NantHealth Announces FDA Marketing Authorization of Omics Core℠: The Nation’s First Tumor-Normal Mutation Profiling of Ov...
November 12 2019 - 2:15PM
Business Wire
- Landmark FDA clearance of whole exome sequencing in vitro
diagnostic (IVD) test reporting overall tumor mutation burden (TMB)
by sequencing 19,396 protein-coding genes (whole exome) targeting
39 million base pairs (39 Mb) of the human genome from patient
tumor and matched normal sample (tumor-normal), for true
determination of overall TMB, rather than the commonly-used
formulaic extrapolation of TMB from gene panel sequencing.
- TMB, the measure of all acquired gene-coding mutations in a
tumor genome, is an emerging biomarker predicting response to
checkpoint therapy and identifies tumors that may benefit from
immunotherapy.
- Omics Core additionally reports somatic mutations in 468
cancer-relevant genes accurate to 2% allele frequency providing a
means to guide physician treatment decisions.
NantHealth, Inc. (NASDAQ: NH), a next-generation,
evidence-based, personalized healthcare company, today reported FDA
authorization of Omics Core℠, the first whole exome tumor-normal in
vitro diagnostic (IVD) that measures overall tumor mutational
burden (TMB) in cancer tissue.
The Omics Core assay is the nation’s first FDA authorized
custom-targeted whole exome sequencing platform to report both
overall tumor mutation burden in tumor specimens from 19,396
protein-coding genes (whole exome) and somatic alterations (point
mutations, small insertions and deletions) in 468 cancer-relevant
genes.
TMB is reported via two metrics:
- Total number of somatic non-synonymous exonic variants within
the 19,396 genes (whole exome) surveyed.
- An estimate of mutation rate by counting all somatic,
synonymous and non-synonymous variants detected in gene coding
regions and dividing by the approximate size of the whole
exome.
“Tumor mutation burden (TMB) is now recognized as a key
biomarker across multiple tumor types. Studies have shown that
immunotherapy treated patients with high TMB had better outcomes
compared to those with low TMB. Since the potential for TMB as a
precision medicine tool is so high, it is imperative that the most
accurate and comprehensive method of analysis be applied to enable
physicians to determine which tumors could benefit from checkpoint
inhibitors and immunotherapy,“ said Patrick Soon-Shiong, MD,
Chairman & CEO NantHealth. “I am so proud of the scientific,
regulatory and bioinformatics teams who have spent almost a decade
to perfect this important test that measures the absolute number of
mutations occurring in 19,396 protein-coding genes (whole exome)
targeting 39 million base pairs (39 Mb) of the human genome from
both a tumor and patient-matched normal control sample
(tumor-normal). We believe that this comprehensive diagnostic will
provide greater accuracy than the widely-used formulaic
extrapolation of TMB from a limited gene panel sequence ,” said
Soon-Shiong.
“Omics Core is the first whole exome test for TMB authorized by
the FDA, and as such, marks a watershed moment in oncology.
Clinicians can now directly measure the mutations in a patient’s
tumor specimen accurately via tumor-normal sequencing and have
confidence that the results they receive are fully validated to
help support better therapeutic decisions. Also, the breadth of a
whole exome means that many more neoepitopes and novel targets may
be identified to support vaccine development, novel drug
development, and therapies for previously undruggable targets,”
said Sandeep Bobby Reddy, MD - Chief Medical Officer,
NantHealth
“Multiple groups, including our own presentation at ASCO in
2018, have shown the importance of performing whole exome
sequencing to measure the comprehensive TMB. We calculated a
three-fold overestimation of TMB when extrapolating from
panel-based methods, potentially leading physicians to
over-prescribe checkpoint inhibitors for patients that are unlikely
to respond. Given the high cost and the possibility of adverse
events with these therapies, it is critical we identify the most
appropriate population as accurately as possible,” said Steve Benz,
PhD - President, Genomics, ImmunityBio.
“Determining the tumor mutational burden from whole exome
sequencing is the first step in defining neoepitopes. These unique
tumor mutations are recognized by T cells and elicit an
immunological anti-tumor response. Patients with high TMB typically
have more neoepitopes that attract cancer killing T cells to the
tumor microenvironment. Identifying neoepitopes from whole exome
TMB enables the development of neoepitope-targeted vaccines for the
>95% of protein-encoding genes not covered by limited gene panel
tests and the >99% of genes not directly targeted by drugs
today. The clearance of Omics Core based upon its analytical
performance and validity in reporting TMB establishes a new chapter
in the era of precision cancer immunotherapy,” said Shahrooz
Rabizadeh, PhD - Chief Scientific Officer, ImmunityBio.
About Omics Core
The Omics Core assay is a qualitative in vitro diagnostic test
that uses targeted next generation sequencing of formalin-fixed
paraffin-embedded tumor tissue matched with normal specimens from
patients with solid malignant neoplasms to detect tumor gene
alterations in a broad multi gene panel. The test is intended to
provide information on somatic mutations (point mutations and small
insertions and deletions) and tumor mutational burden (TMB) for use
by qualified health care professionals in accordance with
professional guidelines, and is not conclusive or prescriptive for
labeled use of any specific therapeutic product. Omics Core is a
single-site assay performed at NantHealth, Inc. The Omics Core
assay is protected by US Patents 9,652,587; 9,646,134; 9,824,181;
10,249,384; 9,721,062; 10,242,155; 10,268,800.
About NantHealth, Inc.
NantHealth, a member of the NantWorks ecosystem of companies,
provides leading solutions across the continuum of care for
physicians, payors, patients, and biopharmaceutical organizations.
NantHealth enables the use of cutting-edge data and technology
toward the goals of empowering clinical decision support and
improving patient outcomes. NantHealth’s comprehensive product
portfolio combines the latest technology in payor/provider
platforms that exchange information in near-real time (NaviNet and
Eviti), connected care solutions that deliver medical device
interoperability (DCX device connectivity platform and VCX patient
vitals software) and molecular profiling services that include
comprehensive DNA & RNA tumor-normal whole genome profiling
with pharmacogenomics analysis (GPS Cancer®; laboratory developed
test) and tumor-normal in vitro diagnostic (Omics Core℠; In Vitro
Diagnostic) profiling to report somatic alterations in 468 genes
and sequencing of 19,396 protein-coding genes to determine overall
tumor mutation burden. For more information, please visit
Nanthealth.com or follow us on Twitter, Facebook and LinkedIn.
This news release contains certain statements of a
forward-looking nature relating to future events or future business
performance. Forward-looking statements can be identified by the
words “expects,” “anticipates,” “believes,” “intends,” “estimates,”
“plans,” “will,” “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. Risks and uncertainties include, but are not limited to: our
ability to successfully integrate a complex learning system to
address a wide range of healthcare issues; our ability to
successfully amass the requisite data to achieve maximum network
effects; appropriately allocating financial and human resources
across a broad array of product and service offerings; raising
additional capital as necessary to fund our operations; achieving
significant commercial market acceptance for our sequencing and
molecular analysis solutions; establish relationships with, key
thought leaders or payers’ key decision makers in order to
establish our sequencing and molecular analysis solutions as a
standard of care for patients with cancer; our ability to grow the
market for our systems infrastructure, and applications;
successfully enhancing our systems infrastructure and applications
to achieve market acceptance and keep pace with technological
developments; customer concentration; competition; security
breaches; bandwidth limitations; our ability to continue our
relationship with NantOmics; our ability to obtain regulatory
approvals; dependence upon senior management; the need to comply
with and meet applicable laws and regulations; unexpected adverse
events; clinical adoption and market acceptance of our sequencing
and molecular analysis solutions; and anticipated cost savings. We
undertake no obligation to update any forward-looking statement in
light of new information or future events, except as otherwise
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and uncertainties, most of which are difficult to predict and are
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materially from those implied by the forward-looking statements as
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For more information: Press@nanthealth.com
Jen Hodson Jen@nant.com 562-397-3639
Kelly Neagu Kneagu@nanthealth.com
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