DiaCarta, Ltd. (“DiaCarta”), a precision molecular diagnostics
company, and Nonagen Bioscience Corporation (“Nonagen”), a cancer
diagnostics company, today announced the successful completion of
the validation study of Oncuria® multiplex bladder cancer
immunoassay as a laboratory developed test (“LDT”). DiaCarta also
announced that it has begun receiving patient urine samples for
testing in its CLIA certified lab in Pleasanton, California.
Oncuria is a multiplex protein-based urine test
aiming to provide early and accurate detection, therapy choice, and
disease monitoring of bladder cancer. Oncuria detects
concentrations of 10 proteins associated with bladder cancer in
urine samples. In clinical studies, Oncuria was shown to
have 93% sensitivity and 93% specificity for detecting bladder
cancer. Additionally, Oncuria has demonstrated consistent
sensitivity and specificity across bladder cancer tumor grades and
stages. Oncuria’s accuracy is especially meaningful for detecting
low-grade tumors, which is an area of high unmet need in bladder
cancer management. Oncuria is intended for use, in conjunction
with, and not in lieu of, current standard diagnostic
procedures.
The American Medical Association has issued
dedicated Current Procedural Terminology (CPT®) Proprietary
Laboratory Analyses (PLA) codes—Oncuria Detect 0365U, Oncuria
Monitor 0366U, and Oncuria Predict 0367U—which are effective as of
January 1, 2023.
Oncuria received Breakthrough Device Designation
from the US Food and Drug Administration (FDA) in September 2021
for predicting responses to Bacillus Calmette-Guérin (BCG) therapy,
a first-line treatment for bladder cancer. Oncuria’s predictive
capability is noteworthy given the current shortage of BCG.
Oncuria was developed and patented in the U.S.
and China by Nonagen. DiaCarta has licensed the exclusive right to
offer Oncuria as a LDT testing service in the U.S. and plans to
work with Nonagen to pursue regulatory approvals in the U.S. and
China.
“The results of our collaborative validation
study with Nonagen Bioscience are exciting and showcase Oncuria as
a truly novel test with potential as an aid for the early diagnosis
of bladder cancer, monitoring of tumor recurrence, and predicting
responses to therapy,” said Aiguo (Adam) Zhang PhD, President &
CEO of DiaCarta. “This product complements DiaCarta’s existing
suite of novel liquid biopsy tests, including the RadToxTM cfDNA
test to monitor tumor response, and the ColoScapeTM Colorectal
Cancer test, further strengthening our robust LDT portfolio,”
concluded Dr. Zhang.
“DiaCarta’s expertise in developing oncology
tests using liquid biopsy makes them an ideal lab services partner
for making Oncuria available as a laboratory developed test,” said
Charles Joel Rosser, MD, MBA, chief executive officer at Nonagen
Bioscience. “We are thrilled to be collaborating with DiaCarta to
give doctors a new, highly accurate, and versatile diagnostic tool
to manage bladder cancer.”
About DiaCarta
DiaCarta is a molecular diagnostics company that
has developed innovative technologies that transform patient care
by providing effective precision diagnostics using liquid biopsy.
Its novel XNA technology provides a high level of sensitivity as it
binds to the wild-type sequence, which enables 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 which personalizes radiation and
chemotherapy, mitigates adverse events and enhances 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.
About Nonagen Bioscience
Nonagen Bioscience is a privately-held
biotechnology company that is focused on globally reducing the
burden of cancer with innovative diagnostics. As a physician-led
company, Nonagen Bioscience is committed to bringing to market the
best-in-class, noninvasive diagnostics for cancer detection,
therapy choice, and disease monitoring, so patients can live
better, longer lives. The Los Angeles-based company was founded in
2011 and is currently developing diagnostics for bladder, breast,
and prostate cancers. Pending FDA approval, Nonagen Bioscience
intends to make its bladder cancer test, Oncuria, available as an
in vitro diagnostic. www.nonagen.com.
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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