DCN Diagnostics | Top In-Vitro Diagnostic Technology Solution Company 2018

MedTech Outlook Magazine

DCN Diagnostics
Pioneers of Next-Gen Lateral Flow Assays

CIO VendorBrendan O’Farrell, Co-founder & President
The in vitro diagnostics (IVD) market is evolving and growing at an accelerated rate. Factors that contribute to the ongoing progress of the market include the proliferation of point-of-care testing, growing demand for early disease diagnosis and increased demand for health and wellness monitoring by consumers. With more than 13 years in the IVD landscape, DCN Diagnostics leverages its vast experience in development of user-centric, high-performance rapid assays for clients across multiple industries. DCN has successfully developed well over 100 products including assays and their ancillary components like sample-handling devices, cassette systems, and integrated reader systems.

DCN Diagnostics’co-founder and president Dr Brendan O’Farrell knows that DCN’s expertise in advanced assay systems can meet any need that requires a sensitive and robust test without utilizing a laboratory. His company has developed tests for a multitude of market segments ranging from biomedical, veterinary, and agricultural diagnostics to bio-processing, industrial, food safety, consumer, bio-defense and radiological defense applications. “Our proficiency lies in designing and developing qualitative, quantitative, visual, reader-based, single-, and multi-plex assays for a plethora of analytes, matrices, and market segments,” he says. “Each product is unique, but they’re all designed with the end-user in mind to minimize errors and provide data quickly. More than that, though, we know that as a service company first and foremost, communication and a focus on customer experience are the keys to our success”.

“The types of products we develop run the gamut of complexity. On the one hand, we have developed very high sensitivity assays for infectious diseases, such as for malaria eradication, that require ultra-high sensitivity but have to be interpreted by eye—with no electronic readers—and used by minimally trained operators in low resource settings,” explains O’Farrell. On the other end of the spectrum, the company has developed highly complex systems such as a test for bio-dosimetry that takes a single drop of fingerstick blood, generates plasma without any equipment and measures the up- and down-regulation of four proteins quantitatively, yielding a digital readout that indicates the level of radiation exposure in an individual. “All of this in a device that is still simple and intuitive to use. The key to being able to develop at both ends of this spectrum is a deep understanding of the requirements of the user as well as the technical requirements for the test. This focus on the end user of the product allows us to develop for the consumer space as easily as for the professional medical market.”
DCN Dx is ISO 9001:2015 and EN 13485:2016 certified. It places a premium on transparency, particularly in its high-quality processes and its reporting procedures. These are “major elements of our clients’ trust in us” according to O’Farrell. DCN’s product development process begins with a product requirement and definition phase, proceeding to the feasibility and prototyping stage, and eventually to optimization, development, verification, manufacturing, transfer, and validation. DCN performs weekly technical reporting meetings with clients with web access and live data presentation to discuss progress. The client can also view updates on project goals and budgets via an online dashboard.

DCN operates as a fee-for-service organization; clients own any intellectual property developed for them at the end of development. “We don’t lock anybody out of their own product, build in any proprietary IP without our clients’ knowledge, or tie them to longer-term services in order to access our development capability,” says O’Farrell. “It’s not necessary for our clients to utilize our reagents or to use us for manufacturing.The client has complete freedom to decide if the product will be manufactured at DCN, by a contract manufacturer or at their own facility. Allowing the client to make key decisions about their own product seems logical to us, but unfortunately that’s not always the case in our industry.”

Our proficiency lies in designing and developing qualitative, quantitative, visual, readerbased, single-plex, and multiplex assays for a plethora of analytes, matrices, and market segments. Our success relies on providing clients with uniquely high-quality customer service

A unique differentiator for the company is the formalized education and training process that it provides to organizations across the IVD landscape. “We’ve trained over 150 organizations on not only the technical aspects of developing and manufacturing lateral flow assays but also on regulation, reimbursement, clinical trials management, and manufacturing,” says O’Farrell.

For the last five years, DCN has hosted the Advanced Lateral Flow Course, where hundreds of product developers, suppliers, manufacturers, intellectual property experts, and VCs engage in knowledge-sharing and networking. As a part of the event, DCN has introduced the Technology Innovation Award, a $10,000 competitive cash prize, to assist the IVD market in keeping pace with the growing needs.

Moving ahead, DCN Diagnostics aims to focus on continual evolution in the lateral flow technology. “We’re helping to bring this technology to new point of care market spaces such as molecular diagnostics,” says O’Farrell. DCN will also continue to expand its contract manufacturing capabilities and, as always, focus on improving the customer experience throughout its service and product offering.

Top 10 In-Vitro Diagnostic Technology Solution Companies - 2018

Company
DCN Diagnostics

Management
Brendan O’Farrell, Co-founder & President

Description
Focuses on contract development and manufacturing of user-centric, high-performance lateral flow rapid assays for diverse industries

DCN Diagnostics News

DCN Dx and Mapp Biopharmaceutical Announce Subcontract

Addressing the Need for the Rapid Non-subjective, Digitized Detection of Ebola and Ebola Family Viruses
CARLSBAD, Calif. - DCN Dx, announced a subcontract with Mapp Biopharmaceutical, Inc., a developer of novel pharmaceuticals for the prevention and treatment of infectious diseases, focusing on unmet needs in global health and biodefense.
The subcontract covers the development, optimization, and deployment of a digitized lateral flow assay to detect circulating Sudan ebolavirus (SUDV) antigen for real-time use in nonclinical studies taking place within biosafety level 4 (BSL4/ABSL4) containment laboratories.
"DCN Dx is proud to partner with Mapp Biopharmaceutical to develop medical countermeasures for SUDV," said Mitzi Rettinger, DCN Dx's Chief Revenue Officer. "This digitized lateral flow assay will be among the first to offer rapid, cage-side detection of SUDV antigens in nonclinical studies."
The Administration for Strategic Preparedness and Response (ASPR) recently announced a $109.8 million contract with Mapp Biopharmaceutical Inc., for the advanced development and potential purchase of a monoclonal antibody therapeutic to treat patients infected with SUDV.
There are currently no FDA-approved medical countermeasures available for the treatment of disease caused by SUDV. In addition, there is no assay available for the rapid detection of SUDV antigen in serum which provides a non-subjective, digitized result.
Assays using polymerase chain reaction (PCR) require labor-intensive methodology and inactivation of samples to perform the assay outside of BSL4 laboratories. Cartridge-based methods also require valuable bench space within the BSL4 and still involve an approximate wait time of 90 minutes for a result. The rapid diagnostic test (RDT) being developed by DCN Dx will address these challenges and improve the ability of BSL4 laboratories to carry out pivotal studies for the development of medical countermeasures against SUDV.

DCN Dx & BIOASTER Announce Collaboration for Development of Multiplex Rapid Diagnostic for Neglected Tropical Diseases

Grant from the Bill & Melinda Gates Foundation to develop rapid test for Onchocerciasis
CARLSBAD, CALIFORNIA - DCN Dx, a global leader in the end-to-end development, manufacturing, and commercialization of point-of-use tests, and BIOASTER, the French Technology Research Institute focusing on microbiology and infectious diseases, announced a collaboration as part of a second grant to BIOASTER for onchocerciasis diagnosis from the Bill & Melinda Gates Foundation.
Onchocerciasis, commonly referred to as river blindness, ranks as the second most prevalent cause of infectious blindness on a global scale. According to the World Health Organization (WHO) estimates, approximately 25 million individuals worldwide are currently infected, with an additional 90 million individuals at risk of contracting the disease. Notably, over 99% of these cases are concentrated in Africa, resulting in vision impairment for approximately 1.15 million individuals.
This initiative builds upon an initial grant awarded to BIOASTER in 2019. The primary objective is to enhance the specificity of the Ov16-rapid test, particularly with regard to its response to Loa loa and Mansonella perstans helminths, aiming to achieve a specificity level of 99.8% in accordance with the recommendations set forth by the WHO Diagnostic Technical Advisory Group (DTAG). The successful development of this test would significantly contribute to the eradication of onchocerciasis and the assessment of preventive chemotherapy programs.
In collaboration with the Laboratory of Parasitic Disease (NIAID) and DCN Dx, BIOASTER is committed to creating an advanced multiplex lateral flow assay designed to detect Onchocerca volvulus antibodies in human blood samples. This innovative diagnostic tool will incorporate a combination of novel and complementary O. volvulus antigens, with the careful selection and evaluation of these antigens being carried out at BIOASTER.
The diagnostic accuracy of this test will undergo rigorous evaluation using specimens from onchocerciasis cases and other parasitic helminths collected in the field. This evaluation will be conducted under the supervision of Professor Joseph KAMGNO at the Higher Institute of Scientific and Medical Research in Yaoundé (ISM), Cameroon (www.ismcm.org).
Xavier Morge (CEO, BIOASTER) noted, “We are proud that the Bill & Melinda Gates Foundation has continued its support as we aim to improve onchocerciasis diagnosis in the coming years.”
“This new grant from the Bill & Melinda Gates Foundation is a great example of BIOASTER's commitment to accelerate the development of a lateral flow test with high specificity for the diagnosis of onchocerciasis,” said Cyril GUYARD (CSO, BIOASTER).
Patrick Vaughan (COO, DCN Dx) expressed enthusiasm about the collaboration, stating, “We are delighted to partner with BIOASTER's scientific team to transform their key O. volvulus antigen research into a user-friendly and highly specific lateral flow test to advance onchocerciasis diagnosis.”
“DCN Dx’s core purpose extends beyond the technicalities of diagnostics," Mitzi Rettinger (Chief Revenue Officer, DCN Dx) explained. "We're striving to make a real difference in global health, and our partnership with BIOASTER on this vital project exemplifies that mission. By accelerating the development of a cutting-edge multiplex rapid test for African river blindness, we're making a tangible contribution to a world with less suffering from this devastating disease."