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In Brief This Week: Siemens Healthineers, Illumina, Thermo Fisher Scientific, and More

NEW YORK – Siemens Healthineers this week announced it will invest more than $32 million in its Glasgow Laboratory Diagnostics manufacturing facility in Newark, Delaware. As part of the expansion, the company said it will relocate important test manufacturing to this facility, streamline some of its processes, and further improve the efficiency of its test delivery.

The investment, which extends over 24 months, will enable Siemens Healthineers to manufacture more than 20 types of diagnostic tests in Delaware. The project is part of an initiative to drive greater efficiency, productivity, and stability across its diagnostics supply chain, the firm said. The Newark facility employs more than 1,300 employees, and manufactures more than 120 assays that run on Siemens' instrument platforms, including the Atellica Solution, Advia Chemistry, Dimension, Dimension Vista, Syva Drug Testing, and Stratus CS instruments.

Illumina said this week that it has expanded its presence in Latin America by launching subsidiaries in Colombia and Mexico. Illumina Colombia will operate out of Bogota and Illumina México Productos de Biotecnología will operate out of Mexico City. The entities will also support local and nearby Illumina channel partners in the Caribbean and Central and South America.

The US Food and Drug Administration this week revoked its Emergency Use Authorization for Thermo Fisher Scientific’s TaqPath COVID-19 MS2 Combo Kit 2.0. In a letter to the FDA dated Sept. 22, the company requested that the EUA be revoked, indicating that it has decided not to commercially support the TaqPath COVID-19 MS2 Combo Kit 2.0 at this time.

Guardant Health’s stock was down around 17 percent and NeoGenomics’ stock up about 6 percent in midday trading on the Nasdaq this Friday, following speculation by Bloomberg that Guardant, a leader in cancer liquid biopsy testing, is exploring an acquisition of the cancer diagnostics and testing firm. In a note to investors, SVB Leerink Research’s Puneet Souda wrote that although the deal would be "growth and margin dilutive," the potential combination could also be a strategic positive for Guardant, "strengthening its commercial channel in pathology."

Selux Diagnostics said this week that its Next Generation Phenotyping platform has received breakthrough device designation from the US Food and Drug Administration for use with positive blood culture and sterile body fluid samples. NGP provides rapid, phenotypic antimicrobial susceptibility test results across all sample types from positive blood bottles and isolated colonies, which can lead to actionable results to indicate which therapies may effectively treat a patient's infection, Selux said.

Aspira Women's Health said this week that it has reached agreements with four organizations for the transfer of its technology. The Austin, Texas-based firm did not disclose the organizations’ names but said two are women's healthcare groups with more than a combined 750 providers caring for more than 950,000 patients each year, and two are independent laboratories providing services across five states. The agreements allow them to perform genetic testing for hereditary cancer and carrier screening, or OVA1plus testing in house using the Aspira Synergy platform, which allows for point-of-care testing. Further terms of the deals were not disclosed. Aspira launched its technology transfer program, Aspira Synergy, during Q2 2021.

Liquid biopsy firm Nonagen Bioscience said this week the US Food and Drug Administration has granted breakthrough device designation to the firm's Oncuria noninvasive bladder cancer test for predicting therapy response. The multiplex immunoassay measures 10 protein biomarkers in a single voided urine sample. When combined with a weighted algorithm, the biomarker levels can aid in predicting how patients may respond to the installation of bacillus Calmette-Guerin, an attenuated tuberculosis vaccine that acts as a nonspecific immune system stimulant. It has shown success as a treatment in eradicating residual bladder cancer, but more than half of patients who receive the treatment fail to respond to it.

Yourgene announced this week that it expects to deliver revenues for the first half of FY 2022 of at least £15 million ($20.2 million), compared to revenues of £8.2 million in the year-ago period and full-year 2021 revenues of £18.3 million. The company also said it is operating at its capacity of 100,000 tests per month and has now doubled that capacity in anticipation of continued growth in sample numbers.

Fujifilm Medical Systems and Fujifilm Healthcare Americas this week announced that the two companies have merged and are operating under the name Fujifilm Healthcare Americas. Henry Izawa, president and CEO of Fujifilm Healthcare Americas, will lead the combined organization. Izawa announced a new executive management team composed of leaders from both businesses to drive a smooth integration, the firm said.

SpeeDx announced this week that it has invested in SynGenis, an oligonucleotide manufacturing firm based in Western Australia. Terms of the deal were not disclosed. Sydney-based SpeeDx said the investment will secure a local source for raw materials used in molecular diagnostics and enable the scale-up of manufacturing.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.