Freenomes IMPACT Advisory Board Brings Strategic Insight and Real-World Experience to AI-Genomics Cancer Tests

Freenome,
a leading artificial intelligence (AI) genomics company, announced the
creation of its IMPACT Advisory Board, a group tasked with helping
Freenome’s leadership team optimize the company’s short- and long-term
strategies, including those for its first commercial launch.

With a focus on clinical development, regulatory approval, health
economics, coverage and reimbursement, the IMPACT Advisory Board is the
cornerstone of Freenome’s commitment to ensuring that as many patients
as possible have access to and benefit from the first ever, blood-based,
AI-genomic test available for the early detection of colorectal cancer
(CRC).

Guiding regulatory strategy will be Alberto Gutierrez, Ph.D., a
partner at NDA Partners LLC and a former 25-year veteran of the U.S.
Food and Drug Administration (FDA), including six years as Director of
the agency’s Office of In-Vitro Diagnostics (OIVD), a tenure that saw
breakneck advances in the field of molecular diagnostics. Joining Dr.
Gutierrez will be Louis Jacques, M.D., Chief Clinical Officer of
ADVI Health and former head of the Centers for Medicare and Medicaid
Services’ (CMS) Coverage and Analysis Group. He will advise on payer
strategy along with Sherie Smalley, M.D., Senior Medical
Director, Medical Policy, at UPMC Health Plan.

According to Dr. Jacques, “After conversations with representatives of
companies during my years with CMS, I was often left with the feeling
of, ‘I wish they had talked to us two, three, even four years earlier.
We might have been able to give them some advice back then that would
have put them in a better situation now.’ Working with Freenome is an
opportunity to get it right from the very beginning.”

According to Girish Putcha, M.D., Ph.D., Freenome’s Chief Medical
Officer, “With the IMPACT Advisory Board, we’re intentionally
recruiting experts who represent the diversity of stakeholders in the
healthcare ecosystem. This initial group has a proven track record of
safeguarding patients while expediting access — not just to the latest
technologies, but to those with the most significant clinical benefits.”

To advise on clinical development strategy, Freenome has retained expert
gastroenterologists, such as Douglas Robertson, M.D., M.P.H.,
from the U.S. Multi-Society Task Force of Colorectal Cancer (MSTF).
Inclusion in clinical screening guidelines from such organizations is
often an essential step to achieving broadscale coverage and
reimbursement from the nation’s payers.

“In today’s healthcare environment, even the most revolutionary medical
technology can only be transformational if it’s widely reimbursed,” said
Mike Nolan, Chief Commercial Officer of Freenome. “Beginning with that
end in mind was what led us to reach out to the people who understand
that reality better than anyone else.”

About Freenome:

Freenome is an AI genomics company on a mission to empower everyone with
the tools they need to detect, treat, and ultimately prevent their
diseases. By applying advanced machine learning techniques to recent
breakthroughs in genomic science, Freenome is developing noninvasive
blood tests to detect early-stage cancer and improve precision oncology
treatments for millions of patients. The company has raised $78 million
from investors such as Andreessen Horowitz, Google Ventures, Polaris
Partners, and Founders Fund. More information at: https://www.freenome.com/.

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