[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Notices]
[Page 13487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06306]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Government-Owned Inventions; Availability for Licensing and 
Collaboration; Notification of Q&A Webinar

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The invention named in this notice is owned by agencies of the 
United States Government and is available for licensing in accordance 
with the U.S. Federal Technology Transfer Act of 1986. Related data for 
510(k) submission is available as part of the licensing package. The 
technology and related data are being licensed to achieve expeditious 
commercialization of federally funded research and development. A U.S. 
Provisional patent application has been filed to extend market 
coverage. CDC also seeks collaboration partners with interest in 
adapting the test for different equipment, point-of-care, or more rapid 
processing.

DATES: Individuals interested in this technology opportunity are 
invited to participate in a live question and answer webinar on April 
27, 2018 at 10 a.m. Eastern Daylight Time.

ADDRESSES: Licensing, related data for 510(k) submission, and other 
information pertaining to the technology listed below, may be obtained 
by writing to Technology Transfer Office, Centers for Disease Control 
and Prevention, 1600 Clifton Road NE, Mailstop D-42, Atlanta, GA 30329; 
Telephone (404)639-1330; or email [email protected].

SUPPLEMENTARY INFORMATION: 

Description of Technology

    CDC Trioplex Real-time RT-PCR (Reverse Transcription Polymerase 
Chain Reaction) Assay for Detection of Zika, Dengue, & Chikungunya 
Virus Infections CDC ref. no.: I-009-17 NIH ref. no.: E-081-2017 (See 
https://www.ott.nih.gov/technology/e-081-2017.)
    CDC has developed the Trioplex real-time RT-PCR test to detect 
evidence of Zika, dengue and chikungunya virus infections, all of which 
are spread by mosquito bites from the same Aedes species and cause 
epidemics in more than 100 countries. The real-time RT-PCR assay is for 
qualitative detection and differentiation of RNA (ribonucleic acid) 
from dengue, chikungunya, and Zika viruses in serum, whole blood, and 
cerebral spinal fluid, and for the qualitative detection of Zika virus 
RNA in urine and amniotic fluid. This assay protocol is designed to 
facilitate simultaneous testing for the three viruses using a single 
sample in the same plate well (multiplex). A singleplex reaction 
(measuring one analyte at a time) is also an option for chikungunya, 
and dengue testing if one primer/probe set per well is preferred. The 
test can be run in different modalities and equipment available in most 
laboratories. The test has been designed to minimize the likelihood of 
false positive results. Cross-reactivity for any of the components is 
not expected. The Food & Drug Administration (FDA) issued emergency use 
authorization (EUA) for the Trioplex assay on March 17, 2016. 
Additional information can be found at: http://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM491592.pdf.
    Currently, there are no vaccines or therapeutics commercially 
available for Zika, dengue, or chikungunya virus infections.
    Competitive advantages:

 Currently, there is no multiplex assay on the market that can 
detect Zika, chikungunya and the four dengue subtypes in one test; this 
test will also help assess disease severity in dengue secondary 
infections
 There is no FDA-approved chikungunya PCR test on the market 
and current Zika and dengue tests must be run separately
 This was the first molecular test for Zika to receive FDA's 
EUA

Question and Answer Webinar

    Individuals interested in this technology opportunity are invited 
to participate in a live question and answer webinar on April 27, 2018 
at 10 a.m. Eastern Daylight Time. Individuals must pre-register for the 
session by sending an email to [email protected] by Thursday, April 26, at 1 
p.m. EDT.
    After requesting the registration, participants will receive a 
confirmation of their registration along with access information to 
enter prior to the webinar. Persons interested in this technology are 
strongly encouraged to register for and participate in the webinar.
    A signed Confidential Disclosure Agreement (available under Forms 
at www.cdc.gov/tto) will be required to receive copies of unpublished 
patent applications and other information.
    Inventors: Jorge Munoz-Jordan, Robert Lanciotti, and Gilberto 
Santiago.
    U.S. PCT (Patent Cooperation Treaty) Application No. PCT/US2017/
023021: Filed March 17, 2017.
    (CDC Ref. #: I-009-17; NIH Ref. #E-081-2017--See https://www.ott.nih.gov/technology/e-081-2017.)

    Dated: March 26, 2018.
Sandra Cashman,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2018-06306 Filed 3-28-18; 8:45 am]
 BILLING CODE 4163-18-P