08/04/2024, 10:07 With Exit From PCR Business, Siemens Healthineers Narrows Focus of Remaining Molecular Tools | 360Dx
With Exit From PCR Business, Siemens Healthineers
Narrows Focus of Remaining Molecular Tools
Mar 22, 2024 | Greg Cima
Premium
Due to incorrect information from the company, the story previously stated Siemens would end
sales of the Versant kPCR Molecular System. The story has been corrected to clarify that the
platform is still available as Siemens evaluates its plans.
NEW YORK – With the pending closure this year of Siemens Healthineers' Fast Track Diagnostics
business, the firm has shelved its plans to expand into clinical PCR-based testing and limited
almost all of its remaining molecular testing products to research-use tools.
Erlangen, Germany-based Siemens Healthineers acquired Luxembourg-based Fast Track
Diagnostics (FTD) in 2017 for an undisclosed sum as part of a broader strategy to compete in the
molecular diagnostics space. Just two years ago, management anticipated rising demand for PCR
testing and even expressed hopes that the firm would develop a testing platform to consolidate the
firm's then-growing menu of molecular tests.
The FTD acquisition gave Siemens about 80 platform-agnostic PCR-based assays and syndromic
panels. However, with the recent decision to close FTD and the firm's ongoing evaluation whether
to end of sales of the CE-IVD-marked Versant kPCR Molecular System, the firm is poised to exit the
clinical molecular testing space.
Lisa Rose, executive VP of Core Laboratory Solutions in Siemens's diagnostics business, said that
Siemens will remain involved in research-use molecular testing, but the firm is prioritizing uptake in
the firm's non-molecular instruments for use in laboratories and at the point of care as well as the
development of assays that employ novel biomarkers in fields such as neurology, sepsis and other
infectious diseases, inflammation, and cardiology. Those instruments include Siemens' recently
completed lineup of Atellica immunoassay and clinical chemistry analyzers as well as its
coagulation, hematology, allergy, and plasma protein analyzers.
While sales of FTD's PCR assays surged during the COVID-19 pandemic, demand for those tests
has tailed off with the pandemic largely in the rearview mirror, and Siemens' diagnostics business
decided to narrow its focus, Rose said. FTD secured CE marking for its SARS-CoV-2 assay in April
2020 and US Food and Drug Administration Emergency Use Authorization for the test a month later.
With demand for COVID-19 tests waning, Siemens last year also discontinued sales of its Clinitest
Rapid COVID-19 antigen tests, which had generated €121 million in revenues during the fiscal year
ended Sept. 30, 2023, down from €1.5 billion in fiscal 2022.
Siemens has also been selling in Europe FTD's CE-IVD-marked multiplex assays for the detection of
infectious causes of respiratory diseases, vesicular rash, stool parasites, and viral meningitis,
although dozens of other FTD assays remained for research use only, the company said on its
website. In announcing Monday its decision to shut down FTD, Siemens said that the business had
become only a minor player in molecular diagnostics, and sales of its tests accounted for only a
very small portion of the company's total diagnostics revenues.
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08/04/2024, 10:07 With Exit From PCR Business, Siemens Healthineers Narrows Focus of Remaining Molecular Tools | 360Dx
While Rose said this week that Siemens had also decided to end sales of the Versant kPCR
Molecular System, company officials clarified on Friday that the company is still reviewing its plans
for the product. They said in a statement that the system has a very small number of customers.
The Versant system has a batch capacity of 96 samples, it has been validated for use with the FTD
SARS-CoV-2 assay and an FTD syndromic assay for the differentiation of infections with SARS-
CoV-2, influenza A and B, and RSV, and it is also used with laboratory-developed tests and third-
party assays, according to Siemens.
Rose noted that the decision to exit FTD's PCR business was separate from the firm's multiyear
transformation of its larger diagnostics business. The company has been cutting costs to become
more streamlined and ending sales of legacy instrument lines in favor of consolidation into the firm's
Atellica portfolio.
Through that transformation, the firm aims to deliver about €300 million ($326 million) in cost
reductions by 2025. Company officials reported last month that it was starting to see the effects of
those efforts.
In the broader diagnostics business, Rose said that the firm has been collaborating with Novartis on
the development of its Advia Centaur serum neurofilament light chain (sNfL) assay, which is used to
guide treatment of patients with relapsing multiple sclerosis.
In 2022, the firm secured FDA breakthrough device designation for the immunoassay, which is used
for the quantitative measurement of sNfL as a marker of nerve cell injury in adult MS patients.
In the molecular research space, the company announced in November that it had secured a three-
year, $5.5 million contract with the US National Institute of Allergy and Infectious Diseases to
develop a next-generation sequencing-based test to identify within six hours of a blood draw the
causes of sepsis and the likely resistances of those organisms to antimicrobials. That project is a
collaboration with Janus-I Science and the Louis Stokes Cleveland Department of Veterans Affairs
Medical Center. Rose said that inflammation and sepsis are key areas of assay development for
Siemens.
She added that the firm's diagnostics business has been collaborating with outside partners and
internally with its own imaging business on multiple research projects to develop neurological
disease diagnostics, particularly prognostic assays that could be used for the early detection of
dementia risk and Alzheimer's disease progression, as well as assays that could aid patient-specific
therapy selection for Alzheimer's disease patients.
"We have a very robust innovation team actually in our broader Siemens Healthineers group, and
then we do have a lot of collaborations across Varian [Medical Systems] to really bring novel clinical
value to the marketplace," she said.
Research into potential Alzheimer's biomarkers and treatments has become a hot market recently,
and Siemens, Rose noted, is working with key opinion leaders to maintain a robust portfolio in the
space.
The firm is also building its relationships with pharma firms to develop companion diagnostics for
use in the treatment of patients who have MS, neurological disease, and liver disease.
As for Siemens' Atellica line, Rose said that the instruments are being developed to incorporate
features that could help laboratories and healthcare networks to address shortages in trained
laboratorians and other lab staff by improving the efficiency and consistency of testing workflows.
The results, she said, include features for automating tasks such as the sorting, de-capping, and
resealing of samples and providing consistent interfaces and operations across instruments, as well
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08/04/2024, 10:07 With Exit From PCR Business, Siemens Healthineers Narrows Focus of Remaining Molecular Tools | 360Dx
as other functionalities. She noted that the firm is also bringing to market new automation track
additions that could further help improve lab efficiency.
Filed Under Molecular Diagnostics Business News PCR COVID-19
Infectious Disease North America Europe Siemens coronavirus
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