Talis Provides Update on Regulatory Pathway for Emergency Use Authorization (EUA) of its Talis One™ COVID-19 Test
March 08 2021 - 8:00AM
Talis Biomedical Corporation (Nasdaq: TLIS), a company
dedicated to developing innovative molecular diagnostic tests for
infectious diseases at the point-of-care, today announced that it
has withdrawn its current application pursuing U.S. Food and Drug
Administration (FDA) Emergency Use Authorization (EUA) for the
Talis One™ COVID-19 test in the CLIA moderate setting, in favor of
focusing on its planned EUA application in the CLIA waived setting.
In late February, the FDA informed the company that it cannot
ensure the comparator assay used in the primary study has
sufficient sensitivity to support Talis’s EUA application.
Talis intends to initiate its previously planned clinical
validation study in a point-of-care environment, with plans to
submit an EUA application for the Talis One COVID-19 test in CLIA
waived settings early in the second quarter of 2021. The planned
clinical validation study was designed with a different comparator
assay, which Talis believes will address the FDA’s concerns.
“The company’s business priority remains focused on serving
health care providers and their patients in the point-of-care
setting, where we continue to see the greatest need for high
quality testing,” said Brian Coe, Chief Executive Officer of Talis.
“Given the recent correspondence from the Agency and its stated
prioritization of point-of-care platforms, we feel this course of
action offers a faster path to market.”
About Talis
Talis is dedicated
to transforming diagnostic testing by developing and
commercializing innovative products that are designed to enable
accurate, low cost and rapid molecular testing for infectious
diseases at the point-of-care, beginning with COVID-19. The company
is developing Talis One, a compact, sample-to-answer,
cloud-enabled, molecular diagnostic platform. Talis is
headquartered in Menlo Park, California. For more information,
please visit talis.bio.
Forward Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts are “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. Words such as
“anticipates,” “focus,” “pursue,” “will,” “intends,” “potential”
and similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
intended to identify forward-looking statements. These statements
include those related to Talis’ regulatory strategy, including its
intention to prioritize an EUA application for its Talis One
COVID-19 test in CLIA waived settings and its ability to submit an
EUA early in the second quarter of 2021; and Talis’ ability to
initiate a new clinical validation study and a limit-of-detection
study for its Talis One COVID-19 test in CLIA waived settings, and
the timing thereof. These forward-looking statements are based upon
the Company’s current expectations. Actual results and the timing
of events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks that the
Talis One COVID-19 test that the Company is developing will be
granted an EUA by the FDA; risks that the FDA may require
additional information or data in connection with the Company’s
EUA; risks and uncertainties associated with the costly and
time-consuming development and regulatory approval process and the
uncertainty of success; and those discussed in the sections titled
“Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” in our prospectus
dated February 11, 2021, as filed with the Securities and Exchange
Commission pursuant to Rule 424(b) under the Securities Act 1933,
as amended, which is available on the SEC’s website at www.sec.gov.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
press release. All forward-looking statements are qualified in
their entirety by this cautionary statement, and the Company
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date of
this press release.
Contact:Media & InvestorsEmily
Faucetteefaucette@talisbio.com+1.415.595.9407
Talis Biomedical (NASDAQ:TLIS)
Historical Stock Chart
From Mar 2024 to Apr 2024
Talis Biomedical (NASDAQ:TLIS)
Historical Stock Chart
From Apr 2023 to Apr 2024