DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics
company, today announced that the U.S. Food and Drug
Administration (FDA) granted Emergency Use Authorization (EUA) for
its QuantiVirusTM MPXV test, which is a PCR test for the
qualitative detection of DNA from monkeypox virus (MPXV) in lesion
swabs collected from individuals suspected of monkeypox infection.
The test is designed for use by authorized
laboratories on the most popular qPCR instruments, including the
Thermo Fisher (ABI) QuantStudio5, Thermo Fisher (ABI) 7500 Fast Dx,
Bio-Rad CFX384, and Roche LightCycler 480 II Systems.
QuantiVirusTM MPXV test targets two different
regions of the MPXV genome, following recommendations from the CDC,
which are both less prone to mutations than other parts of the
genome. This dual-target approach is designed to help QuantiVirusTM
MPXV continue to detect the virus even if a mutation occurs in one
of the target regions.
“I am very proud of our speed, dedication and
ability to develop the QuantiVirusTM MPXV test, which now places us
at the forefront of combating potential problems from Monkeypox,”
said Adam (Aiguo) Zhang, CEO of DiaCarta. “When cases of the
Monkeypox virus infection were initially reported, DiaCarta quickly
allocated resources to develop a test kit that could meet the
testing needs and provide an easy, safe, and reliable testing
solution. Through our proprietary technology, we developed the
QuantiVirusTM MPXV test as a high-throughput solution on an open
qPCR system to better serve patients and healthcare providers.”
The high-throughput solution on an open qPCR
system allows labs to more easily adopt the test and helps
individuals get accurate results quickly, eliminating instances of
unnecessary additional testing or isolation and allowing patients
to have access to appropriate treatment as soon as possible.
About monkeypoxSymptoms of
monkeypox include fever, chills, headaches, muscle aches, fatigue,
swollen lymph nodes and a painful rash that characteristically
appears as raised bumps on the skin and tends to be distributed on
the face, extremities, and genitals. As the disease progresses,
these bumps fill with pus and fluid and become umbilicated. They
will eventually ulcerate, scab, and fall off.
About DiaCarta
DiaCarta is a molecular diagnostics company that
has developed innovative technologies to transform patient care by
providing effective precision diagnostics using liquid biopsy. Its
novel XNA technology is designed to provide a high level of
sensitivity as it binds to the wild-type sequence, to enable only
the mutant target sequence to be amplified. Using this technology,
DiaCarta has developed its ColoScape™ colorectal cancer mutation
test. Powered by its SuperbDNA™ technology that amplifies the
signal and requires no RNA/DNA extraction or amplification,
DiaCarta has developed its RadTox™ test to personalize radiation
and chemotherapy, mitigate adverse events and enhance patient care.
Based in Pleasanton, California, DiaCarta is ISO certified,
GMP-compliant, and offers CLIA certified laboratory services to its
customers. www.diacarta.com
On October 14, 2022, DiaCarta and HH&L
Acquisition Co. (NYSE: HHLA), a special purpose acquisition
corporation, entered into a definitive business
combination agreement that would result in DiaCarta
becoming a public company.
Important Additional Information Will Be
Filed with the SEC
This communication relates to the proposed
business combination between HH&L and DiaCarta (the “Business
Combination”). HH&L has filed a preliminary, and will file a
definitive, proxy statement, which will include a prospectus, which
will be a part of a registration statement, and other relevant
documents with the SEC. This communication does not contain all the
information that should be considered concerning the proposed
Business Combination and is not intended to form the basis of any
investment decision or any other decision in respect of the
Business Combination. HH&L’s and DiaCarta’s shareholders and
other interested persons are urged to read the proxy
statement/prospectus and any other relevant documents filed with
the SEC when they become available, and any amendments thereto,
because, among other things, they will contain updates to the
financial, industry and other information herein as well as
important information about HH&L, DiaCarta and the contemplated
Business Combination. When available, the definitive proxy
statement/prospectus and other relevant materials for the proposed
Business Combination will be mailed to shareholders of HH&L as
of a record date to be established for voting on the proposed
Business Combination. Shareholders will be able to obtain a free
copy of the proxy statement/prospectus (when filed), as well as
other filings containing information about HH&L, DiaCarta and
the proposed Business Combination, without charge, at the SEC’s
website located at www.sec.gov or by directing a request to:
HH&L Acquisition Co., Suite 2001-2002, 20/F, York House, The
Landmark, 15 Queen’s Road Central, Central, Hong Kong. Investment
in any securities described herein has not been approved or
disapproved by the SEC or any other regulatory authority nor has
any authority passed upon or endorsed the merits of the Business
Combination or the accuracy or adequacy of the information
contained herein. Any representation to the contrary is a criminal
offense.
Forward-Looking Statements
This communication contains certain statements,
estimates, targets, forecasts, and projections with respect to
HH&L or DiaCarta. All statements other than statements of
historical fact are forward-looking statements. Forward-looking
statements include, without limitation, statements regarding the
estimated future financial performance and financial position of
DiaCarta. Future results are not possible to predict. Opinions and
estimates offered in this communication constitute DiaCarta’s
judgment and are subject to change without notice, as are
statements about market trends, which are based on current market
conditions. You can identify these forward looking statements
through the use of words such as “may,” “will,” “can,”
“anticipate,” “assume,” “should,” “indicate,” “would,” “believe,”
“contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,”
“point to,” “project,” “predict,” “could,” “intend,” “target,”
“potential” and other similar words and expressions of the future,
but the absence of these words does not necessarily mean that a
statement is not forward-looking. Such forward-looking statements
are based on estimates, assumptions and factors that are inherently
uncertain, that are beyond DiaCarta’s control or ability to predict
and that could cause actual results to differ materially from
expected results. As a result, they are subject to significant
risks and uncertainties and actual events or results may differ
materially from these forward-looking statements. No reliance
should be placed on, any forward-looking statements, including any
projections, targets, estimates or forecasts contained in this
communication. Any forward-looking statement speaks only as of the
date on which it was made, based on information available as of the
date of this communication, and such information may be inaccurate
or incomplete. Products described by DiaCarta in its pipeline are
under investigation and have not been proven to be safe or
effective, and there is no guarantee any such product will be
approved in the sought-after indication or will meet the
developmental milestones set forth herein, including within the
timeline set forth herein. Neither DiaCarta, nor HH&L
undertakes any obligation to release any revisions to such
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law. Information
regarding performance by, or businesses associated with, our
management team or businesses associated with them is presented for
informational purposes only. Past performance by DiaCarta’s
management team and its affiliates is not a guarantee of future
performance. Therefore, you should not rely on the historical
record of the performance of DiaCarta’s management team or
businesses associated with them as indicative of DiaCarta’s future
performance of an investment or the returns DiaCarta will, or is
likely to, generate going forward.
Participants in the Solicitation
HH&L and its directors and executive
officers may be deemed to be participants in the solicitation of
proxies from HH&L’s shareholders in connection with the
proposed Business Combination. A list of the names of HH&L’s
directors and executive officers and information regarding their
interests in HH&L is contained in HH&L’s Annual Report on
Form 10-K, which was filed with the SEC on March 30, 2022, and is
available free of charge at the SEC’s website at www.sec.gov, or by
directing a request to HH&L Acquisition Co., Suite 2001-2002,
20/F, York House, The Landmark, 15 Queen’s Road Central, Central,
Hong Kong. Additional information regarding the interests of any
such participants will be contained in the proxy
statement/prospectus for the proposed Business Combination when
available.
DiaCarta and its directors and executive
officers may also be deemed to be participants in the solicitation
of proxies from the shareholders of HH&L in connection with the
proposed Business Combination. A list of the names of such
directors and executive officers and information regarding their
interests in the proposed Business Combination will be included in
the proxy statement/prospectus for the proposed Business
Combination when available.
The definitive proxy statement/prospectus will
be mailed to shareholders as of a record date to be established for
voting on the proposed Business Combination when it becomes
available. Shareholders, potential investors and other interested
persons should read the proxy statement/prospectus carefully when
in becomes available before making any voting or investment
decisions.
No Offer or Solicitation
This communication is for informational purposes
only and does not constitute (i) a solicitation of a proxy, consent
or authorization with respect to any securities or in respect of
the Business Combination, (ii) an offer or invitation for the sale
or purchase of the securities, assets or business described herein
or a commitment of HH&L, DiaCarta or any of their respective
subsidiaries, stockholders, affiliates, representatives, partners,
directors, officers, employees, advisers or agents, with respect to
any of the foregoing, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction, and this press release
shall not form the basis of any contract, commitment or investment
decision and does not constitute either advice or recommendation
regarding any securities.
Company Contact:Anne Vallerga PhD, MBAVP, External
Affairsannek@diacarta.com
PR Contact:Jennifer SparanoVP, Public
Relationsjsparano@peregrinemarketaccess.com
Investor Contact:Cody Slach, Matthew HauschGateway Investor
Relations(949) 574-3860DiaCarta@GatewayIR.com
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