In developing countries, the explicit link between a numerical measurement of damage to an HIV patient’s immune system and access to medicine to reverse that damage has long been a conundrum: When the test itself is out of reach, appropriate treatment remains out of reach as well. Reliant on expensive machines in centrally located laboratories, tests that measure the relevant immune cell — also known as CD4 — counts can take so long to deliver results that patients’ deteriorating health tells the story of their condition while they wait.
Now, with new World Health Organization guidelines making CD4 count measures more essential than ever in arresting both disease and epidemic, the wait is set to get shorter, as short as 10 minutes.
The advance comes with plans to roll out a device from the California-based diagnostic company Zyomyx, which has spent the last six years developing a CD4 counting machine that is small, portable, and as easy to read as a thermometer. It will be relatively inexpensive — between about $500 and $900 for the instrument — and less than $10 per test. The immediate economic savings, with costs currently including investment in diagnostic machines that run from $7,000 to $30,000, as well as the expenses of transporting test samples are a plus, but the greater savings will come with illnesses averted when patients are able to access appropriate treatment when they need it, Zyomyx global strategy director Joanna Sickler said.
In development since 2007 with funding from the Bill and Melinda Gates Foundation, the device is anticipated to be in use in resource poor settings within the next 12 months. Moving that along, Sickler said, was a partnership with antiretroviral drug provider Mylan, which will help distribute the device. The final steps rely on regulatory approvals, including from the U.S. Food and Drug Adminstration, and World Health Organization prequalification, as well as country approvals.
“Now, many clinics can provide treatment but not the diagnostic tests that guide treatment,” Sickler said. “This test will bridge that gap, allowing the diagnostic to go everywhere the treatment will go.”