NATICK,
Mass., July 30, 2024 /PRNewswire/ -- Pillar
Biosciences, Inc., the leader in Decision Medicine™, has announced
that Molecular Pathology Laboratory Network, Inc., (MPLN) is now
the first national molecular reference laboratory to verify and
launch oncoReveal™ CDx.
The oncoReveal™ CDx pan-cancer solid tumor IVD
kit has been FDA PMA approved for general tumor profiling for 22
clinically relevant genes across all solid tumors, including CDx
claims for KRAS (Erbitux® & Vectibix®) in colorectal cancer
(CRC) and EGFR (TKI Class Approval) in non-small cell lung cancer
(NSCLC). oncoReveal™ CDx has a rapid single-day
workflow that can be performed by any clinical laboratory enabled
with an Illumina MiSeq™ Dx platform with an
integrated sample-to-report time of as little as 48 hours. Up to 46
clinical samples can be performed on a single MiSeq™ Dx
run.
"We are proud to partner with Pillar Biosciences on the global
launch this important IVD assay kit," said Dr. Roger Hubbard, Ph.D., Chief Executive Officer,
Molecular Pathology Laboratory Network. "MPLN's goal is to bring
innovative technologies to diagnostic care and clinical trial
studies. We see this diagnostic assay as an important clinical tool
to help quickly select certain cancer patients for 1st
line targeted therapy or clinical trials. Given this assay was an
FDA approved kit, our laboratory team was quickly able to perform
full IVD assay verification within 2 weeks of training. We look
forward to working with our physician network and biopharma
partners to implement this new solid tumor IVD product."
"The potential of increased FDA regulation on LDTs is putting
immense pressure on CLIA-certified molecular reference
laboratories," said Dan Harma, Chief
Commercial Officer, Pillar Biosciences. "The launch of our
oncoReveal™ CDx now enables these laboratories with
an FDA approved solid tumor assay which can be quickly and easily
verified and performed in any laboratory with an Illumina
MiSeq™ Dx NGS platform to rapidly profile patients
with solid tumors. We see this as a great opportunity to improve
care and reduce the delay in patients receiving targeted
therapy."
About Pillar Biosciences
Pillar Biosciences is the leader in Decision Medicine™, which is
the utilization of highly accurate and sensitive next-generation
sequencing (NGS) testing technology to generate data that optimizes
selection of precision therapies for cancer patients, from tumor
profiling to therapy selection, and recurrence monitoring. Pillar's
NGS testing solutions are powered by its proprietary SLIMamp® and
PiVAT® technologies, helping to localize the testing process,
reduce diagnostic costs and improve access and efficiency of
complex NGS testing for clinicians, prescribers, and patients
globally. The company has more than 20 NGS testing kits available
in IVD or RUO formats, with multiple panels in various stages of
development. Pillar Biosciences has operations in Natick, MA. For more information visit
pillarbiosci.com and connect with us on LinkedIn.
About MPLN
Molecular Pathology Laboratory Network (MPLN) has been at the
forefront of laboratory medicine since its inception in 1989 and
inspired the genesis of women's health testing using molecular
diagnostics and technology. For decades, MPLN has continued to lead
the way in specialty testing with an emphasis on women's health and
oncology. MPLN strives to be the best client experience in
laboratory medicine by bringing you comprehensive specialty
testing, informatics using the latest digital applications, and
unparalleled customer service. Our history is rich and rooted in
our foundation of providing the very best in patient care, by
exploring, developing, and delivering innovative solutions and
technologies that elevate our field. Providing an expanding menu of
molecular diagnostics, specialty anatomic pathology, flow
cytometry, fluorescence in situ hybridization and cytogenetic
testing, MPLN is dedicated to providing superior diagnostic
services to our clients in pathology groups, hospitals, medical
laboratories and physician groups nationwide. MPLN has operations
in Maryville, TN. For more
information visit mpln.net and connect with us on LinkedIn.
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SOURCE Pillar Biosciences, Inc.