Agena Bioscience Expanding Ultrasensitive Rare Mutation Detection Technology

 Agena Bioscience Expanding Ultrasensitive Rare Mutation Detection Technology

PR Newswire

SAN DIEGO, May 30, 2014

SAN DIEGO, May 30, 2014 /PRNewswire/ --Agena Bioscience, Inc., which recently
acquired the Bioscience business of Sequenom, Inc., today announced expansion
of the UltraSEEK™ technology, the first ultrasensitive somatic mutation
detection technology for high-throughput and definitive interrogation of rare
mutations that occur at less than 1% abundance in matched tissue, circulating
plasma, and tumor samples. The first panel made available this year, the
UltraSEEK Oncogene Panel, uses 40 nanograms of input DNA to interrogate 26
driver mutations in 12 critical oncogenes. An online tool for designing custom
UltraSEEK panels for ultrasensitive interrogation of low-level mutations on
the MassARRAY® System will be available to the clinical research community
later this year.

Agena Bioscience is a San Diego, CA based life sciences and clinical
diagnostics company that offers the MassARRAY System. The system is a highly
sensitive, quantitative method for nucleic acid detection via MALDI-TOF mass
spectrometry for high-throughput genotyping and mutation profiling for cancer
and other disease research, companion diagnostics, pharmacogenomics,
epigenetics, clinical genetics, ag-bio, genetics, and biobanking molecular
sample identification.

Tumors harbor many cells with differing genetic mutations. While some of these
cells may contain mutations that confer resistance to targeted inhibitors,
they may compose such a miniscule component of the tumor that these cells are
not detected using  standard genotyping and sequencing methodologies. Those
methodologies have analytical sensitivity limited to mutations at 5–10%
abundance. Additionally, they restrict analysis to solid tumor samples and
force compromise between sample number and depth of coverage. In the rare case
low-level mutations were detected using newer methodologies such as digital
PCR, few if any studies have addressed the utility of these low-level
mutations in the context of therapeutic response.

The UltraSEEK technology enhances the sensitivity of the single-allele base
extension reaction (SABER) method for MassARRAY genotyping. The SABER method
was recently employed by Dr. Kazuto Nishio and colleagues at Kinki University
in Osaka, Japan and several Japanese medical centers to profile lung
cancer-related gene fusions and rare somatic hotspot mutations that may affect
patients' therapeutic responses in a phase III trial of multiple lung cancer
drugs. Data from the study will be presented at the American Society for
Clinical Oncology (ASCO) annual meeting in Chicago on Saturday, May 31.

"UltraSEEK puts us on the cusp of understanding how to treat chronic diseases.
For investigators interested in liquid biopsies to monitor therapeutic
response, the unsurpassed sensitivity and throughput that the UltraSEEK
technology affords allows acquisition of the biological data necessary to
address resistance to targeted inhibitors and/or minimal residual disease,"
said John Lillig, the Chairman and interim CEO of Agena Bioscience.

"Certain cancer therapeutics are extremely effective at shrinking specific
tumor types, such as treating non-small-cell lung cancer with anti-EGFR
inhibitors. Dr. Nishio's study indicates that detecting in blood plasma a
low-level mutation such as T790M, which occurs at a frequency sometimes below
0.5%, may indicate future tumor regrowth and the need to assess an alternative
treatment plan," said Lillig.

The UltraSEEK method employs a PCR reaction followed by an extension reaction.
The extension reaction utilizes a single mutation-specific chain terminator
labeled with a moiety for solid phase capture. After capture, wash, and
elution, products are spotted onto a research-use-only SpectroCHIP® Array for
MALDI-TOF analysis on any MassARRAY System. The method can be conducted on
96-well and 384-well plates, the smaller of which accommodates up to 24
samples to facilitate studies comparing multiple sample types.

The entire workflow for the UltraSEEK panels, from extracted sample DNA to the
final mutation report, can be completed in a single day.

The UltraSEEK Oncogene Panel and MassARRAY System are For Research Use Only.
Not for use in diagnostic procedures.

About Agena Bioscience
Agena Bioscience is a San Diego, CA based life sciences and clinical
diagnostics company that recently acquired the Bioscience business of
Sequenom, Inc. and is now offering the MassARRAY® System. The system is a
highly sensitive, quantitative method for nucleic acid detection via MALDI-TOF
mass spectrometry for high-throughput genotyping and mutation profiling for
cancer and other disease research, companion diagnostics, pharmacogenomics,
epigenetics, clinical genetics, ag-bio genetics, and biobanking molecular
sample identification.
www.agenabioscience.com 

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SOURCE Agena Bioscience

Website: http://agenabioscience.com
Contact: Ryan Ferrell, Desk/Mobile: 312.506.5202, ryan.ferrell@hdmz.com
 
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