Skip to main content
Premium Trial:

Request an Annual Quote

With Exit From PCR Business, Siemens Healthineers Narrows Focus of Remaining Molecular Tools


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.

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 as other functionalities. She noted that the firm is also bringing to market new automation track additions that could further help improve lab efficiency.