WHO to Develop Essential Diagnostics List

The World Health Organization is developing an Essential Diagnostics List to help countries create their own national lists of essential diagnostic tests and tools.

The WHO published its list of essential medicines on June 6, and the Expert Committee on the Selection of Essential Medicines recommended that the WHO develop an essential diagnostics list (EDL) as well.

The EDL will provide evidence-based guidance to countries to create their own national lists of essential diagnostic tests and tools, the organization said, noting that the list will “become an “important contribution to universal health coverage. “

Essential drug lists have helped increase access to needed medicines at more affordable prices in developing nations, and WHO expects that the essential diagnostics list will provide the same benefit for needed diagnostic tests.

“It’s clear that treatment of an illness will not be effective if it is not diagnosed correctly,” said Suzanne Hill, WHO director of Essential Medicines and Health Products. “The EDL will be another useful tool to help countries address their disease burden by focusing on evidence-based diagnostic tools.”

By diagnosing disease earlier, the burden of disease can be reduced significantly in many low-income nations. Diagnostics can also identify subpopulations for which certain medicines may be more effective, and toxicity can also be monitored via these diagnostics.

WHO said that early diagnosis has important implications for prognosis for patients, and the committee, “recognized that Member States and countries might seek advice about which technologies to prioritize, how to shift from one technology to another, and which technologies should accompany essential medicines since they are strongly interconnected.”

The EDL list will likely focus on in vitro diagnostics (IVDs) for TB, malaria, HIV and hepatitis B & C first, and then it will expand the list to other disease areas, particularly antimicrobials and non-communicable diseases.

WHO said that TB is one of the top 10 causes of death worldwide. In 2015, 10.4 million people contracted TB, and 1.8 million died from the disease; more than 95 percent of TB deaths occur in low- to middle-income countries.

To lay the groundwork for the EDL, WHO is creating an expert advisory group called SAGE IVD, which will advise the organization on global policies and developing the EDL.

Some of the benefits expected from the EDL are improved patient care, greater capacity to diagnose diseases during outbreaks, increased affordability of tests, improved regulation and quality of diagnostic tests, and strengthened capabilities of national laboratories.

The committee recommended that WHO use the list of essential medicines as a model for developing the EDL process, methodology and transparency.

It also recommended that strong links be maintained between the SAGE-IVD committee and the Expert Committee on Selection and Use of Essential Medicines. It suggested that the EDL “be instrumental in developing medical guidelines as well as laboratory-accreditation schemes.”