Chromosome Analysis is a technique where the chromosomes from cells are visualized under a microscope during metaphase, the stage during cell division when chromosomes are condensed, to analyze the total number and structure of the chromosomes. Staining with Giemsa dye results in a specific banding pattern of light and dark stripes, known as G-banding, and allows identification of each chromosome.
DNA Sequencing deciphers the precise order of the adenine, cytosine, guanine, and thymine nucleotides within a DNA sample. Next-Generation Sequencing (NGS) platforms are highly automated and deliver large scale DNA sequence data with high speed and accuracy.
FISH is a cytogenetic technique that uses a fluorescently labeled probe to detect the location or absence of a target DNA sequence directly on a fixed slide preparation of chromosomes.
Flow cytometry is a technique for counting, sorting, and analyzing thousands of microscopic particles per second by passing a suspension past an electronic detection apparatus. Flow cytometry can be used for cell counting, cell sorting, and biomarker detection, as well as measuring total DNA, newly synthesized DNA, and gene expression. This technique allows simultaneous multiparametric analysis of physical and/or chemical characteristics.
Immunohistochemistry is the detection of expression levels and distribution of antigens (e.g. proteins) in a cell or tissue section (usually frozen or paraffin embedded tissues) using antibodies bound to the target that can be visualized through staining.
ISH is a hybridization technique using a labeled complementary DNA or RNA strand as a probe to bind to a specific DNA or RNA sequence target to localize the target within a chromosome or tissue.
Nucleic acid microarray analysis combines robotics, chemistry, computer science, and biology to study thousands of genes simultaneously. Thousands of spotted samples, DNA, cDNA, or oligonucleotides, are known as probes (with known identity). Probes are immobilized on a solid support, such as a microscope glass slides, silicon chips, or nylon membranes. Nucleic acid microarrays allow analysis of gene expression and discovery, and mutation analysis of many thousands of genes in a single reaction quickly and efficiently.
PCR is a molecular biology technique where a DNA template sequence is exponentially amplified from a single copy by a thermal cycling process. Through repeated cycles of heating and cooling, the target DNA is replicated using a thermo stable DNA polymerase and DNA primers complementary to the target region.
Chief Executive Officer
Chief Commercial Officer
Global Director, IVD Operational Excellence
Chief Financial Officer
Quality Assurance Director
Chief Medical Officer
Vice President, General Counsel, Chief Compliance Officer and Privacy Officer
Kenneth J. Bloom, MD has been the Chief Medical Officer since 2005 and was the original Medical Director of Clarient Diagnostic Services. Dr.
Bloom’s career spans more than 30 years including key positions in start-up companies, University-based Medical Centers and commercial laboratories.
As an early adopter of information technology, Dr. Bloom developed the Pathology Information System at Rush Medical Center and helped design the
hospital’s Tumor Registry and Surgical Information System. Using this technology, Dr. Bloom co-founded Initiate Systems, which just prior to its sale
to IBM, was estimated to hold an 80% share of the software market that linked individual patient records across various healthcare databases. During
his residency, Dr. Bloom developed the first commercial Telepathology system and co-authored the key technical papers. He was an invited speaker at
the First International Conference on Clinical Application of Telemedicine in Tromso, Norway in 1993.
Dr. Bloom came to Clarient from Irvine, CA-based US Labs, where he served as Senior Medical Director since 2002. Dr. Bloom’s academic posts have
included Clinical Professor of Pathology at USC, Keck School of Medicine, Associate Professor of Pathology at Rush Medical College and one year as a
visiting Professor in the Department of Computer Science at DePaul University. Over the past 15 years, Dr. Bloom has held more than 10 appointed
positions at Chicago-based Rush Presbyterian-St. Luke’s Medical Center, one of the leading cancer research hospitals in the US. Those positions
included Director of Laboratory Operations, Director of Immunohistochemistry, Consultant to the Rush Breast Cancer Center, and Director of Information
Services for the Rush Cancer Institute.
Dr. Bloom has, for more than three decades, been a prolific researcher and lecturer in the fields of pathology, cancer, telemedicine and
informatics. He is a sought after speaker both nationally and internationally and has presented for the College of American Pathologists,
International Academy of Pathology, Royal College of Pathologists of Australasia, American Society of Oncology, American College of Surgeons, American
Society of Breast Surgeons and numerous state and local pathology societies. He has published over 50 peer-reviewed articles, more than 100 abstracts
and several book chapters. He has been a member of the College of American Pathologists since 1987 and has served on several committees including the
Diagnostic Immunology Resource Committee, the Immunohistochemistry Committee, the Technology Assessment Committee, the Personalized Healthcare
committee and as a member of the initial CAP/ASCO guideline committee for HER2 assessment. Dr. Bloom is a member of the House of Delegates for the
College of American Pathologists and is a Foundation Board Member of the US and Canadian Association of Pathology.
Dr. Bloom has served as principle investigator of more than a dozen clinical trials and has served as an advisor to numerous Pharmaceutical and
Bio-Technology Companies. He is President and CEO of Clarient Pathology Services.
Cynthia (Cindy) Collins, CEO Clarient, GE Healthcare, has over 30 years of experience in leading global teams in diagnostics, biotech, and pharmaceutical businesses and most recently served as President and CEO of GenVec, Inc., a publicly-traded biopharmaceutical company focused on developing gene therapies and vaccines. Ms. Collins previously served as Group Vice President, Cellular Analysis Business of Beckman Coulter until its sale to Danaher in 2011. Prior to joining Beckman Coulter, Ms. Collins served as President and CEO of Sequoia Pharmaceuticals, Inc., a private biotechnology company developing antiviral drugs for HIV and HCV. Before joining Sequoia Pharmaceuticals, Ms. Collins served as President of Clinical Micro Sensors, Inc., a wholly owned subsidiary of Motorola (now GenMark Diagnostics) where she directed the development and commercialization of molecular diagnostic microarray products and led the eventual strategic divestiture of the division. Before Motorola, she spent over 17 years at Baxter Healthcare in a variety of executive roles, including President of Global Oncology and Vice President of Strategy and Portfolio Management of the BioScience business. Prior to joining Baxter Healthcare, she worked six years in the Diagnostics Division of Abbott Laboratories in a series of operational assignments. Ms. Collins received her BS degree in Microbiology from the University of Illinois, Urbana and her MBA, with a specialization in marketing, from The University of Chicago Booth School of Business.
Ms. Collins is a strategic advisor to Phase Holographic Imaging, Lund, Sweden and XRpro, Cambridge, MA. She is board member of BioHealth Innovations, Inc. in Rockville, MD.
J. Alan Cotton joined Clarient in 2013 to lead commercial operations and most recently served as Zone Vice President at Siemens Diagnostics where
he directed the sales and technical operations and played a key role in the execution of a national Performance Culture initiative. Mr. Cotton
previously served as Vice President, Sales for Viracor-IBT. Prior to joining Viraco-IBT, Mr. Cotton held various roles at Beckman Coulter, Inc.,
including successful efforts for medical diagnostic sales of chemistry, hematology, immunoassay, automation and IT products in the South Central
United States and leading the flow cytometry team for diagnostic and research sales across the United States as National Sales Director. Mr. Cotton
received his BS degree in biology from Jacksonville State University and a Master’s degree in Business Administration from Keller Graduate School,
Renika Sehgal joined Clarient as Chief Financial Officer in October 2012. Prior to joining Clarient, Ms. Sehgal served as the Risk Finance Manager
for General Electric’s Power Generation Services business where she supported the global service contract portfolio. Ms. Sehgal first joined GE as a
member of the Financial Management Program at GE Plastics in 2005. From there she continued on to roles within the GE Corporate Audit Staff from 2007
until 2011, where she oversaw various global teams across U.S., Europe and Asia, driving rigor and improvements in financial & operational processes.
Ms. Sehgal received her Bachelors of Science degree from Babson College in Wellesley, Massachusetts.
Michael W. Brown joined Clarient as Vice President, General Counsel, Chief Compliance Officer and Privacy Officer in August of 2011. Previously,
Mr. Brown served as Global Compliance Counsel at Edwards Lifesciences where he implemented its global compliance program for healthcare and anti-
corruption, directed its healthcare professional contracting program and oversaw its physician transparency reporting program. Prior to joining
Edwards in 2008, Mr. Brown served as Vice President, Assistant General Counsel, Compliance/Privacy for InSight Health Services Corp. where, from 1999
until 2008, he assisted InSight with going private, developed and implemented InSight’s Compliance/HIPAA program, and oversaw multiple
acquisitions/integrations that doubled the size of the company. From 1997 until 1999, Mr. Brown was Associate Operations Counsel for Tenet
HealthSystems and was responsible for performing the legal work for six acute care hospitals in California. From 1990 to 1997, Mr. Brown served as
Corporate Counsel and Compliance Officer for Apria Healthcare and its predecessor, Homedco. While there, he assisted with the initial public
offering, the merger creating Apria and other multi-million dollar acquisitions, created/oversaw Apria’s national contracting program, and was lead
in-house counsel responsible for negotiating the settlement of the company’s qui tam action and oversaw the implementation of Apria’s corporate
Mr. Brown holds a JD from Pepperdine University, School of Law and graduated cum laude with a BA in Political Science from California State
University at Fullerton. He is admitted to practice law in California and is a frequent speaker on compliance, privacy, and other legal-healthcare
Mark Machulcz joined Clarient in 2011 to help with international and domestic expansion efforts of the diagnostic business. Prior to his role at Clarient, Mark served as Executive Vice President of Operations of PLUS Diagnostics, Inc. and oversaw its California and New Jersey laboratory operations and support staff. Mr. Machulcz previously directed pan-India operations for a unit of Quest Diagnostics Incorporated. Prior to that position, he served as a Director of Clinical and Anatomic Pathology Operations for a unit of Quest. During his tenure at Quest Diagnostics, he improved its anatomic pathology service levels and productivity, and implemented six sigma projects that contributed to more efficient lab operations. Mr. Machulcz received his Bachelor's degree in Medical Technology from St. Louis University and his Master's degree in Business Administration from Johns Hopkins University.
Ed Menezes, QA Director, joined Clarient in 2014 and has more than 15 years of quality assurance experience within the areas of biotech,
pharmaceutical manufacturing and clinical diagnostics including oncology and anatomic pathology. During his career Mr. Menezes served as the Regional
Quality Manager at Laboratory Corporation of America (formally Genzyme Genetics) for over 5 years and was responsible with overseeing several clinical
diagnostic laboratories located in Los Angeles, Phoenix and New York. Prior to that, Mr. Menezes worked for 3M Pharmaceuticals in a variety of QA
leadership roles including heading change management, validation and cGMP training programs. Mr. Menezes has also worked with Grifols Biologics
(formally Alpha Therapeutic Corporation) where he served in various QA roles including, Change Management, cGMP Training and Compliance. Mr. Menezes
received his BA degree in Organizational Communication from California State University Long Beach.
Jamie Brown, Global Director, IVD Operational Excellence, joins us from the Global Supply Chain Lean CoE
where he served as the Global Operational Excellence Master Black Belt & GSC Integration Lead for
Dharmacon. During his tenure, Jamie played key role in the execution of workflow optimization, change
management imperatives and simplifying Laboratory operations and supporting functions. In doing so, Jamie
partnered with Nina Green and the Operational Leadership team here at Clarient. Jamie has more than 20
years of experience in operations management and driving productivity initiatives in prior roles including
serving as the Head of Lean Six Sigma at Gatwick Airport and as the Global Lean Six Sigma Master Black Belt
at GlaxoSmithKline. Additionally, has held roles at GSK as a Production Manager and Site Leader.
Steve Hoyt, IT Leader, joined Clarient in 2015 and has more than 16 years of Information Technology experience in the Healthcare Industry. Prior to joining Clarient, Steve was the Global IT Integration Manager for GE Healthcare Life Sciences and Operations Manager for the Business Intelligence Center of Excellence at GE Healthcare. Steve joined GE as a member of the Information Technology Leadership Program (ITLP) with GE Healthcare in 1999 and progressed through assignments in Service and Supply Chain before becoming a certified Master Blackbelt in 2010 and a graduate of the Experienced Information Management Program (EIMP) in 2013.
Brian Montgomery, joined Clarient as General Manager in 2015. Prior to joining Clarient, Mr. Montgomery led the successful acquisition and integration of three biotechnology businesses purchased from Thermo Fisher Scientific by GE Healthcare, Life Sciences for $1.1B.
Mr. Montgomery first joined GE in 2002 on the Operations Management Leadership Program at GE Aviation, rotating through assignments in sourcing, Lean Six-Sigma and manufacturing. From there, he continued on to roles within the GE Corporate Audit Staff from 2005 until 2009, where he oversaw various global teams across U.S. and Europe focused on driving compliance and improvements in financial and operational processes at GE Capital and within the GE Industrial portfolio.
Mr. Montgomery joined GE Healthcare, Life Sciences in 2009, first serving as the Global Financial Planning & Analysis Leader. He then relocated to Uppsala, Sweden in 2012 to serve as Chief Financial Officer of its Bioprocess division, a leading provider of products, services and solutions to the biopharmaceutical manufacturing industry.
Mr. Montgomery received his Bachelors of Science degree in Industrial & Systems Engineering from Virginia Tech in Blacksburg, Virginia, and currently serves on the Board of Directors of its Alumni Association.