Stemina Biomarker Discovery Announces Rebranding of Its Diagnostics Business, New Board Member Kevin Krenitsky, MD, and Progress from Its Clinical Study

MADISON, Wis.–(BUSINESS WIRE)–#ASD–Stemina Biomarker Discovery Inc. today announced it has rebranded its
diagnostics business to more accurately represent its focus on
neurological disorders. NeuroPointDX is transforming diagnosis and
allowing more precise treatment of neurological disorders based on the
patient’s metabolism. The company’s proprietary metabolomics technology
is already being implemented in the largest clinical study ever
conducted of the metabolism of children with autism spectrum disorder
(ASD).

The Children’s Autism Metabolome Project or “CAMP” study has enrolled
more than 200 patients with autism and other neuro-developmental
disorders. The CAMP study has an enrollment goal of 1,500 children ages
18 to 48 months comprised of three groups of children: those with ASD,
others with developmental delay but not ASD, and typically developing
children. An early look at the data from CAMP has confirmed that the
first metabolic subtype of ASD is being identified in the CAMP study
with about the same prevalence and predictivity as was seen in pilot
studies of banked blood samples at the MIND Institute at UC-Davis and
the Arkansas Children’s Hospital Research Institute.

Metabolomics is the study of differences in metabolism between people
like genomics is the study of genetic differences between people.
Metabolomics focuses on identifying normal and abnormal patterns of
small molecules that indicate the presence of illness or disorder.
Altered metabolism in a patient offers more diagnostic and therapeutic
insight based on the patient’s own metabolism.

Stemina also announced that Kevin Krenitsky, MD, former chief commercial
officer and senior vice president of international strategy and chief
operating officer of Foundation Medicine Inc., to the Stemina’s board of
directors. He joined Foundation in June 2011 and was instrumental in
taking the company from a startup organization to a successful IPO in
2013, followed by a $1.2 billion investment by Roche making it the
company’s majority shareholder. Dr. Krenitsky recently joined Opgen Inc.
as president.

“Dr. Krenitsky will be a key contributor to our business strategy for
NeuroPointDX,” said Stemina’s CEO, Elizabeth Donley. “NeuroPointDX will
provide services for neurological disorders that are similar to those
provided by Foundation Medicine for cancer.”

“Just like cancer is a constellation of subtypes, neurological disorders
like autism and schizophrenia have subtypes. Using our biomarker
discovery platform, we have already identified a series of more than 10
potential subtypes of ASD, Donley said. “We expect that our approach
will provide important information for diagnosis and more precise
treatment of ASD and other neurological disorders as well as
opportunities to collaborate with drug developers on targeted therapies
and clinical trials.”

Stemina was awarded a $2.7-million grant from the National Institute of
Mental Health (NIMH) in August 2015 to support the CAMP study. The study
also is supported by a $2.3-million investment from the Nancy Lurie
Marks Family Foundation. Children are being enrolled at the MIND
Institute at the University of California–Davis, Arkansas Children’s
Hospital Research Institute in Little Rock, Vanderbilt University in
Nashville, Cincinnati Children’s Hospital, Nationwide Children’s
Hospital in Columbus, and the Melmed Center in Phoenix. Two additional
sites are joining the study, Children’s Hospital of Philadelphia and the
Lurie Center at Massachusetts General Hospital, and will begin enrolling
patients later this month.

The CAMP study will validate NeuroPointDX’ diagnostic test for ASD from
a small blood sample. NeuroPointDX will leverage the metabolomics
platform technology developed by Stemina for its work in other
neurological disorders. Stemina’s proprietary metabolomics technology is
capable of identifying not only biomarkers associated with disease, but
also metabolite patterns associated with toxicology and cellular
response to drugs or chemicals. Stemina will continue to deliver its
compound safety screening services to pharmaceutical, chemical,
cosmetics and tobacco companies as well as the U.S. Environmental
Protection Agency.

About NeuroPointDX:

NeuroPointDX is a division of Stemina Biomarker Discovery. NeuroPointDX
will use its metabolomics platform and proprietary biomarker database to
diagnose, treat and develop new therapies for neurological disorders.

Visit NeuroPointDX at http://neuropointdx.com/

Stemina Biomarker Discovery:

Stemina Biomarker Discovery was founded in 2007 and is located in
Madison, Wisconsin. Stemina is a biomarker discovery company focused on
diagnosis and individualized treatment of neurological disorders
including autism spectrum disorders. Stemina uses its proprietary
metabolomics platform to identify changes in metabolism that can be
biomarkers more effective diagnosis and treatment of autism and other
neurological disorders. Stemina operates its business in two divisions:
NeuroPointDX focused on developing diagnostic tests for neurological
disorders; and Stemina focused on screening chemicals and compounds for
their potential to cause birth defects if a woman is exposed during
pregnancy.

Visit Stemina at http://www.stemina.com/

Contacts

Stemina Biomarker Discovery
Elizabeth Donley
(608)577-9209
Chief
Executive Officer
bdonley@neuropointdx.com
bdonley@stemina.com