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WHO Updates Essential Diagnostics List

NEW YORK – The World Health Organization today released its second Model List of Essential In Vitro Diagnostics to help member nations identify the most common diseases and diseases that the organization has granted global priority status.

The updated list builds on the WHO's first list, released in May 2018, which comprised 113 types of IVD tests. The new list comprises 122 test categories — 46 general IVD tests for routine patient care and for detecting and diagnosing a wide array of disease conditions; 69 IVDs intended for detecting, diagnosing, and monitoring specific diseases; and seven test categories for the screening of blood donations.

WHO noted that in expanding the second category of tests to 69 IVDs from 55 in the first list, it is including noncommunicable tests with a new section covering cancer tests, as well as a set of general tests, including a new anatomical pathology section.

WHO said 12 tests were added to include the detection of solid tumors, such as colorectal, liver, cervical, prostate, breast, and germ cell cancers, as well as leukemia and lymphomas.

Tests for what WHO considers priority diseases, such as HIV, tuberculosis, malaria, and hepatitis B and C, as well as syphilis and human papillomavirus, remain on the updated list, which now also includes additional infectious diseases prevalent in low- and middle-income countries, such as cholera, and neglected diseases, such as leishmaniasis, schistosomiasis, dengue, and Zika.

The new list is presented in a two-tier fashion, first as tests for community and health settings without laboratories; and as tests for health care facilities with clinical labs.

WHO said that its list of essential diagnostic tests are not meant to be prescriptive — "rather countries should decide which IVDs to select and where to use them, depending on their epidemiology, human resources, and infrastructure."

Additionally, the list should be used as a guide and reference for member countries that are developing or updating their national essential diagnostics lists "within universal health coverage and for selecting and using IVDs," WHO said. United Nations agencies and nongovernmental organizations that support the selection, procurement, supply, donation, or provision of IVDs may also find the list useful, as would industry, as the list can provide information about global health issues.

"The List of Essential Diagnostics was introduced in 2018 to guide the supply of tests and improve treatment outcomes," WHO Assistant Director-General for Medicines and Health Products Mariângela Simão said in a statement. "As countries move towards universal health coverage and medicines become more available, it will be crucial to have the right diagnostic tools to ensure appropriate treatment."

WHO also updated its Model List of Essential Medicines List today.