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History
Experience MPLN
Celebrating more than 30 years
2023
Launch of Global Laboratory Network for Clinical Trials Support...
Following the rapid expansion and growth of MPLN’s Biopharma Geneuity® Clinical Research Services business, partnerships with ISO15189/CLIA/CAP accredited labs in Europe and Singapore were established. These labs extend our clinical trial services to EMEA and APAC regions and establish MPLN as a truly global specialist molecular pathology laboratory provider.
2022
MPLN Supports Large, Global CLL Clinical Trial
MPLN Geneuity™ Clinical Research Services launches partnership with large pharmaceutical company to support a Phase III global clinical trial targeting CLL. Testing involved a multi-modal approach using sequencing of the immunoglobulin variable region gene (IgVH), fluorescent in situ hybridization (FISH), and complex karyotyping. Global logistics were optimized to achieve testing within validated stability windows.
2021
Key Opinion Leader (KOL) pathology network launched
MPLN-Biopharma Services forms partnerships with leading US Expert Pathology groups to provide extended therapeutic expertise for its clients. Specialties include Gastrointestinal, Cytology, NASH, Liver, Solid Tumor (Head and Neck, Breast, NSCLC), and dermatopathology. All pathologists are connected to the MPLN Digital Pathology Network.
2020
Expansion of MPLN Biopharma Services
MPLN Geneuity™ Clinical Research Services division expands its global biopharma support with the formation of an experienced commercial and contracts team, dedicated project services group, and scientific data specialists. These teams provide the framework and platform required for future clinical trial business growth while also offering seamless project and data management services to MPLN’s rapidly expanding biopharma, CRO, and IVD client base.
2019
MPLN Validates new NGS Myeloid panel
Detect single nucleotide variants, insertions, deletions, copy number variations, and internal tandem duplications with targeted NGS of 75 genes relevant for acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), myelodysplastic syndromes (MDS), and lymphoid malignancies research.
2018
MPLN supports IVD Study for New Colorectal Cancer Screening Assay
MPLN’s Geneuity™ Clinical Research scientists optimized a colorectal cancer screening assay protocol and tested 12,000 stool samples. Results from the client’s new qRT-PCR assay were cross-compared to two ELISA-based methods. Final results were submitted to the FDA for approval of the new colorectal cancer screening assay.
2017
MPLN becomes approved collaborator with Kolon Life Sciences
Developed assays and studies for the world's first cell & gene therapy for osteoarthritis, TG-C
2016
LIS Blue verion 7.0
Released 4th Generation web-enabled LIS; Permitting global access
2015
ISO15189 accreditation
ISO15189 accreditation obtained making MPLN 7th laboratory in USA to obtain this global distinction; Implemented NGS platforms illumina® MiSeqDx® and Thermo Fisher® PGM® Ion Torrent. Launched NGS assays for Cystic Fibrosis 139, CFTR gene and Solid Tumor NGS Panels. Invested in digital PCR.
2014
Genomic Solutions Division and Next Generation Sequencing
Genomic Solutions Division and Next Generation Sequencing technology launched; purchased 1st first FDA approved illumina MiSeqDX system sold in the US; Invested in 10 color flow cytometry with purchase of Beckman Coulter Navios® flow cytometry systems. Implemented Partners Program with first two large, integrated oncology practices.
2013
Pathology Partnerships Program
Pathology Partnerships Program implementation; Purchased Gen-Probe's PANTHER® System to expand testing for STD's Trichomonas Vaginalis and enable random access loading
2012
IT Infrastructure
MPLN began building the IT infrastructure and colocation facility to support our Next-Generation Sequencing efforts. Modern and mobile-friendly websites were developed for both MPLN and Geneuity, as well as Indigo, the iOS app component of our LIS.
2011
Validated Trichomonas Vaginalis by TMA...
Validated Trichomonas Vaginalis by TMA on Gen-Probe's Tigris® system. Performed 510K data collection for Gen-Probe Panther®
2010
Expanded test menu...
The New Year provides MPLN with ample opportunities to expand its test menu. So far the laboratory has validated several new markers by IHC and CISH, including the DOG1 marker for GIST.
2009
Celebrating 20 years of success...
MPLN, with five laboratories and approximately 130 employees, celebrated its 20th anniversary July 1, 2009. In an effort to make a difference in healthcare for another 20 years, MPLN added the KRAS mutation test and BRAF analysis to the oncology test menu. These tests assist with identifying colorectal cancer patients most likely to show limited clinical response to anti-epidermal growth factor receptor therapies.
2008
MPLN expanded its anatomic pathology...
MPLN expanded its anatomic pathology laboratory and opened a second Ascendant Medical Laboratory in Memphis to serve the West Tennessee medical community. 2008 was another award winning year. MPLN was presented with the Pinnacle Innovator Award by the Knoxville Chamber of Commerce and a marketing award from the Diagnostic Marketing Association. A grassroots effort led by MPLN resulted in proclamations in eight states that recognized May 19 as Phelan-McDermid Syndrome Day and the last week in July as Phelan-McDermid Syndrome Week.
2007
Clinical Research Services
MPLN expanded its clinical research division to form a dedicated clinical trials company, Geneuity™ Clinical Research Services. MPLN also developed an ABL gene mutation test to detect Gleevec® resistance in CML and implemented the JAK2 V617F quantitative assay for chronic myeloproliferative disease. MPLN won a Business Excellence Award from the Knoxville Chamber and two marketing awards from the Diagnostic Marketing Association. MPLN also developed Symphony™, an information exchange system that provides seamless connectivity to clients.
2006
Named the anchor tenant...
MPLN was named the anchor tenant for a future 450-acre R & D Park in Blount County. To meet MPLN’s expected growth over the next three to five years, the new laboratory is expected to be approximately 65-75,000 square feet. MPLN reached 100 employees in 2006, installed Luminex™ technology platform and opened immunohistochemistry laboratory. MPLN was also one of the first regional reference laboratories in the Southeast to offer the CellSearch™ Circulating Tumor Cell, now used as an aid in monitoring metastatic breast, colorectal and prostate cancers.
2005
Opened a clinical reference laboratory...
MPLN opened a clinical reference laboratory, Ascendant Medical Laboratory, in Knoxville, TN., offering routine and specialty testing to clinicians throughout East Tennessee. Ascendant complements MPLN’s offerings and provides a single source for reference laboratory testing. MPLN's Research and Development division participated in its first clinical trial. MPLN also validated CT/NG testing on SurePath™ liquid cytology and was one of the first laboratories in the country to offer CT/NG and HPV testing on both SurePath and ThinPrep® liquid cytology media.
2004
Named a Molecular Center of Excellence...
In early 2004, Roche Diagnostics Corporation designated MPLN as a member of the Molecular Centers of Excellence Alliance. A few months later, MPLN celebrated its 15th anniversary, and opened a cytogenetics laboratory. That same year, MPLN developed quantitative PCR for minimal residual disease detection for chronic myelogenous leukemia and acute promyelocytic leukemia.
2003
MPLN implemented gene rearrangements...
In 2003, MPLN implemented gene rearrangements by PCR, a very fast technique that assesses clonality in lymphoproliferative disorders. Because PCR is extremely sensitive and requires small quantities of DNA, it has been applied to small biopsies and fixed paraffin-embedded tissues.
2002
MPLN expanded its services...
In April 2002, MPLN expanded services by opening a satellite flow cytometry laboratory in Richmond, Va. and a dedicated research and development laboratory in Maryville. The laboratory also implemented UroVysion™ Bladder Cancer screen by FISH, validated HCII HPV assay on SurePath™ liquid cytology, and earned a New York license that year.
2001
MPLN opens new lab...
MPLN opened the doors to a new 27,000-square-foot facility in 2001 in downtown Maryville, where the network's headquarters remain today.
2000
Collaborated with Gen-Probe...
In 2000, MPLN collaborated with Gen-Probe on BCR/ABL by TMA to determine BCR/ABL transcript levels in patients with chronic myeloid leukemia. The laboratory also validated Chlamydia trachomatis and Neisseria gonorrhoeae testing on ThinPrep® media, becoming one of the first laboratories in the country to offer CT/NG and HPV testing on a single specimen.
1999
MPLN implemented HER2/neu by FISH...
In 1999, MPLN implemented HER2/neu by FISH, which is used as an adjunct to existing clinical and pathologic information when analyzing prognostic factors in stage II, node-positive breast cancer patients. The laboratory also validated HIV sequence-based mutation analysis and the Hybrid Capture II® assay for human papillomavirus.
1998
A new generation of diagnostic testing...
In June 1998, the complete genome sequence of Mycobacterium tuberculosis was published. The complete sequence of the approximately 4,400,000-base-pair Mycobacterium tuberculosis genome offered the foundation for a new generation of diagnostic testing.
1997
Implemented HER2/neu...
MPLN validated HER2/neu by Oncor, Inc., the first gene-based test for predicting whether a cancer will recur.
1996
The test menu continues to grow...
The test menu MPLN offers continues to grow with a focus on infectious diseases and women’s health, growing at a rate of more than 30 percent.
1995
Obtained license for PCR...
MPLN earned a license from Roche Molecular Systems to perform diagnostic testing using polymerase chain reaction ( PCR ), a Nobel-prize winning technology used to amplify, or copy on a large scale, specific DNA sequences.
1994
Validated Gen-Probe® M. Tuberculosis...
In 1994, MPLN validated Gen-Probe® Mycobacterium tuberculosis by transcription-mediated amplification, a process for increasing the number of target nucleic acid sequences to allow detection of a single nucleic acid molecule.
1993
Developed and validated a quantitative...
MPLN developed and validated a quantitative viral load assay for hepatitis C virus using polymerase chain reaction to reveal the presence of the virus in the blood and confirm an ongoing HCV infection.
1992
Dr. Hubbard was one of the first...
In 1992, Dr. Roger Hubbard, founder, president and CEO of MPLN, graduated from the FBI Forensic DNA Analysis program. He was one of the first laboratory directors to graduate from the program.
1991
Implemented flow cytometry for ploidy...
MPLN implemented flow cytometry for ploidy and leukemia/lymphoma analysis in 1991. With a turnaround time of one day, flow cytometry is highly specific and sensitive for the evaluation of leukemia, lymphoma and other hematological abnormalities.
1990
Implemented gene rearrangements...
In 1990, MPLN implemented gene rearrangements by Southern blot hybridization analysis, which was proven to be a helpful tool to establish clonality in T cell leukemias and lymphomas at that time.
1989
Dr. Roger Hubbard founded MPLN
In 1989, Dr. Roger Hubbard founded MPLN in a 400-square-foot laboratory in Blount Memorial Hospital in Maryville, Tenn. During that first year, MPLN earned CAP accreditation, validated the HPV in situ hybridization assay and was one of the first laboratories in the country to offer testing for human papillomavirus (HPV).
