SEC. 2. IMPROVING DEVELOPMENT AND DISTRIBUTION OF 
DIAGNOSTIC TESTS. 
Section 319B of the Public Health Service Act (42 
U.S.C. 247d–2) is amended to read as follows: 
‘‘SEC. 319B. IMPROVING DEVELOPMENT AND DISTRIBU-
TION OF DIAGNOSTIC TESTS. 
‘‘(a) DIAGNOSTIC TESTING PREPAREDNESS PLAN.— 
The Secretary shall develop, make publicly available, and 
update a plan for the rapid development, validation, au-
thorization, manufacture, procurement, and distribution 
of diagnostic tests, and for rapid scaling of testing capac-
ity, in response to chemical, biological, radiological, or nu-
clear threats, including emerging infectious diseases, for 
which a public health emergency is declared under section 
319, or that has significant potential to cause such a pub-
lic health emergency. 
‘‘(b) PURPOSES.—The purpose of the plan under sub-
section (a) shall be to— 
‘‘(1) facilitate the development and utilization 
of diagnostic tests; 
‘‘(2) describe the processes for the rapid devel-
opment, validation, authorization, manufacture, pro-
curement, and distribution of diagnostic tests, and 
for rapid scaling of testing capacity; and 
‘‘(3) facilitate coordination and collaboration 
among public and private entities to improve the 
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rapid development and utilization of diagnostic test-
ing during a public health emergency. 
‘‘(c) CONSIDERATIONS.—The plan under subsection 
(a) shall take into consideration— 
‘‘(1) domestic capacity, including any such ca-
pacity established through partnerships with public 
and private entities pursuant to subsection (e), to 
support the development, validation, manufacture, 
procurement, and distribution of tests, and the rapid 
scaling of testing capacity; 
‘‘(2) novel technologies and platforms that— 
‘‘(A) may be used to improve testing capa-
bilities, including— 
‘‘(i) 
high-throughput 
laboratory 
diagnostics; 
‘‘(ii) point-of-care diagnostics; and 
‘‘(iii) rapid at-home diagnostics; 
‘‘(B) improve the accessibility of diagnostic 
tests; and 
‘‘(C) facilitate the development and manu-
facture of diagnostic tests; 
‘‘(3) medical supply needs related to testing, in-
cluding diagnostic testing, equipment, supplies, and 
component parts, and any potential vulnerabilities 
related to the availability of such medical supplies 
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and related planning needs, consistent with section 
2811(b)(4)(J); 
‘‘(4) strategies for the rapid and efficient dis-
tribution of tests locally, regionally, or nationwide 
and appropriate scaling of laboratory testing capac-
ity; and 
‘‘(5) assessment of such strategies through 
drills and operational exercises carried out under 
section 2811(b)(4)(G), as appropriate. 
‘‘(d) COORDINATION.—To inform the development 
and update of the plan under subsection (a), and in car-
rying out activities to implement such plan, the Secretary 
shall coordinate with industry, such as device manufactur-
ers, clinical and reference laboratories, and medical prod-
uct distributors, States, local governmental entities, In-
dian Tribes and Tribal organizations, and other relevant 
public and private entities. 
‘‘(e) CAPACITY BUILDING.—The Secretary may con-
tract with public and private entities, as appropriate, to 
increase domestic capacity in the rapid development, vali-
dation, authorization, manufacture, procurement, and dis-
tribution of diagnostic tests, as appropriate, to State, 
local, and Tribal health departments and other appro-
priate entities for immediate public health response activi-
ties to address an infectious disease with respect to which 
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a public health emergency is declared under section 319, 
or that has significant potential to cause such a public 
health emergency. 
‘‘(f) DEADLINES FOR PLAN.— 
‘‘(1) PUBLIC
RELEASE.—Not later than one 
year after the date of enactment of the Diagnostics 
Testing Preparedness Plan Act of 2025, the Sec-
retary shall publicly release the plan developed under 
subsection (a). 
‘‘(2) UPDATES.—The Secretary shall update 
such plan not less frequently than once every 3 years 
after the date of the initial public release of the 
plan.’’. 
Æ 
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