011
Earlier this month, I attended a great MIT Enterprise Forum discussion on new medical devices designed to provide low cost tests far from laboratories or medical centers, in the developing world.
At the meeting, held by the Forum’s Health Care and Life Science Special Interest Group at the British Consulate in Cambridge, former Mass Biotechnology Council President Una Ryan described the paper-based medical testing technology that her new nonprofit enterprise, Diagnostics for All (DFA), has licensed from the George Whitesides Lab, at Harvard.
The technology allows bodily fluid to accumulate in patterns on postage-stamp sized pieces of paper–to be used for multiple tests simultaneously. DFA’s first project, funded in part by the Bill and Melinda Gates Foundation, is a liver function test to monitor the effects of drugs for HIV/AIDS and tuberculosis, to help manage viral hepatitis. Such tests, which ordinarily require laboratory evaluation, will first be sold in convenience stores in Africa at a cost of approximately ten cents each, Ryan said.
Bill Rodriguez, CEO of Daktari Diagnostics, showed a handheld, point of care, battery-operated diagnostics device the size of a small lunch box or portable radio that will first be used to test for AIDS in Africa–at a cost of $1.50 per test–starting next year. He pointed out that while drugs are available to treat the 33 million people worldwide who have HIV– “ten million of them don’t know it.”
Scientia Advisors Partner Arshad Ahmed, who served as moderator, (and is my client) pointed out in a recent blog that emerging markets may have the opportunity to adopt the latest point-of-care products, leapfrogging developed countries, in some instances–and that “emerging markets are where we will see the first application of low cost and inovative disruptive technologies at work.” Launching in the developing world allows companies to test out and market technologies before going through the rigorous approval process required in the developed world.
I was blown away by the prospects for devices like these and asked when and how they will affect the costs and structure of, say, US healthcare–and whether those who make and market our costly technologies will try to keep these new testing devices out. While Ryan, whose nonprofit will have a commercial wing, responded that she does not expect opposition from stakeholders in our current system. But can that possibly be right?
Anita M. Harris
Anita M. Harris is President of the Harris Communications Group, a marketing and public relations firm specializing in health, science and technology industries, worldwide.
In the coming year, pharma can expect:
- Little growth for big caps and fewer big cap company mergers
- Increased focus on therapeutics for niche and orphan diseases
- Accelerated need for prescription/diagnostics combinations, leading to partnerships or acquisitions.
“In our view, most pharma firms’ current approaches for playing in new fields will not succeed—and companies have many difficult decisions to make,” Glorikian writes. “A big question is whether, in making those decisions, they will try to satisfy shareholders’ immediate needs or ensure long-term company health.”
Here’s a link to the complete blog: Pharma in 2011: A Year for Big Decisions
–Anita M. Harris
Scientia Advisors, based in Boston and San Francisco, is a management consulting firm specializing in growth strategies for major and emerging companies in health care, life science, biotechnology and nutrition. Scientia recently launched a practice Pricing and Reimbursement/Market Access .
Anita Harris is president of the Harris Communications Group— an award-winning marketing and public relations firm in Cambridge, MA. HarrisCom also publishes New Cambridge Observer, a blog covering arts, sciences, business, politics and life in and around Cambridge, MA.
Instrumentation Labs’ New Test for Neonates
July 29, 2010
I’ve been working with Instrumentation Laboratory, a Bedford, MA company, to spread the word about its new diagnostic test that helps prevent brain injury in newborns. Newly cleared by the FDA, it’s first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in neonates.
Bilirubin, a toxin, can, in high amounts, lead to irreversible brain injury in neonates. The new tBili assay is performed on IL’s GEM Premier 4000 critical care analyzer. It allows clinicians to receive lab-quality test results in 90 seconds fromwhole blood in the Neonatal Intensive Care Unit (NICU), rather than wait up to an hour for results from the lab, using traditional chemistry methods.
During the first few days of life, the body breaks down fetal red blood cells, producing bilirubin. More bilirubin is produced than the liver can remove, and it remains circulating in the blood.
This results in jaundice, the most common condition requiring medical attention in newborns, present in approximately 70%. However, in 8-10% of newborns, jaundice progresses to severe hyperbilirubinemia. Left untreated, hyperbilirubinemia can quickly evolve into kernicterus, a devastating, irreversible neonatal brain injury.
IL announced that it had received the FDA clearance for the test on Tuesday, at the annual meeting of the American Association for Clinical Chemistry. For more information, check out the Instrumentation Laboratory (US) Web site-http://www.instrumentationlaboratory.com/ilus.aspx .
—Anita Harris
HarrisCom Blog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer and Ithaca Diaries Blogs.