Precipio Signs Exclusive Manufacturing Agreement for IV-Cell™
June 04 2019 - 9:10AM
Specialty diagnostics company Precipio, Inc. (NASDAQ: PRPO),
announced that it has entered into an exclusive subcontracting
manufacturing agreement with diagnostics manufacturing company
Novamed for the production of Precipio’s proprietary IV-Cell media
for an initial term of 3 years. The agreement will provide Precipio
with large-scale production volume of the media, enabling Precipio
to provide cytogenetics laboratories in the US and worldwide with
IV-Cell media to meet their demand.
Novamed is one of only a few companies worldwide
with both substantial and specific experience in the production of
products similar to IV-Cell; and the manufacturing capabilities
necessary to scale up production of the media in large volumes to
meet customer demand, as anticipated by Precipio. Novamed’s
extensive experience providing various reagents to companies such
as Thermo Fisher and Abbott Laboratories, as well as favorable
business terms reached, were all key to its selection as Precipio’s
choice manufacturer.
The lengthy review and negotiation process was
completed this week, following an extensive, in-depth technical,
manufacturing and logistics due diligence, in which Precipio
carefully evaluated Novamed’s capabilities to manufacture and
deliver the IV-Cell media to Precipio’s specifications.
IV-Cell Advantages
Laboratories conducting cancer diagnostics
require cytogenetics testing as part of the diagnostic process of a
biopsy. Part of the process entails a culturing media (a chemical)
used to mimic the growth of cells outside of the body. The current
media sold on the market comprises of a base media, to which other
components are added based on the type of cell to be cultured; it
also limits the process to the culturing of only one cell lineage
at a time.
IV-Cell is a newly designed proprietary media
that includes all components in one bottle, thereby enabling a
laboratory to culture all four cell lineages simultaneously without
having to select a specific cell lineage. This enables the lab to
arrive at a more accurate diagnosis by ensuring that the correct
cell lineage is cultured. Furthermore, it eliminates the need to
purchase and mix the additional components based on the type of
cell lineage to be tested, delivering significant operational and
cost advantages to cytogenetics laboratories.
“The development and launch of a new media which
will impact the diagnostic process, and subsequently the lives of
tens of thousands of patients, is one that must be done carefully
and correctly,” said Ilan Danieli, Precipio CEO. “The search for
the right manufacturer was viewed as critical to the successful
commercialization of our proprietary media and we are confident
that in Novamed we have found the right partner.”
“We are excited to be working with Precipio to
bring to market its novel media,” said Dr. Emil Katz, Novamed CEO.
“Novamed has always prided itself on creating and delivering
meaningful, patient-impacting products, and so IV-Cell fits our
portfolio well.”
About Novamed
Novamed, Ltd. is a privately-owned Israeli
life science company founded in 1995. Since its inception, Novamed
has been committed to the development of innovative, proprietary
diagnostic systems with worldwide marketing potential. Novamed
combines user need for a particular application with a
cost-effective product. Among Novamed products are
numerous FDA-approved products sold in the US and worldwide;
Novamed holds the ISO 13485 certificate required for medical device
manufacturing. For more information, please visit
www.novamed.co.il.
About Precipio
Precipio has built a platform designed to
eradicate the problem of misdiagnosis by harnessing the intellect,
expertise and technology developed within academic institutions and
delivering quality diagnostic information to physicians and their
patients worldwide. Through its collaborations with world-class
academic institutions specializing in cancer research, diagnostics
and treatment such as the Yale School of Medicine and Harvard’s
Dana-Farber Cancer Institute, Precipio offers a new standard of
diagnostic accuracy enabling the highest level of patient care. For
more information, please visit www.precipiodx.com.
Forward-Looking Statements
Certain statements in this press release
constitute “forward-looking statements,” within the meaning of
federal securities laws, including statements related to ICP
technology, including financial projections related thereto and
potential market opportunity, plans and prospects and other
statements containing the words “anticipate,” “intend,” “may,”
“plan,” “predict,” “will,” “would,” “could,” “should,” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
The Company's actual results could differ materially from those
anticipated in these forward-looking statements as a result of
various factors. Factors that could cause future results to
materially differ from the recent results or those projected in
forward-looking statements include the known risks, uncertainties
and other factors described in the Company’s definitive proxy
statement filed on April 19, 2019 , the Company’s Quarterly Report
on Form 10-Q for the quarter ended March 31, 2019 and on the Annual
Report on Form 10-K for the year ended December 31, 2018 as well as
the Company’s prior filings and from time to time in the Company’s
subsequent filings with the Securities and Exchange Commission. Any
change in such factors, risks and uncertainties may cause the
actual results, events and performance to differ materially from
those referred to in such statements. All information in this press
release is as of the date of the release and the Company does not
undertake any duty to update this information, including any
forward-looking statements, unless required by law.
Inquiries:
investors@precipiodx.com
+1-203-787-7888
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