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Cellgen Diagnostics and Genomic Testing Cooperative Partner to Establish a New Standard in Co-Development of Companion Diagnostics for Cancer Therapies

Alliance will enable a faster and more rigorous approach to biomarker
discovery and companion diagnostic co-development

IRVINE, Calif.–(BUSINESS WIRE)–Cellgen Diagnostics, a leading precision diagnostics company, and
Genomic Testing Cooperative (GTC), a pioneer in molecular testing, today
announced a strategic collaboration to help accelerate global
development of companion tests for various oncology therapeutics. The
collaboration, between GTC’s Next Generation Sequencing (NGS),
artificial intelligence (AI) based biomarker discovery service and
Cellgen’s integrated companion diagnostics platform will provide the
pharmaceutical industry a seamless integration of biomarker discovery,
validation and development of in vitro diagnostic companion
assays (IVD).

Companion diagnostics (CDx) enables precision medicine by making sure
the correct person is taking the correct therapies. The companies expect
the first application of their collaboration will be in immuno-oncology
(I-O).

“This collaboration integrates GTC’s extensive experience in biomarker
identification and companion diagnostics development with Cellgen’s
ground-breaking technology to bring unparalleled technical harmonization
to the precision oncology industry,” said Lavance Northington, Founder
and CEO of Cellgen Diagnostics. “Through this industry-leading
partnership, we believe we can improve the pace and pathway of drug
development by showcasing the transformative potential of
immuno-oncology therapies to patients around the world with an offering
that will be unmatched in the industry.”

Cellgen will provide a fully automated companion diagnostic platform
that can be leveraged across multiple drug pipelines. Cellgen Immune
Panel assays will allow pharma groups in R&D to use a standard approach
to patient stratification and therapeutic response monitoring during
clinical trials and into the clinic. Genomics Testing Cooperative
combines next generation sequencing, machine learning and deep-learning
to comprehensively profile the tumor microenvironment and create unique
patient phenotypic profiles. Synergies between both companies will
enable biopharmaceutical companies to make more informed decisions
regarding their immuno-oncology pipelines.

“Genomic Testing Cooperative was established as a diagnostic company
focused on innovation and democratizing the advances in medical
diagnostics through a co-op business model,” said Dr. Maher Albitar,
founder and CEO of GTC. “Cellgen will provide an amplification-free
platform for measuring RNA and testing DNA abnormalities in under 2
hours. We believe this collective approach will be paradigm-shifting for
our pharmaceutical partners because it will reduce the cost and
timeframe of pivotal clinical trials by guaranteeing better patient
classification throughout the drug development process.”

The collaboration will initially focus on next generation sequencing
applications in early-stage clinical programs to allow researchers
comprehensive information from a single sample for molecular
classification. Terms of the agreement have not been disclosed.

About Cellgen Diagnostics

Headquartered in Irvine, California with R&D lab facilities located in
San Diego, California, Cellgen is focused on developing and
commercializing a non-invasive precision medicine platform that can
detect circulating nucleic acids, such as mRNA in white blood cells in
under 2 hours. Running on its proprietary platform, Cellgen’s disposable
cartridge assays will essentially function as a diagnostic memory stick
that measures the genetic expression of a patient’s immune system to
determine if their immune profile is a match for a particular targeted
treatment. Cellgen’s world class team consists of experienced
diagnostic, clinical and entrepreneurial executives that have unique
insights into the development of a successful start-up enterprise
through initial product launch and venture exit. To learn more about
Cellgen Diagnostics, please visit www.cellgendx.com

About Genomic Testing Cooperative, LCA

Genomic Testing Cooperative (GTC) is a privately-owned molecular testing
company located in Irvine, CA. The company operates based on a
cooperative (co-op) business model. The company offers its patron
members a full suite of comprehensive genomic profiling based mainly on
next-generation sequencing. Molecular alterations are identified based
on rigorous testing with the aid of specially developed algorithms to
increase accuracy and efficiency. The clinical relevance of the detected
alterations is pulled from numerous databases using an internally
developed software. Relevance of findings to diagnosis, prognosis,
selecting therapy, and predicting outcomes are reported to members. The
co-op model allows GTC to make the testing and information platform
available to members at a lower cost because of a lower overhead. GTC
depends on the co-op members for marketing, sales, and billing. For more
information, please visit www.genomictestingcooperative.com

Contacts

Cellgen Diagnostics
Lavance Northington, MBA
CEO
Lavance@cellgendx.com
O:
(949) 285-6888

Genomic Testing Cooperative
Maher Albitar, M.D.
CEO/CMO
malbitar@genomictestingcooperative.com
O:
(949) 540-9421

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