[Federal Register Volume 81, Number 129 (Wednesday, July 6, 2016)]
[Notices]
[Page 44034]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15890]



[[Page 44034]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The invention listed below is owned by an agency of the U.S. 
Government and is available for licensing in the U.S. in accordance 
with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious 
commercialization of results of federally-funded research and 
development. Foreign patent applications are filed on selected 
inventions to extend market coverage for companies and may also be 
available for licensing.

ADDRESSES: Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702.

FOR FURTHER INFORMATION CONTACT: Information on licensing, and copies 
of the U.S. patent applications listed below may be obtained by 
contacting: Attn. Invention Development and Marketing Unit, Technology 
Transfer Center, National Cancer Institute, 9609 Medical Center Drive, 
Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive copies of the patent applications.

SUPPLEMENTARY INFORMATION: Technology description follows.
    Title of Invention: Improved Fixative for Paraffin-Embedded Tissue 
Samples.

Description of Technology

    Tissues samples collected during medical procedures, such as 
biopsies, are used to diagnose a wide variety of diseases. Before 
diagnosis, patient samples are typically processed by fixation and 
paraffin embedding. This fixation/embedding process is used to preserve 
tissue morphology and histology for subsequent evaluation. 
Unfortunately, most fixative agents damage or destroy nucleic acids 
(RNA and DNA) and proteins, thereby potentially impairing diagnostic 
assessment of tissue.
    Researchers in the National Cancer Institute's Laboratory of 
Pathology have developed an improved tissue fixative solution that is 
formaldehyde-free. This fixative, BE70, significantly improves DNA, 
RNA, and protein biomolecule integrity in histological samples compared 
to traditional fixatives. Additionally, BE70 is compatible with current 
protocols and does not alter tissue processing. In vitro an in vivo 
data are available and the fixative has been tested on paraffin-
embedded samples.

Potential Commercial Applications

     Improves integrity of fixed tissue samples.
     Improves RNA/DNA quality in fixed tissue samples.
     Non-cross linking, improves protein quality.

Value Proposition

     There is substantial interest in new fixatives to replace 
neutral buffered formalin (a carcinogen) as primary fixative agent for 
surgical pathology.
     BE70 overcomes several limitations of other fixatives, 
including cost and disposal issues.
     Could be formulated as a concentrate, and marketed as an 
additive (to be added during dilution of ethanol).

Development Stage

    In vivo data: YES.

Inventor(s)

    Stephen M. Hewitt (NCI), Joon-Yong Chung (NCI), Candice D. Perry 
(Leidos Biomedical LLC).

Intellectual Property

    HHS Reference No. E-139-2015/0-US-01 US Provisional Patent 
Application 62/255,030 (HHS Reference No. E-139-2015/0-US-01) filed 
November 13, 2015, entitled ``Fixative and Methods of Use''.

Publications

    Perry C, Chung JY, et al. J Histochem Cytochem. 2016 May 24; E-pub 
[PMID: 27221702].

Contact Information

    Requests for copies of the patent application or inquiries about 
licensing, research collaborations, and co-development opportunities 
should be sent to John D. Hewes, Ph.D., email: [email protected].

    Dated: June 28, 2016.
John D. Hewes,
Technology Transfer Specialist, Technology Transfer Center, National 
Cancer Institute.
[FR Doc. 2016-15890 Filed 7-5-16; 8:45 am]
BILLING CODE 4140-01-P