POC MOLECULAR DIAGNOSTICS FULL
POC MOLECULAR DIAGNOSTICS PORTABLE

POC MOLECULAR DIAGNOSTICS FULL

The division provides scalable and customisable assembly solutions with a full suite of Pre-Production Services, ranging from consultancy advice to full engagement such as design for manufacturing (DFM) analysis, PFMEAs (process failure modes effects analysis), process range studies, proof of principle feasibility studies, prototype component builds, process characterisation, and clean room assembly of design verification build or clinical trial builds. Mikron Automation enables manufacturers to meet their end goals while reducing their time to market. At these sites, it develops fully automated solutions from lab stations through to clinical pilot lines, using a broad range of standard, proven platforms to deliver optimal solutions for a vast range of devices, including molecular diagnostics and POC tests. Headquartered in Boudry (Neuchâtel) and employing more than 750 people, the division also has sites in Denver (USA), Singapore and Shanghai (China). “The standard strip cutting devices began back in the ‘90s and molecular diagnostics back in 2015, so our customers can rely on our experience and expertise in this field.” “We are not a start-up company for diagnostic device manufacturing,” remarks Bauer. Its Mikron Automation division has built a reputation for high quality, process expertise, innovation, risk management, and commitment to its customers, installing 3,900 assembly and testing systems worldwide for clients in the pharmaceutical and MedTech industries. Mikron has more than 50 years of experience providing pharmaceutical assembly system expertise and works in full accordance with FDA, GAMP 5 and GMP. To succeed, manufacturers must understand the technical challenges that come with devices this critical and sophisticated and ensure precision is built into their production processes. To compose one full molecular device, there are many, many components.”īut in the highly regulated world of medical devices, there is no margin for error, and quality standards are consistently high. “In molecular devices, you have a lot of processes, and they are very complex because you are dealing with different reagents and with a variety of materials. “For strip devices, you have just a few processes for the device assembly,” says Jean-François Bauer, head of marketing and business development at Mikron Automation. Molecular devices, meanwhile, require the assembly of what amounts to a small laboratory, and present additional complex challenges.

While nucleic acid amplification tests – a type of viral diagnostic test for a virus or bacterium that detects genetic materials rather than antigens or antibodies – can provide a shorter turnaround time, they come with challenges, ranging from their complex nature to the intensity of labour required in their creation. Traditional approaches to POC testing have typically required overnight culturing and pathogen isolation. As such, POC diagnostics are well positioned to challenge traditional centralised laboratory methods.

POC MOLECULAR DIAGNOSTICS PORTABLE

In addition, there has arisen the need for small or portable systems to support testing in more remote areas.With the pandemic increasing the demand for these devices, manufacturing companies have been racing to make the next-generation of POC platforms faster, easier, and more reliable. There have been a range of challenges related to supply chain management, which relate primarily to laboratory tests. We said that 'along with the spread of COVID-2019 has arisen the issue of making diagnostic tests available on a large scale. In 2020, Kalorama predicted that molecular point-of-care was uniquely qualified to respond to a pandemic such as COVID-19. These systems employ cartridges and either do not require a technician or offer tests that reasonably will be CLIA-waved in the next few years. The molecular care market consists of small-scale systems that can be used in a clinic setting and with a result time fast enough to be useful in point-of-care. Kalorama does not include all tests run on small machines in its market assessment. Kalorama Information, part of Science and Medicine Group (parent company of ) has covered molecular point-of-care on a yearly or biyearly basis since 2013. The concept of molecular point-of-care is to mix the accessibility of POC testing with the accuracy of molecular technology.

Poc molecular diagnostics