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Hologic (HOLX) Launches Novodiag System for On-Demand Testing

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Hologic, Inc. (HOLX - Free Report) recently launched the Novodiag system for on-demand molecular testing in Europe. This launch follows the company’s acquisition of Mobidiag Oy in June 2021. It is expected to bring the benefits of the Novodiag system to a wide range of European customers.

The Novodiag system is a completely automated molecular diagnostic solution intended for on-demand testing of infectious diseases and antimicrobial resistance. It combines real-time PCR and microarray capabilities to detect multiple pathogens in a single sample, offering a simple and quick way to identify patients most at risk utilizing targeted and syndromic on-demand testing.

The recent launch of the Novodiag system expands Hologic’s leading diagnostic molecular scalable solutions offering. Per management, the addition of the Novodiag system to the company’s diagnostic molecular scalable solutions portfolio will provide more customers in Europe with a broader range of solutions — from single patient rapid testing to population-level screening — that match their requirements.

More on the Novodiag system

The Novodiag system’s CE-IVD test menu consists of highly multiplexed on-demand assays that can identify gastrointestinal infections and antibiotic resistance, as well as a targeted assay for SARS-CoV-2 detection. In the meantime, a robust pipeline is also in development.

The Novodiag system complements Hologic’s Panther System and Panther Scalable Solutions. It broadens Hologic’s offerings and enables the company to meet increasing diagnostic testing demand from customers across small to large laboratories. The Panther System is a best-in-class, fully automated, sample-to-result platform intended for use across laboratories of varying throughputs. Hologic's current diagnostic offering is anchored around the Panther system.

Industry Prospects

Per a report published in Grand View Research, the global molecular diagnostics market size is expected to see a CAGR of 3.9% from 2021 to 2028. Factors such as a surge in geriatric population, external funding for research and development, rising demand for Point-of-Care (PoC) testing and rapid technological advancements are driving the market. The growing prevalence of infectious diseases is also expected to fuel market growth during the forecast period.

Given the market prospects, Hologic’s recent launch of the Novodiag system for on-demand molecular testing in Europe seems well-timed.

Notable Developments

In September 2021, Hologic launched an expanded Omni suite in Europe, Africa and the Middle East (EMEA). The expanded Omni suite is intended to optimize diagnostic and operative hysteroscopy across EMEA.

In July 2021, the company gained the CE Mark in Europe to use saliva samples with the Aptima SARS-CoV-2 assay. This test is a molecular diagnostic assay that runs on the fully automated Panther system. It can detect the genetic material of the pathogen causing COVID-19. The Aptima SARS-CoV-2 assay also received the CE Mark for use with nasopharyngeal and nasal swabs as well as other specimen types.

Competitive Niche

The global molecular diagnostics market is competitive with the presence of a large number of notable players. To gain a competitive advantage, manufacturers must upgrade their products in terms of specificity, accuracy and other factors.

In this regard Becton, Dickinson and Company (BDX - Free Report) , or BD, recently launched a fully automated high-throughput diagnostic system utilizing robotics and sample management software algorithms to set a new standard in automation for infectious disease molecular testing in core laboratories and other centralized laboratories across the United States. The BD COR System combines and automates the entire molecular laboratory workflow, from sample processing to diagnostic test result.

Bio-Rad Laboratories, Inc. (BIO - Free Report) collaborated with Seegene to develop and commercialize infectious disease molecular diagnostic products. The terms of the agreement require Seegene to supply diagnostic tests for use on Bio-Rad's CFX96 Dx Real-Time PCR System, for pending clinical development in the U.S. markets as well as to pursue approval from the from FDA.

Abbott Laboratories (ABT - Free Report) , too, has been progressing well in the molecular diagnostics space with the receipt of the CE Mark for its Panbio COVID-19 Antigen Self-Test. The Panbio test has been authorized for direct consumer sale and for use in adults and children, with or without symptoms, to provide quick and convenient coronavirus testing. The Panbio test is an easy-to-use, minimally invasive nasal swab test that permits self-collection of specimens and delivers results in 15 minutes.