The story is being written,
which is why the time to talk is now.
Acutis Biosciences, a member of the Acutis Family of companies, is a provider of biomarker-based analysis,
as well as expert assay development and robust data analytics.
We are a company with the means and expertise to partner with forward-looking life sciences-related businesses, including pharmaceutical companies, contract research organizations (CROs),
diagnostics manufacturers and others.
Licensed by the State of New York’s Department of Health,
Acutis Diagnostics has undergone the most rigorous inspection and vetting processes.
As a result, we can reliably meet your biomarker needs and provide outcomes you can employ with confidence.
With our expanding menu of both FDA-cleared as well as New York State LDTs, Acutis Biosciences offers
the expertise that comes from analyzing more than 500,000 patient samples and tens of millions of data points.
We have built a company you can trust. A company long recognized for offering highly accurate results,
in best-in-class turnaround times. In addition, we’re company focused on innovation, with new technologies
under development, all intended to drive discovery.
Privately held and self-financed, we are committed to serving the needs of Life Sciences companies.
Our unique positioning enables Acutis Biosciences to quickly scale up our internal resources
or expand resources as needed.
What’s more, and of growing importance, our relationships with advanced diagnostics providers enable our company to access the latest in bio analytical platforms, thus assuring access to an abundance of actionable data.
Information we can share with our partners, to advance our science and technology, while fast-tracking
the development process, and, ultimately, accelerating FDA approval.
let's go to work.
Clinical Evaluation of a Robust Custom-Designed Multiplexed qPCR Microarray
for Urinary Tract Infections.
Nov.7-9, 2019 - Baltimore, MD, USA
Acutis Biosciences, division of Acutis Diagnostics, announced today that its scientific presentation and publication, “Clinical Evaluation of a Robust Custom-Designed Multiplexed qPCR Microarray for Urinary Tract Infections” is the subject of both a poster presentation at the upcoming Association for Molecular Pathology meeting, as well as an abstract in the November 2019 issue of The Journal of Molecular Diagnostics. Acutis scientists validated 30 individual molecular assays covering the most common causative agents of urinary tract infections, including both bacteria and fungi, achieving 100% specificity and over 96% sensitivity with 96% accuracy when compared with culture. The rigorous validation process that was used by Acutis is the subject of the presentation.
“We are very excited to announce the details of our first infectious disease developmental project and are honored to be selected to present our research at AMP,” said David Goldberg, Managing Director of Acutis Biosciences. UTIs are some of the most common bacterial infections, affecting some 150 million individuals globally. Thus, there is a need for a robust, economic and rapid assay that can pass a rigorous analytical and clinical validation process.
This publication demonstrates the expertise in biomarker and assay development assembled at Acutis Biosciences. “We look forward to expanding our reach with diagnostic and pharmaceutical partners, as well as to the commercial roll out of this assay in 2020,” he continued.
Added Dr. Mayil Shanmugam, Director of Research and Development at Acutis Biosciences and Lead Author of the publication, “Our assay is one of the first multiplexed PCR products to undergo the level of rigor that we have utilized during the development process. After working out the design parameters of the array, we then analyzed each individual assay against actual intact organisms for sensitivity, specificity, linearity, interference and stability as well as running check boarding titration experiments. Our theoretical limit of detection calculation was shown to match the actual assay performance for each and every organism we evaluated, thus demonstrating a robust assay design. We also developed a standardized nucleic acid extraction process which we can utilize across a wide range of other applications.” The work performed by Acutis Biosciences also furthers protocols and validation standards for other ongoing research work at the laboratory.
As a member of the Acutis Family of companies, Acutis Biosciences is the provider of biomarker-based analysis, as well as expert assay development and robust data analytics. Acutis Biosciences leverages the clinical expertise of Acutis Diagnostics and its work in analyzing more than 500,000 patient samples and tens of millions of data points. Our team of scientists have established laboratory developed tests across molecular, microbiology and metabolomic platforms.
David C. Goldberg
Mr. Goldberg is an accomplished industry professional, having spent more than 35 years in leadership roles in the life sciences and healthcare industry. He had a long career at Enzo Biochem Inc, where he served as President and General Manager of the company’s clinical services and research products divisions, as well as serving as both the Vice President of Business Development and Corporate Development for the parent company. Goldberg also served as Chief Operating Officer at Aeon Global Health, where he oversaw worldwide operations for the publicly traded healthcare organization.
His areas of responsibility have included: strategic planning, marketing and sales, technology assessment, P & L, and compliance. He has presented at numerous investor-and partnering-conferences. Goldberg received an MS in Microbiology from Rutgers University and an MBA in Finance from New York University.
PhD, Director of Research and Development
Dr. Shanmugam is a research scientist in the areas of molecular biology and infectious diseases. He has authored nearly 25 peer-reviewed papers, in such areas as the use of biofilms in the treatment of wounds and the study of protein expression during atrial fibrillation. His research led to the first complete sequence of a key strain of Aggregatibacter actinomycetemcomitans, an important periodontal pathogen.
He served most recently as a research associate in the departments of Oral Biology and Cell Biology, as well as Molecular Medicine at the University of Medicine and Dentistry of New Jersey. A recipient of a Howard Hughes Medical Institute fellowship, Dr. Shanmugam earned his PhD in Genetics and Molecular Biology at Madurai Kamaraj University and completed post-doctoral fellowships at both the Weizmann Institute and Cold Spring Harbor Laboratories.
Ted E. Schutzbank
PhD, D (ABMM), Director of Clinical Microbiology and Genetics
Dr. Schutzbank is an expert in both clinical bacteriology, virology and medical genetics. He has held faculty positions at the University of Cincinnati, George Washington University, and New York Medical College. Dr. Schutzbank has authored nearly 30 peer-reviewed articles, 10 book chapters and has co-authored Clinical Laboratory Standards Institute (CLSI) guidelines in molecular diagnostics techniques and quality easement.
He has also served on a number of corporate scientific boards for such companies as Qiagen, Luminex and IGEN International (now Roche), and has presented both nationally and internationally on such topics as nucleic acid-based technology evaluation, population health, and personalized medicine. Dr. Schutzbank received his PhD from Columbia University and completed a post-doctoral fellowship at the State University of New York at Stony Brook.
DABCC, FAACCC, Director of Biomarker Development and Precision Medicine
Dr. Halim is an internationally recognized thought leader in both biomarker development and pharmacogenomics. He has served as the Vice President of Translation Medicine at Celldex Therapeutics and the Global Head of Biomarker Development for Daiichi Sankyo in Japan. He is one of a select few triple-board certified clinical laboratory professionals in the areas of Molecular Diagnostics, Clinical Chemistry and Toxicology, and has extensive expertise in GCP, GLP, FDA and CAP guidelines and regulations.
Dr. Halim has authored more than 60 peer-reviewed articles on such topics as companion diagnostic development, population pharmacokinetics/pharmacodynamics and the impacts of discordant clinical laboratory results on the drug development process. His book, Biomarkers, Diagnostics and Precision Medicine in the Drug Industry, was published by Elsevier in 2019.
Dr. Halim received his Doctorates in Pharmacology from Bonn University, and a PhD in Biochemistry for the University of Cairo and completed a post-doctoral fellowship at the University of Tennessee.
Dr. Maddali is a global business leader in the field of precision medicine. She most recently served as the Vice President of Strategy and Business Development for Cancer Genetics, Inc. Maddali had previously held senior management positions with Q2 Solutions, where she was the Global Head of Devices and Business Strategy. She has also served as Associate Director of Biomarkers and Companion Diagnostics at Quintiles IMS.
Dr. Maddali has completed more than 170 biopharma/CRO/IVD commercial partnerships over the past 10 years and has presented on such topics as CAR-T as well as the use of blockchain in precision medicine. She earned her PhD in Physiology and Pharmacology at the University of Missouri and a Doctor of Veterinary Medicine from Sri Venkateswara University in India.