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.
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.
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.