Due to COVID-19, diagnostics are in the limelight, and public and private investors are watching how the pandemic may impact the in vitro diagnostics (IVD) market in the future. As the sector receives an influx of investment, companies will be in strong positions to expand their portfolios. So, with 2022 around the corner – what are the investment trends to watch?
Fujirebio Europe NV launched two new cerebrospinal fluid (CSF)-based immunoassays for Alzheimer’s Disease (AD) on its Innotest platform. It’s the first product launch for the company following a collaboration agreement signed with Adx Neurosciences NV in September 2020. The assays will test for neuronal pentraxin-2 (NPTX2) and soluble triggering receptor expressed on myeloid cells 2 (STREM2). Both neurology biomarkers are linked to synaptic dysfunction and neuroinflammation which are considered core features of AD progression. Fujirebio said the new tests will support existing research for AD drug development.
Assure Tech (Hangzhou) Co. Ltd. made its debut on the Shanghai Stock Exchange Star Market and raised ¥1.2 billion (US$188 million) in the IPO. Its shares increased 19.28% in the middle of the first trading day but closed 6.73% lower the second day.
PARIS – The French National Agency for the Safety of Medicinal and Healthcare Products (ANSM), has published its latest annual report on the drugs and medical devices market in France. This body, placed under the supervision of the Ministry of Health, is responsible for monitoring all healthcare products throughout their cycle, for collating and analyzing reports of adverse reactions, and for implementing corrective action across the nation.
Patent subject matter eligibility has emerged as arguably the most controversial patent policy theme of the past two decades, one which has been most keenly felt in the world of in vitro diagnostics (IVDs). A new study pending publication suggests that venture capital (VC) investment in IVDs would have been $9.3 billion higher in the four years following the Supreme Court’s decision in Mayo v. Prometheus, a finding which the author said leads inevitably to the conclusion that the subject matter eligibility crisis “should receive Congress’ immediate attention.”
The European Commission (EC) posted a new explanatory note on Tuesday that provides guidance on the codes set under the European In Vitro Diagnostic Regulation (IVDR) to define the notified body (NB) scope of designation and qualification required for assessing a device. The clarifications explain how to use the different levels of codes to guide the proper allocation of resources, citing the anticipated challenges with limited experience and competency of NBs.
The European Commission (EC) unveiled on Monday its new joint implementation and preparedness plan for the European Union’s In Vitro Diagnostic Regulation (IVDR). It sets forth priority actions, noting “the implementation of the IVDR has proven to be a very challenging task,” exacerbated in the response to the COVID-19 pandemic “despite the efforts undertaken by all” to transition.
PARIS – Biosynex SA signed a binding offer to acquire 100% of the stock in Avalun SAS, a company developing the Labpad in vitro diagnostic device that provides rapid biological test results from small sample volumes. In Europe, Avalun is currently marketing a follow-up test for patients on anticoagulation therapy using antivitamin K agents, and a test for automated antigen detection for COVID-19.
The FDA’s operations have been badly hampered by the COVID-19 pandemic, but Jeff Shuren, director of the agency’s Center for Devices and Radiological Health (CDRH), said review times for most non-COVID product categories should resume their normal clip by the end of 2021. However, he acknowledged that the lag for in vitro diagnostics (IVDs) may not be fully resolved until 2022 because of the resources needed to review emergency use authorizations for tests for the SARS-CoV-2 virus.
PERTH, Australia – Australia’s TGA issued final guidance on clinical evidence requirements for medical devices in response to updated regulations that have resulted in changes to evidence requirements. Clinical evidence is required for all medical devices and in vitro diagnostics (IVDs) that are listed on the Australian Register of Therapeutic Goods (ARTG). The clinical evidence requirements apply when a device is first listed as well as over the lifecycle of the device. If safety issues are identified, the TGA may ask manufacturers to update clinical information to more accurately reflect risk.