NEW YORK ─ Siemens Healthineers' molecular diagnostics business is seeking a partner to help it develop a next-generation testing platform that it plans to launch in Europe within three years to compete with high-volume testing systems currently in the market.
As the company continues to develop, launch, and sell assays running on its existing Versant kPCR molecular diagnostic system, it is also "working behind the scenes to find the best possible solution for the long term," Corey Bouwman, the firm's head of molecular diagnostics, said recently on the sidelines of the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Lisbon, Portugal.
The firm is looking forward, he said, to when all of its assays, including legacy tests and those in development, will run on the new molecular diagnostic system. The firm would market the system alongside its Atellica and other clinical chemistry and immunoassay test systems, offering a complete testing solution involving all modalities to its customers.
Such an MDx system would take a few years to develop, said Bouwman, who has been tasked with spearheading its development by Siemens Healthineers' board of directors. Bouwman, appointed head of molecular diagnostics more than two years ago, came aboard with the goal of integrating the firm's molecular diagnostics products within its laboratory diagnostics portfolio.
The company intends to target hospital and reference laboratory customers with a system that runs assays developed by Fast Track Diagnostics (FTD), a Luxembourg-based molecular diagnostic test developer that it acquired in December 2017, as well as other molecular tests it developed before and after the FTD acquisition, Bouwman said.
With FTD, it acquired 80 platform-agnostic assays and syndromic panels suitable for adding to the menu of legacy tests on its Versant kPCR Molecular System.
Prior to the onset of the COVID-19 pandemic, Bouwman noted, the Siemens Healthineers molecular diagnostics business had a laser focus on the marketing of a menu of tests developed by FTD, but with the onset of the pandemic, it moved quickly to develop an RT-PCR SARS-CoV-2 assay to run on the Versant kPCR Molecular System.
In April 2020, the company received the CE mark for the SARS-CoV-2 test and system. A month later, the US Food and Drug Administration granted Emergency Use Authorization for the SARS-CoV-2 test for use with the BioMérieux EasyMag Extraction System and the Thermo Fisher Scientific Applied Biosystems 7500 Real-Time PCR Thermocycler. In July 2020, the FDA authorized an update to the instructions for use of the assay to add the Versant kPCR Molecular System as an additional extraction and amplification detection system.
"While kPCR has been a good solution for SARS-CoV-2 and other types of testing, it also has limitations, and nowadays many customers want a state-of-the-art system that enables you to load whichever test you want whenever you want and get results quickly with no hands-on time," Bouwman said.
Its Versant kPCR Molecular System enables the batch testing of up to 96 samples in about five and a half hours with a total estimated hands-on time of 30 minutes.
Though such batch testing is still in high demand because of its affordability and suitability for high volume testing, "one of the key elements of a state-of-the-art testing system is complete automation," Bouwman noted. "That means inserting a sample and getting results in a single workflow, and the customer would love to have tests completed within two hours" on a system that enables inexpensive testing and provides high throughput, he said.
One reason Siemens Healthineers is developing a new diagnostic testing platform is its expectation of an uptick in PCR testing demand in the coming years. The COVID-19 pandemic has altered the landscape for molecular diagnostic testing, increasing awareness of the modality. Meanwhile as laboratories have become more familiar with PCR testing, Siemens Healthineers anticipates PCR test demand will increase for a broad range of conditions, including demand from laboratories that had not previously done molecular testing.
"We are aware that there are a lot of molecular diagnostic systems out there that have been purchased specifically to detect SARS-CoV-2, but most of them" cannot run a test menu broad enough to be considered as a candidate for Siemens Healthineers' next MDx platform, Bouwman said.
Rather than evaluating current technologies and systems that it could purchase to run molecular tests, "we are strong believers that we should have a new platform," he said, adding that while molecular assay development is a core capability for Siemens Healthineers, molecular testing system development is not.
As a result, the firm is looking for a partner — an IVD company or academic collaborator — with whom it can develop the molecular diagnostic testing platform, but it is at the beginning of its search, according to Bouwman.
Siemens Healthineers will aim to develop a platform that provides greater testing flexibility than competing, high-volume molecular diagnostic platforms already in the market from companies such as Roche, Abbott, and Hologic, and that offers testing at more affordable prices than "expensive," lower volume, cartridge-based molecular diagnostic testing systems, he said.
Within three years, the company expects to have a new MDx platform in the market, with sales to laboratories in the European Union and other geographies that accept the new In Vitro Diagnostic Regulation (IVDR) for diagnostic tests.
It plans to have clearance from the US Food and Drug Administration to market the platform in the US a year later, Bouwman said, adding, "To grow and have a track record in the US, we need a platform which is adapted for customers in the US market, where we don't yet have a big market share."
Meanwhile the new platform would need to be approved under IVDR, a new law governing the regulation of IVDs, that is set to come into effect in Europe on May 26. The European parliament voted in December to stagger the grace periods for tests cleared before then, but any tests that do not have a CE-IVD mark prior to May 26 will require assessment by a designated notified body under the IVDR.
Bouwman added that while the company develops new MDx assays and looks to port tests onto a new platform, it intends to follow guidance from a market research project conducted last year. The project clarified that "the biggest part of the market in infectious disease testing is respiratory," he said. "Gastrointestinal testing panels represent the second biggest [market], while STI panels and the detection of transplant infections are also of particular interest."
In the near term, based on current customer feedback, Erlangen, Germany-based Siemens Healthineers is finalizing the development of a multiplex test to detect and differentiate influenza A, influenza B, SARS-CoV-2, and human respiratory syncytial virus on the Versant kPCR Molecular System.
According to Michael Schleichert, head of the firm's molecular assay R&D group, it expects to soon launch the test with CE-IVD marking and a focus on marketing the assay to hospital laboratories in Europe, the Middle East, and Africa region where most of its MDx systems are placed.
"With the pandemic becoming endemic, we believe that SARS-CoV-2 will be one of many respiratory pathogens laboratories want to monitor," Schleichert said at ECCMID.
He noted that overall, Siemens Healthineers is already marketing MDx-based options for respiratory testing, and one of its FTD panels differentiates among 21 respiratory pathogens.