DxTerity | June 13, 2022
DxTerity Diagnostics today announced the commercial launch of their IFN-1 Test for patients with Systemic Lupus Erythematosus (SLE or lupus). The IFN-1 Test supports the advancement of precision medicine to improve the lives of patients living with lupus.
DxTerity's test measures a key biomarker, Type-1 Interferon (IFN-1), an important indicator of SLE disease severity and prognosis. High IFN-1 levels have been shown to lead to higher likelihood of disease severity and an increased risk for the development of lupus nephritis in SLE patients. The DxTerity IFN-1 Test is the first commercial IFN-1 gene expression assay.
Patients living with lupus can find it difficult to predict and interpret symptoms. Each person's experience is unique and not all patients respond to standard treatments. Disease symptoms and treatment failure may be the result of a person's specific genomic activity. The DxTerity IFN-1 Test measures the expression levels of 4 genes associated with IFN-1 activity and identifies a patient as IFN-1 high or low. This information can be used by a healthcare provider to guide treatment.
Rheumatologists have long been faced with limited therapy options for lupus management. With the recent FDA approval and availability of the Type-1 Interferon receptor blocking therapy anifrolumab (Saphnelo®), lupus patients have a new and much needed treatment option.
We are excited to launch the DxTerity IFN-1 Test, the first available IFN-1 gene signature test to provide information regarding a person's unique genomic activity, It is our mission to transform patient care by developing diagnostic tools that support a personalized approach to the treatment of immune-mediated disease."
Bob Terbrueggen, Ph.D., Founder and CEO of DxTerity Diagnostics.
DxTerity Diagnostics is an ISO 13485-certified genomics company with a CLIA-licensed, CAP-accredited laboratory based near Los Angeles, CA. DxTerity Diagnostics develops simple, fast, and affordable genomic tests for disease diagnosis and disease monitoring.
CellCarta | May 23, 2022
CellCarta, a leading global provider of precision medicine laboratory services, announced today the acquisition of the commercial rights to the antibody panels and assays from Precision Assays, a leader in next-generation targeted proteomics testing solutions. A spin-off from Fred Hutchinson Cancer Center ("Fred Hutch"), Precision Assays develops and deploys high-end multiplex quantitative immuno-MRM mass spectrophotometry-based assays for its pharmaceutical and biotech industry clients.
The acquisition from Precision Assays of its large spectrum of targeted mass spectrometry assays characterized according to the National Cancer Institute's Clinical Proteomic Tumor Analysis Consortium (CPTAC) Tier 2 guidelines greatly expands CellCarta's capabilities in off-the-shelf multiplex protein quantification offerings ready for deployment in immuno-oncology clinical and pre-clinical studies.
Precision Assays' large portfolio of robust assays characterized according to CPTAC guidelines and its established proof of concept data will enable CellCarta to confidently support its clients' exploratory studies and therapeutic development strategies, offering them key solutions to address important clinical challenges and move their immuno-oncology programs forward. Given CellCarta's expertise in protein quantitation, these immuno-MRM panels can further be validated to support secondary and primary clinical endpoints."
Lorella Di Donato, Chief Operating Officer of CellCarta, Immunology and Proteomics Divisions.
Based on technology licensed from Fred Hutch, Precision Assays' platform is uniquely positioned to fully capture the unique advantages of multiplex protein quantification using targeted mass spectrometry. Founder Dr. Amanda Paulovich, a professor in the Clinical Research Division at Fred Hutch who holds the Aven Foundation Endowed Chair, is an internationally recognized pioneer in targeted mass spectrometry and a clinically trained oncologist. Dr. Paulovich has set best-in-class standards to support precision medicine studies in cancer-specific protein expression analysis in a variety of matrices from FFPE cancer tissue biopsies to clinical serum-based samples. Precision Assays is one of the few CROs to offer large and immuno-oncology relevant multiplex off-the-shelf panels and is at the forefront of targeted-mass spec proteomics-based research.
As a global CRO with expertise in targeted mass spectrometry and specializing in biomarker testing to support precision medicine, CellCarta is an ideal partner to deploy and industrialize our platform to support discovery, translational and clinical research, especially in precision medicine and immuno-oncology."
CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with 11 facilities located in Canada, USA, Belgium, Australia, and China.
Sartorius Stedim Biotech | August 09, 2022
Sartorius Stedim Biotech, a leading international partner of the biopharmaceutical industry, has agreed to acquire 100 percent of Albumedix Ltd. from private investors. The Nottingham, UK-based company provides best-in-class recombinant albumin-based solutions. Recombinant human albumin is an important component for the biopharmaceutical industry required for various applications, for example as an animal-free additive to cell culture media and for the stabilization of vaccines and viral therapies. The business, founded in 1984, has more than 100 employees and is expected to generate revenue of approximately £33 million in 2022 with a significant double-digit EBITDA margin. The agreed purchase price amounts to approximately £415 million. The transaction is subject to regulatory approval and is expected to close before the end of the third quarter of 2022.
"Albumedix will be an important addition to Sartorius Stedim Biotech's advanced therapy solutions, particularly regarding our cell culture media business, as it will enable us to strengthen our position as a relevant supplier of innovative chemically defined media and critical ancillary materials. This market offers high growth potential due to the increasing regulatory requirements as well as rising demand for the use of recombinant human albumin in near-patient applications. Albumedix will also add important formulation excipients to our vaccine production solutions, allowing us to expand our existing customer relationships and forge new ones,"
René Fáber, member of the Board of Directors and Deputy CEO of Sartorius Stedim Biotech
"We are delighted to be joining forces with Sartorius Stedim Biotech and look forward to accelerating our ambitious growth plans in delivering critical solutions to our global customers. We have been highly impressed with Sartorius Stedim Biotech's knowledge and capabilities in the bioprocessing markets, and we are excited to join this purposeful journey. We believe Sartorius Stedim Biotech will bring tremendous value in strengthening our market reach and broadening our innovation capacity, as well as significantly scaling up our existing platform. We remain focused on our promise of empowering excellence in the life science industry," said Jonas S. Møller, CEO of Albumedix.
The existing 72,000-square-foot Albumedix site in Nottingham will be established as a center of excellence for innovation and GMP-compliant production of critical raw materials in Sartorius Stedim Biotech.
Milbank LLP provided legal counsel to Sartorius Stedim Biotech in this transaction. William Blair acted as financial advisor to Albumedix, and Eversheds Sutherland provided legal counsel.
This press release contains forward-looking statements about the future development of the Sartorius Stedim Biotech Group. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such statements. Sartorius Stedim Biotech assumes no liability for updating such statements in light of new information or future events. This is a translation of the original French-language press release. Sartorius Stedim Biotech shall not assume any liability for the correctness of this translation. The original French press release is the legally binding version.
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international partner of the biopharmaceutical industry. As a total solutions provider, the company helps its customers to manufacture biotech medications safely, rapidly and economically. Headquartered in Aubagne, France, the shares of Sartorius Stedim Biotech S.A. are quoted on the Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and an international network of sales companies, Sartorius Stedim Biotech has a global reach. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions of complementary technologies. In 2021, the company employed more than 10,400 people, and earned sales revenue of around 2.89 billion euros.