Specializing in medical affairs and clinical development, MCDXI Medical Diagnostics, Inc., works with, invests in, and advises many small and more advanced biotech companies to develop and introduce novel diagnostic technologies to clinical markets, particularly prior to or immediately following commercial launch. This has included development of clinical trials and clinical trial strategy for clinical adoption and guidelines, reimbursement strategy, medical advisory boards, medical education programs, publication and publication strategy, professional meetings and advocacy strategy, and medical marketing strategy. Selected clients have included LifeData, Parker Isaacs Instruments [now FormaPath], Sinai Labs, PromisDX, Google, Advanced Clinical, Clinical Genomics, Exact Sciences, OmniPathology, bioTheranostics, mirOculus, Cynvenio Biosystems, BioNano Genomics, Integen LLC, Model Software, and Selfa Inc. Selected projects have included a ctDNA assay for colorectal cancer based on methylation-specific PCR (Colvera™), a stool DNA based test for colorectal cancer screening (Cologuard™), a gene-expression based RT-PCR assay for cancer of unknown origin diagnosis (CancerTYPE ID™), gene sequencing for germline and somatic mutations, advanced methods for capture and genomic evaluation of circulating tumor cells, novel techniques for whole genome/ chromosome structural evaluation, novel semiconductor based point of care technology and novel software applications related to pathology, clinical diagnostics and integrated patient management. For more information contact MikeDuganMD@gmail.com

FormaPath [formerly Parker Isaac] has developed the Adipress to help pathologists optimize lymph node recovery from pericolic fat to better evaluate (or more accurately stage) patients with colon cancer. The company is developing other products to improve pre-analytic processes to help patients undergoing biopsies for cancer and other applications, including the new nToto automated biopsy handler recently introduced at USCAP 2024 in Baltimore. Both of these platforms are intended to improve pathology gross room efficiency and accuracy to aid pathologists in delivering high quality care to their patients.FormaPath is expanding its use at major cancer centers across the US and working with partners to develop other novel tools in this space. If interested, please contact me or FormaPath directly: www.formapath.com

LifeData has developed a leading mobile app designed for collecting patient reported outcomes (PROs) over variable longitudinal time frames. This is a leading app for Experience Sampling Method (ESM) or Ecological Momentary Assessment (EMA) used in psychology and behavioral medicine studies such as smoking cessation, drug addiction, post-traumatic stress disorder, pediatric concussion syndrome, etc. The mobile app can be tailored to deliver scheduled questions and care information, and can collect patient and caregiver initiated questions. "Triggers” to alert physician or nursing providers and other caregivers can be based on patient responses. Dashboards to review clinical data collected to any time point can be designed for any particular clinical use, or for enhanced patient management, compliance and patient education efforts. It is an open, flexible, easy to program platform, that can be customized for any PRO study. https://www.lifedatacorp.com

At Biocept we developed a proprietary CSF based assay called CNSide to quantify and analyze both tumor cells and cell-free tumor DNA [ctDNA], a.k.a. liquid biopsies, in patients with metastatic carcinoma and melanoma. I led our clinical strategic development as CMO and oversaw our CAP accredited CLIA clinical laboratory as Medical Director. The product grew to be widely used by neuro-oncologists and other oncology specialists around the US, however the company ceased operations in 2023.https://biocept.com/cnside-assay/

Clinical Genomics was a privately held biotechnology company developing innovative products for colorectal cancer diagnosis and monitoring. With a broad intellectual property portfolio including more than 20 issued and pending patents, Clinical Genomics developed and validated Colvera™, a sensitive and specific blood test for colorectal cancer recurrence monitoring that launched in the U.S. in December 2016. Colvera™ was a PCR-based test measuring in plasma two epigenetically modified genes, hyper-methylated BCAT1 and IKZF1, found in circulating cell-free DNA derived from cancer (ctDNA). This product was the result of almost a decade of research, development and clinical validation studies, including testing in more than 4,000 volunteers. The company has since reorganized and Colvera is no longer commercially available.

Exact Sciences Corp. (NASDAQ:EXAS) is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the U.S. Multi-Society Task Force on Colorectal Cancer.I helped lead medical education and clinical development efforts related to Cologuard following receipt of FDA clearance and its commercial launch in late 2014, prior to the first USPSTF draft guidance related to this product in October 2015 which was initially unfavorable and led to unexpected layoffs in November. About six months later the final USPSTF guidance included Cologuard under a "recommended CRC screening test" list, leading to its rapid expansion.http://www.exactsciences.com/

Medical Director of Quest Diagnostics Nichols Institute in Valencia, CA and member of the Quest Esoteric Business Unit Senior Leadership Team. Nichols Institute and the EBU team operate Quest's most advanced esoteric laboratories performing a large portfolio of tests in oncology, genetics, endocrinology, immunology, infection disease, toxicology and therapeutic drug monitoring with extensive capability in mass spectrometry related methods. I was principally involved in quality assurance, client related activities and medical affairs activities for Quest, particularly related to oncology, women's health, infectious diseases and health policy and reimbursement related topics for diagnostic testing.

bioTheranostics is a cancer diagnostics company previously owned by bioMerieux, Inc., currently by Hologic Inc. I was principally responsible for laboratory management, strategic development, medical education and client support for pathologists and oncologists. Primary products include CancerTYPE ID, a 92 gene RT-PCR based gene-expression assay for metastatic cancers of unknown primary, PRECIS biomarker panels for lung cancer, colon cancer, breast cancer, gastric cancer, gastro-intestinal stromal tumors (GIST) and melanoma, and Breast Cancer Index for evaluating long term recurrence risk (up to 10 years) and predicting likelihood of extended endocrine therapy benefit.

Vice President and head of Medical and Scientific Affairs engaged in establishing medical value in product development, clinical trial design and clinical trial management for products developed and managed within five life cycle teams including genomics and oncology, women's health (HPV/CT/NG), microbiology, virology and blood screening. Supervised team of M.D.s and Ph.D.s involved in each of the life cycle teams and those managing clinical trial operations. Involved in executive and global international leadership meetings and medical education, sales and marketing related functions, particularly related to the cobas HPV test and the cobas BRAF test launch.

Supervised staff of pathologists specialized in consultative diagnostic services based in New York (Manhattan) and Los Angeles, arranged into four services with solid tumor and hematopathology experts and directors in each location, as well as Dr. Juan Rosai, Senior Diagnostic Consultant based in Milan Italy. Recruited and grew team from about 22 to 35 full and PT staff over four year period. Helped lead strategic development of oncology franchise and client education related to companion diagnostics and esoteric test development. Assisted sales and managed care teams in developing our referral client base of pathologists and oncologists and extensive managed care contracts with national and regional payers. Genzyme Corporation sold Genzyme Genetics including nine laboratory locations to Laboratory Corporation of America in December 2010. I helped LabCorp with executive level integration planning for merger of US Labs and Genzyme Genetics. The combined entity became known as Integrated Oncology and more recently as LabCorp Oncology.

Supervised staff of quality assurance managers and laboratory directors in areas of biochemistry, immunology, microbiology, molecular virology, molecular genetics, cytogenetics and pathology. Directed laboratory during move to new facility in Valencia CA and through several leadership transitions. Specialty Laboratories was founded by Dr. James B. Peter in 1975 and went public on NYSE in 2000. It was acquired by AmeriPath in September 2005 and AmeriPath was acquired by Quest Diagnostics in April 2007. Specialty's name changed to Quest Diagnostics Nichols Institute Valencia in January 2011. I rejoined Quest Diagnostics Nichols Institute as Medical Director of the Valencia facility from 2013 to 2015.

Director of Laboratories for UCLA's major satellite hospital in Santa Monica with full-time faculty appointment. Supervised staff of 3 FTE pathologists as well as rotating pathologists and residents. Responsible for general surgical pathology, hematopathology, clinical laboratories, multidisciplinary tumor board, teaching, department leadership and hospital medical staff leadership committees.

Based in Torrance, CA practicing surgical pathology, hematopathology and cytology; multiple hospital appointments in southern LA County and Adjunct Asst Prof. at Harbor UCLA Medical Center

Harper Hospital and Children's Hospital of Michigan are Wayne State University and Detroit Medical Center affiliated hospitals. Member of multidisciplinary clinical care and research teams in pancreatic cancer, lymphoma and pediatric oncology. Responsibilities in adult and childhood hematopathology and surgical pathology. Director of Laboratories for Children's Hospital of Michigan.

Clinical Pathology training with specialty experience in Bone Marrow and Lymph Node Hematopathology, Flow Cytometry, Hematology, Coagulation, Cytogenetics, Molecular Genetics, Transfusion Medicine, Microbiology, Clinical Chemistry, Surgical Pathology and Fine Needle Aspiration Cytology.

Studied pathology and cytogenetics of childhood tumors including acute leukemias, bone and soft tissue sarcomas and brain tumors.

Supervised residents in areas such as Surgical Pathology gross room, biopsy "hot seat", frozen section diagnosis, autopsy and unknown case conferences with Dr. Juan Rosai.