Cell Block Device for
Cytopathology and Surgical Pathology Specimens
WSU Tech#: 13-1174
Technology
Summary:
Preparation
of cell blocks is indicated from swaps or collected fluids where cells or small
tissue fragments are examined.
Veterinary sciences and many research labs also need good methodology to
prepare high quality cell blocks with concentrated diagnostic material along the
cutting surface. Current methods
are labor intensive, take a lot of time to perform and require a high degree of
skill.
Low cost, one
time use device for the concentration of diagnostically significant cells /
tissue micro-fragments into a paraffin block with cells concentrated along the
cutting surface. Modular, scalable
Cell Block Preparation Device for use in cytopathology / surgical pathology
laboratories saves in technologist’s hands-on time (up to 25%) and can be
manufactured for relatively low cost (well under $10 per unit when manufactured
in mass)
Adaptability to use variety of cell blocking media
(such as molten warm gels, ambient temperature thrombin-plasma methods etc.)
with different fixation protocols.
Introduces reproducibility in the cellularity of the cell block sections
by using simple steps during the Cell Block Preparation Protocol. The system has an Inbuilt commercially
available AV Marker to assist the histotechnologists to assess and control the
section cutting depth. Time saving,
ease of use, cost saving and ease of interpreting the final stained preparation,
improved interpretation by pathologists leading to enhanced accuracy of
diagnoses and ultimately improved patient
care.
Competitive Advantages
1.
Adaptability to use cell blocking media
(such as molten warm gels, ambient temperature thrombin-plasma methods e.t.c)
and different fixation protocols suitable for needed elective testing such as
immunohistochemistry and molecular studies including
ISH.
2.
Introduce reproducibility in the cellularity of the
cell block sections by using simple steps during the Cell Block Preparation
Protocol.
3.
Inbuilt AV Marker to assist the histotechnologists to
assess and control the section cutting depth. This marker also helps the orientation
of different serial sections on the slide for interpretation of
immunohistochemistry.
Benefit
Analysis:
In the summer of 2011 there were between 6,800 and
7,000 labs doing anatomic pathology work in the US. In 2010, hospital labs represented about
55% of the clinical lab test market; 33% were independent labs, 10% physician
labs, and 2% other. In 2008,
hospital lab revenues increased from the prior year to a total of $30.4 billion
and between 1998 to 2009, the average growth was
6.7%.
Cytopathology, usually a
subspecialty within pathology laboratories, is used to aid in the diagnosis of
cancer, but also helps in the diagnosis of certain infectious diseases and other
inflammatory conditions. Cytopathology is generally used on samples of free
cells or tissue fragments, in contrast to histopathology, which studies whole
tissues. A cytotechnician is
trained in medical examination and identification of cellular
abnormalities. After reviewing
various sources, there were about 6,000 to 7,200 cytotechnologists working in
the US in 2009. This is an
indication of the size of the labor force within the market. The most common cytopathology test is
the Pap Smear test. An estimated
160 million Pap smears are performed in the industrialized world and
approximately 55 million are done in the USA annually. About $1 billion is spent on Pap smear
testing each year in the US alone.
Cytology is also commonly used to diagnose thyroid blood levels, blood
immune cells and associated diseases, urinary tract infections, infectious
diseases, placental and fetal health, kidney function, and many
others.
Preparation of cell blocks is
indicated in many of these specimens for variety of tests including
immunohistochemistry and ever increasing molecular tests. In addition to this,
veterinary sciences and many research labs also need good methodology to prepare
high quality cell blocks with concentrated diagnostic material along the cutting
surface.
Stage of
Development:
Design and validation
Patent
Status:
Through
the Office of Technology Commercialization at Wayne State University, we have
filed an extensive and detailed PCT patent application.
Licensing
Opportunity:
WSU is looking for commercial partners interested in
furthering the validation of this technology and bringing the technology to
market. The inventors would be open
to assist in the generation of SBIR/STTR grants to fund the further development
of this technology.
Contact
for Further Information:
Frank Urban, MS, CBA, BA. email: frank.urban@wayne.edu
Phone (mobile): (734)
355-0730