Personalis Appoints Former Roche Diagnostics and GRAIL Executive Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical Compliance
18 Outubro 2023 - 8:15AM
Business Wire
Bhandari to drive regulatory strategies for
minimal residual disease (MRD) cancer test
Personalis achieves ISO 13485:2016
certification, attesting to its ability to deliver medical devices
and related services of the highest quality
Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomic
testing for precision oncology, today announced the appointment of
Deepshikha Bhandari as SVP, Regulatory, Quality and Clinical
Compliance. With over two decades of industry marketing and
regulatory affairs experience, Ms. Bhandari will help the company
navigate the regulatory requirements for the NeXT Personal® MRD
test. She was most recently VP, Regulatory Affairs at GRAIL, and
previously held senior positions at Roche Diagnostics and Abbott
Vascular.
“We are advancing our ultra-sensitive NeXT Personal® MRD test as
a Clinical Trial Assay (CTA) for our pharmaceutical partners and
Deepshikha will further drive the regulatory FDA path for the
platform,” said Chris Hall, CEO and President of Personalis. “We
are excited to leverage her experience in our space and welcome her
on our executive team. We believe NeXT Personal’s leading MRD
sensitivity optimizes clinical trial enrollment by accurately
segregating ctDNA-negative and ctDNA-positive patients, thereby
enrolling only patients who are at significant recurrence
risk.”
Personalis also announced its receipt of International
Organization for Standardization (ISO) 13485:2016 certification, a
quality system specification that demonstrates the company’s
ability to provide medical devices and related services with
rigorous quality. This certification is a key part of the strategy
to broaden NeXT Personal use in biopharma clinical trials.
Inducement Awards
Between October 15-16, 2023, Personalis' Board of Directors and
its Compensation Committee granted non-qualified stock options to
purchase an aggregate of 107,000 shares of its common stock to five
new employees, including Ms. Bhandari, under Personalis’ 2020
Inducement Plan. The 2020 Inducement Plan is used exclusively for
the grant of equity awards to individuals who were not previously
an employee, or non-employee director, of Personalis, as an
inducement material to entering into employment with Personalis,
pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Personalis
is making this announcement as required by Nasdaq rules. The
inducement stock options granted on October 15, 2023 have an
exercise price of $1.06 per share, which is equal to the closing
price of Personalis’ common stock on October 13, 2023 and the
inducement stock option granted on October 16, 2023 has an exercise
price of $1.15 per share, which is equal to the closing price of
Personalis’ common stock on October 16, 2023. Each inducement
option will vest over four years, with 25% of the shares vesting on
the first anniversary of the grant date and 1/36th of the remaining
shares vesting monthly thereafter, subject to continued service
through each applicable vesting date. The foregoing inducement
awards are subject to the terms and conditions of Personalis’ 2020
Inducement Plan, and the terms and conditions of the applicable
award agreement covering each grant.
About Personalis, Inc.
At Personalis, we are transforming the active management of
cancer through breakthrough personalized testing. We aim to drive a
new paradigm for cancer management, guiding care from biopsy
through the life of the patient. Our highly sensitive assays
combine tumor-and-normal profiling with proprietary algorithms to
deliver advanced insights even as cancer evolves over time. Our
products are designed to detect minimal residual disease (MRD) and
recurrence at the earliest timepoints, enable selection of targeted
therapies based on ultra-comprehensive genomic profiling, and
enhance biomarker strategy for drug development. Personalis is
based in Fremont, California. To learn more, visit
www.personalis.com and connect with us on LinkedIn and X
(Twitter).
Personalis Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements in this press release that are not historical
are “forward-looking statements” within the meaning of U.S.
securities laws, including statements relating to attributes or
advantages of NeXT Personal. Such forward-looking statements
involve known and unknown risks and uncertainties and other factors
that may cause actual results to differ materially from any
anticipated results or expectations expressed or implied by such
statements, including the risks, uncertainties and other factors
that relate to Personalis’ ability to demonstrate attributes or
advantages of NeXT Personal or the Personalis NeXT Platform. These
and other potential risks and uncertainties that could cause actual
results to differ materially from the results predicted in these
forward-looking statements are described under the captions “Risk
Factors” and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” in Personalis’ Annual Report
on Form 10-K for the year ended December 31, 2022, filed with the
Securities and Exchange Commission (SEC) on February 23, 2023, and
its Quarterly Report on Form 10-Q for the quarter ended June 30,
2023, filed with the SEC on August 8, 2023. All information
provided in this release is as of the date of this press release,
and any forward-looking statements contained herein are based on
assumptions that we believe to be reasonable as of this date. Undue
reliance should not be placed on the forward-looking statements in
this press release, which are based on information available to us
on the date hereof. Personalis undertakes no duty to update this
information unless required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231018100004/en/
Investors: Caroline Corner
investors@personalis.com 415-202-5678
Media Contact: pr@personalis.com
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