Co-Diagnostics, Inc. Files Provisional Patent for Simplified Targeted NGS Library Preparation
April 30 2019 - 6:30AM
Business Wire
Method includes proprietary, single-step
closed-tube NGS library prep in 3 hours or less
Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular
diagnostics company with a unique, patented platform for the
development of molecular diagnostic tests, today announced today
the filing of a provisional patent with the USPTO for its
single-step next generation sequencing (NGS) library preparation
methods and composition, claiming an exclusive privilege and/or
right to practice the invention, which also embodies the use of the
Company’s patented CoPrimer™ technology in the process. The
technology has numerous applications in liquid biopsy and oncology,
agrigenomics, and infectious diseases.
NGS is a powerful DNA sequencing technology enabling
the mapping or identifying of a large number of DNA fragments
simultaneously. The first stage of the NGS process is the library
preparation, which involves generating a collection of DNA
fragments for sequencing. Co-Diagnostics’ proprietary approach to
library preparation covered under the patent filing is a
single-step, closed-tube polymerase chain reaction (PCR) process
taking up to 3 hours with less than 30 minutes of hands-on labor,
compatible with existing platforms such as Ion Torrent and
Illumina. In comparison, traditional methods to prepare an NGS
targeted library generally take several steps, 7-8 hours, and 2-4
hours of labor.
Company CEO Mr. Dwight Egan remarked, “The growth of
sequencing-based research and business opportunities are highly
dependent upon the technological strength of a given sequencing
platform, and researchers at Co-Diagnostics recognized the need for
a method of library preparation to reduce preparation and user
hands-on time. This dramatic reduction in preparation and
laboratory personnel time and resources meets the very distinct
need for increased throughput and reduced costs in NGS research.
The innovation of this proprietary method is a direct result of our
mandate to use lower-cost molecular diagnostics solutions to
improve the quality of life of those to whom the advantages of
cutting-edge technology may have previously been out of reach.
“Furthermore, the application of PCR in this manner falls
outside of the definition of an in-vitro diagnostic according to
the Food and Drug Administration, meaning it is not subject to the
same strict regulatory requirements as those devices,” continued
Mr. Egan. “We anticipate that fewer regulatory concerns will
provide greater near-term domestic revenue opportunities associated
with offering more affordable NGS solutions to the U.S.
market.”
Sequencing is used to study a broad spectrum of genetic
mutations that might be associated with diseases, or to identify
which sequences of a gene that will respond better to certain
therapeutics, including cancer genome and individual cancer
sequencing to enable more precise diagnoses and personalized
treatment. It can be applied to sequencing an entire genome or
targeting and sequencing selected regions of interest. Targeted
amplicon sequencing allows researchers to sequence a subset of
genes or specific genomic regions of interest.
For more information on using this product in your laboratory or
research center, contact Joseph Featherstone, Co-Diagnostics Head
of Business Development, at:
j.featherstone[at]codiagnostics.com
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a Utah corporation, is a molecular
diagnostics company that develops, manufactures and markets a new,
state-of-the-art diagnostics technology. The Company’s technology
is utilized for tests that are designed using the detection and/or
analysis of nucleic acid molecules (DNA or RNA). The Company also
uses its proprietary technology to design specific tests to locate
genetic markers for use in industries other than infectious disease
and license the use of those tests to specific customers.
Forward-Looking Statements:
This press release contains forward-looking statements.
Forward-looking statements can be identified by words such as
"believes," "expects," "estimates," "intends," "may," "plans,"
"will" and similar expressions, or the negative of these words.
Such forward-looking statements are based on facts and conditions
as they exist at the time such statements are made and predictions
as to future facts and conditions. Forward-looking statements in
this release include statements regarding the (i) use of funding
proceeds, (ii) expansion of product distribution, (iii)
acceleration of initiatives in liquid biopsy and SNP detection,
(iv) use of the Company’s liquid biopsy tests by laboratories, (v)
capital resources and runway needed to advance the Company’s
products and markets, (vi) increased sales in the near-term, (vii)
flexibility in managing the Company’s balance sheet, (viii)
anticipation of business expansion, and (ix) benefits in research
and worldwide accessibility of the CoPrimer technology and its
cost-saving and scientific advantages. Forward-looking statements
are subject to inherent uncertainties, risks and changes in
circumstances. Actual results may differ materially from those
contemplated or anticipated by such forward-looking statements.
Readers of this press release are cautioned not to place undue
reliance on any forward-looking statements. The Company does not
undertake any obligation to update any forward-looking statement
relating to matters discussed in this press release, except as may
be required by applicable securities laws.
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Andrew BensonHead of Investor Relations+1
801-438-1036investors@codiagnostics.com
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