Goal is to deliver more accurate medical laboratory testing in developing countries to improve quality of care

Picture a point-of-care (POC) device that produces highly accurate HIV results at a lower cost and 10 times faster than traditional ELISA testing currently done by clinical laboratories—then automatically, instantaneously transmits and synchronizes the results with cloud-based electronic healthcare records. This device is a reality and was developed by researchers at Columbia University in New York City.

Pathologists and medical laboratory professionals should know that this POC device was developed specifically to support laboratory-quality HIV-testing in remote areas of developing countries. Its creators want to also revolutionize the ability of patients and consumers worldwide to manage their health.

POC Device Demonstrates Clinical Laboratory-quality Results

“We’ve built a handheld mobile device that can perform laboratory-quality HIV testing, and do it in just 15 minutes and on finger-pricked whole blood,” declared Samuel K. Sia, Ph.D., Associate Professor of Biomedical Engineering at Columbia University’s The Fu Foundation School of Engineering and Applied Science. Sia made the comment in a story by Holly Evarts posted on the university’s website.

Here is the lab-on-a-chip device developed by Samuel K. Sia, Ph.D, and his team at Columbia University. It is capable of doing HIV testing faster and with more accuracy than the HIV ELISA assays currently performed in centralized clinical laboratories and pathology labs. This development is consistent with two important trends. One is the ongoing movement toward faster, cheaper, more accurate point-of-care testing. The other is the growing capability for data sharing and aggregation via cloud-based repositories. The implications are significant for patients and consumers, as well as for the advancement of public health and epidemiology research worldwide. (Photo by Columbia University.)

“[U]nlike current HIV rapid tests, our device can pick up positive samples normally missed by lateral flow tests,” Sia noted. This is significant because weakly positive samples can constitute 0.3% to 3% of HIV-infected patients in high-risk populations, according to a blog post at nature.com.

Sia further noted in the Columbia story that this POC device automatically synchronizes test results with patient health records across the globe by using both cell phone and satellite networks. This allows doctors realtime access to results. Importantly, this automation minimizes user error and user variability, Sia pointed out in the nature blog.

“[W]ith the real-time data upload, policymakers and epidemiologists can also monitor disease prevalence across geographical regions more quickly and effectively,” observed Jessica Justman, M.D., Associate Clinical Professor of Medicine and Epidemiology at Columbia’s Mailman School of Public Health, in the Evarts story. Justman is also Senior Technical Director at Mailman’s International Center for AIDS Care and Treatment Program.

Latest Study Builds on Earlier mChip Technology

In a study published online January 18, 2013, in Clinical Chemistry, Sia described how he and collaborators assessed the device’s ability to perform HIV testing. The team successfully tested over 200 samples of serum, plasma, and whole blood from HIV-infected Rwandans. They then synchronized results in realtime with the patients’ electronic health records (EHR).

The new device builds on a previous work from the Sia Lab. The earlier device was a “lab on a chip” for personal health diagnosis.

Sia collaborated with OPKO Diagnostics, formerly Claros Diagnostics, which was co-founded by Sia. OPKO Diagnostics is a division of OPKO Health, Inc. (NYSE: OPK), a multi-national pharmaceutical and diagnostics company. Together they pioneered the concept for an integrated microfluidic-based diagnostic device. The result was the mChip, which can perform complex laboratory assays cheaply and virtually anywhere. (See Dark Daily, “Rapid HIV Test Could Revolutionize Clinical Laboratory Testing Performed in Developing Nations.”)

Merger Signals Opportunities for Pathologists to Broaden Their Role

Last fall, in a move that is of interest to pathologists, OPKO bought Nashville, Tennessee-based OURLab (Oppenheimer Urologic Reference Laboratory), founded by pathologist Jonathan Oppenheimer, M.D. The merger is an example of an innovative strategy adopted by pathologists that expands their role in therapeutics and pharmaceutical development. (See The Dark Report, “OURLab Founder Lays Out New Business Strategy”.)

Some experts see Sia’s HIV testing device as part of a broader trend. “This is a novel device and the diagnostic field is likely to move in this direction in coming years,” stated Bharat Parekh, Ph.D., a laboratory chief at the Center for Disease Control and Prevention’s (CDC) Division of Global HIV/AID in Atlanta, Georgia, in the nature.com blog. Parekh works on developing rapid HIV testing.

Sia wants to achieve milestones that go beyond access to quality diagnostic testing in developing countries. Going forward, he wants to implement an antenatal care panel for diagnosing HIV and sexually transmitted diseases for pregnant women in Rwanda, Evarts reported. At the same time, on the domestic front, Sia is exploring ways to use the technology for improving healthcare management for patients and consumers in the U.S.

Moving Medical Laboratory Tests into Near-Patient Settings

Sia’s new HIV rapid test technology is further evidence of the evolution of diagnostic testing that will make it possible to move certain medical laboratory tests out of the centralized clinical laboratory and into near-patient settings, including physician offices. Dark Daily readers should not be surprised to see more innovative business pairings, as fundamental changes in the lab marketplace continue to pressure pathologists and clinical laboratory managers to look for novel business strategies.

—Karen Branz

Related Information:

Fast, Low-cost Device Uses the Cloud to Speed Up Testing for HIV and More

Opko Health to buy clinical laboratory company for $40M

Blue-sky HIV test chip will upload results to the cloud

Rapid HIV Test Could Revolutionize Clinical Laboratory Testing Performed in Developing Nations

The Dark Report, “OURLab Founder Lays Out New Business Strategy”