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Momentum in Multiplex Testing for IVD

Diagnostic testing is now a cornerstone of healthcare, assisting physicians in diagnosing conditions and prescribing treatments. Demand for in vitro diagnostic (IVD) testing has remained strong across various segments, with sales generally increasing throughout 2023. Global IVD market sales surpassed $100 billion in 2023, according to In Vitro Diagnostic (IVD) Trends and Market Update: March 2024, a new report by Kalorama Information.  

Factors such as the introduction of new products, changes in global health spending, regulatory updates in major markets, and evolving disease trends contribute to a constantly evolving market landscape that remains resilient.

Several segments within the market are experiencing significant growth and are attracting industry attention. Overall, the IVD market continues to be dynamic, with ongoing innovations driving its evolution. Particularly noteworthy is multiplex disease testing.

Multiplex testing is a molecular biology technique that provides amplification of multiple targets from a single sample. Multiplex testing is especially useful in infectious disease identification. Over the past year, more and more multiplex tests have entered the market mainly to differentiate COVID-19, Influenza A & B and RSV from a single sample. Since the FDA approval of the first multiplex PCR panel for the detection of two or more respiratory pathogens, multiplex testing has grown in use and preference for critical care decision making.

There have been several recent additions to the multiplex testing market. These include:

  • Seegene launched its new Allplex SARS-CoV-2 Fast PCR Assay that targets three COVID-19 genes to detect COVID-19. The test is a PCR test that reduces the total turnaround time for results by a third and expanding testing capacity.
  • Labcorp received FDA EUA for the first non-prescription at-home collection kit for combined COVID-19, flu and RSV detection. The Pixel by Labcorp kit will be available through Labcorp OnDemand digital health platform.
  • Lucira Health received CE marking for both COVID-19 & Flu and COVID-19 molecular tests. Both tests are nucleic acid amplification tests (NAAT) with sensitivity equal to lab-based PCR assay but can run on a palm-sized device with no separate instrument or reader. The new assays provide results within 30 minutes. The Lucira COVID-19 test has been available in the US, Singapore, Canada, Israel, and Taiwan. The COVID-19 & Flu assay uses the same platform and will independently test for COVID-19, Flu A and Flu B.
  • LumiraDx received EUA for its multiplex test that can detect and differentiate strains of influenza and COVID-19. LumiraDx received FDA EUA for its SARS-CoV-2 & Flu A/B RNA STAR Complete Assay. This test is a multiplex test which uses the proprietary qSTAR technology allowing for high-throughput, direct amplification with highly sensitive results on open molecular platforms. The test simultaneously detects and differentiates influenza A and influenza B and SARS-CoV-2 infections within 20 minutes or less. The qSTAR technology uses a single-step direct method for nucleic acid extraction and amplification. 
  • AliA BioTech’s Lab-on-Chip platform brings multiplex testing to the forefront. The platform is a POC test that provides up to 30 results from a single drop of blood. The company’s analyzer and its biochip panels for respiratory infections and tropical fever have obtained CE marking and the company is actively pursuing regulatory approval in the United States, China, and Southeast Asia.
  • Becton Dickinson received FDA EUA for a new multiplex molecular diagnostic combination test for SARS-CoV-2, Influenza A+B and RSV. The test will be used on the BD MAX Molecular Diagnostic System. For the test, a single nasopharyngeal swab would be needed to identify and distinguish if a patient has COVID-19, flu or RSV or some combination of the three. The results are available in two hours.
  • Rize Laboratory received FDA EUA for its SARS-CoV-2019 Multiplexed Assay Test that is intended for the qualitative detection of RNA from SARS-CoV-2 from a nasal swab. Testing is limited to Rize Laboratory and results are used for the detection and identification of SARS-CoV-2 RNA.
  • Quest Diagnostics has made changes to improve testing and access for respiratory illnesses. Quest is broadening its access to its multiplex test to detect flu and COVID-19 with a self-collect sample instead of the patient having to make an appointment at the testing site where the clinician performed the test. This change was done to accommodate the rising flu cases in the U.S. and to differentiate influenza-like illnesses that may be confused with influenza. 
  • Visby Medical was granted FDA EUA for its instrument-free respiratory health test. The Respiratory Health Test is a rapid polymerase chain reaction (PCR) test that detects and differentiates upper respiratory infections caused by influenza A, influenza B and SARS-CoV-2. Results are available at the POC in 30 minutes.

Many multiplex tests of various types are available on the market with many more in development.

About the Report

In Vitro Diagnostic (IVD) Trends and Market Update: March 2024 by Kalorama Information provides the most current insights into important trends shaping the IVD market. This report reflects the latest information available.

In In Vitro Diagnostic (IVD) Trends and Market Update: March 2024, you’ll discover:

  • What’s Driving Growth in the IVD Market in 2024
  • What Major Trends are Affecting the Market in 2024
  • What Product Trends and New Developments Will Shape the IVD Market in 2024

Trends highlighted throughout 2023 and into 2024 include:

  • Growing interest in multiplex disease testing
  • Increasing interest in digital diagnostics, combining data and analytics with traditional IVD
  • Continued advancement of AI technologies
  • Growth in rapid and POC testing
  • And much more!

To purchase the report, view the table of contents, or for more information visit: https://kaloramainformation.com/product/ivd-trends-update-march-2024/.

About Kalorama Information

Kalorama Information, part of Science and Medicine Group, is the leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), biotechnology, medical devices, and pharmaceuticals. Kalorama Information produces dozens of reports a year. The firm offers a Knowledge Center, which provides access to all published reports.

Kalorama Information’s studies feature independent primary research conducted by experienced analysts. Researchers build their market analysis independently from published databases, validating data with inside industry contacts and extensive secondary research, so you can have confidence that you’re getting your information from the most trusted source in the industry!