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Siemens Healthineers Developing Molecular Kit for Coronavirus Detection

NEW YORK – Siemens Healthineers said Thursday that its molecular diagnostics business is developing a test kit to detect SARS-CoV-2 that should be made available for coronavirus testing in a few weeks.

The firm anticipates obtaining Emergency Use Authorization from the US Food and Drug Administration and an Emergency Use Assessment and Listing from the World Health Organization to enable use of the kit for SARS-CoV-2 testing in hospital labs. Later, the company anticipates seeking CE mark certification that will enable the kit to be marketed in the European Union and other countries that recognize the designation.

"As always it is a difficult to say exactly when the regulatory approvals will come through, but we expect them to occur in weeks and not in months," Sebastian Kronmueller, head of molecular diagnostics at Siemens Healthineers, said in an interview.

The molecular diagnostic test consists of reagents that operate with commercially available RT-PCR molecular diagnostic systems. "The assay is designed to identify the virus in less than three hours so that healthcare professionals can proceed as quickly as possible with necessary next steps on their patients’ triage paths," Kronmueller said.

The firm is conducting a controlled rollout of the test for research use, and it is simultaneously expanding its production capacity. An undisclosed large "clinical partner" in Luxembourg is validating research-use versions of its SARS-CoV-2 Assay in preparation for regulatory submissions, Kronmueller said.

Siemens Healthineers is leveraging several locations across the company to scale up production and "to make sure we react in the right way to the huge need for having kits available for clinical management," Kronmueller said.

The SARS-CoV-2 Assay has been optimized for use with the BioMérieux EasyMag Extraction System and the Thermo Fisher Scientific Applied Biosystems 7500 Real-time PCR Thermocycler, but it can be validated for use with many other laboratory molecular instruments, he said.

Near-term regulatory clearances are likely to require use of the kit with these instruments, but Siemens Healthineers "is encouraging its customers" to seek validation on other systems as well, Kronmueller added.

When the assay is available, it could help alleviate some of the supply chain issues hampering test rollout during the pandemic, he said, adding that "from a need perspective, it is important that people have reagents available to do this kind of testing."

He believes that both point-of-care and laboratory tests are important for patient management during the pandemic. Point-of-care tests that conduct one or a few tests per run for each instrument are important assets for physician practices, but more laboratory systems are needed to handle demand during the pandemic, he said.

"With this system you can run 50 to 300 samples, depending on the setup, in a single run," Kronmueller said. "We expect that the assay will be widely used in medium-throughput laboratories." 

The lack of reagents as well as swabs and sample tubes remains a bottleneck in testing during the pandemic, Robert Boorstein, medical director for oncology and esoteric testing at Brooklyn, New York-based Lenco Diagnostic Laboratories, said in an interview.

If the Siemens Healthineers assay can enable the completion of 300 samples in a single run, that will support its adoption, Boorstein said. The Siemens assay, at least initially, will be used where the BioMérieux extraction system and Thermo Fisher thermocycler are already in place, he added.

"In my opinion, systems that have distinct extraction and analysis steps tend to have lower capacity and have greater demands for skilled labor," Boorstein said. "My guess is that the bulk of the testing over the next month will be on the large automated platforms, and I expect to also see ramp up of rapid testing in hospital settings."

High-capacity automated platforms are already available with Emergency Use Authorization, including those marketed by Roche, Hologic, and Abbott, among others, he noted.

Kronmueller said that with most laboratory testing being done using molecular tests, Siemen's Healthineers Fast Track Diagnostics business ─ which it acquired in 2017 and is now part of its molecular diagnostics business ─ is playing an important role in enabling the firm to participate in COVID-19 testing.

Overall, the firm's molecular business employs about 300 people, or approximately 5 percent of its diagnostics business workforce, Kronmueller said.

In recent years, its diagnostics business has focused heavily on marketing its Atellica next-generation immunoassay and clinical chemistry systems, which are high-throughput laboratory platforms that run tests for many medical conditions.

Siemens Healthineers sees parts of its product portfolio already contributing to patient care during the pandemic. Clinicians are currently using the firm's computer tomography and X-ray systems for patient imaging and blood-gas analyzers to ensure that coronavirus patients are getting enough oxygen. On Tuesday, the company announced that it had received FDA clearance for its RapidPoint 500e Blood Gas Analyzer, which is used to monitor critically ill patients, including those with COVID-19, in acute care settings.

The company anticipates that for COVID-19 testing, its SARS-CoV-2 assay will run in laboratories along with a Fast Track Diagnostics multiplex real-time PCR panel that enables testing for 21 respiratory pathogens.

The panel enables testing for influenza strains, including A, B, and H1N1, as well as testing for human rhinovirus; human coronaviruses NL63, 229E, OC43 and HKU1; human parainfluenza viruses 1, 2, 3 and 4; human metapneumoviruses A/B; human bocavirus; human respiratory syncytial viruses A/B; human adenovirus; enterovirus; human parechovirus; and Mycoplasma pneumoniae.

A syndromic approach enabled by such a multiplex panel will play an important role in testing during and after the pandemic, Kronmueller said, because a panel that can differentiate one respiratory condition from another is needed by clinicians trying to triage patients. Clinicians need speedy answers not just to enable the prescription of appropriate treatments to patients, but also to prevent the transmission of infections to others while patients are being tested, he added.

In this crisis, "SARS-CoV-2 is not the only dangerous thing that can happen," Kronmueller said. "If you are immunocompromised, the flu can kill you." Clinicians are hard-pressed to keep up with caseloads and currently need to devote most of their testing to COVID-19, he said, "but in a few months when the pandemic is hopefully subsiding, it will become more important … to run a respiratory panel along with a coronavirus test."