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Thermo Fisher's (TMO) CDx Gets FDA's Nod for Synovial Sarcoma
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Thermo Fisher Scientific (TMO - Free Report) recently secured FDA’s 510(k) clearance for its SeCore CDx HLA A Sequencing System for use as a companion diagnostic (CDx) alongside Adaptimmune’s newly approved T-cell receptor (TCR) therapy, TECELRA (afamitresgene autoleucel). The latter is the first engineered cell therapy for a solid tumor cancer approved in the United States and the first new therapy option in more than a decade for synovial sarcoma — a rare, soft tissue cancer that most commonly impacts young adults.
The recent development will enhance Thermo Fisher’s Transplant Diagnostics business, which is part of the Specialty Diagnostics segment.
News in Detail
TECELRA is approved for treating adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are certain HLA (human leukocyte antigen) type positive and whose tumor expresses the MAGE-A4 antigen, as determined by FDA-approved or cleared CDx devices.
Cancer immunotherapies, including TCR therapies, have become increasingly powerful tools in cancer treatment, particularly for patients with metastatic or unresectable tumors. TCRs interact with specific HLA proteins to activate an immune response, making high-resolution HLA typing a critical step in identifying patients most likely to benefit from engineered TCR T-cell therapies like TECELRA.
Image Source: Zacks Investment Research
While the origins of HLA typing are most closely associated with transplant diagnostics, a critical component of matching patients and donors to reduce the risk of immune-mediated rejection, HLA proteins have wide-reaching effects on the immune system and can potentially play a role in many immune-mediated conditions. In this regard, TMO’s Transplant Diagnostics business leverages its history of innovation in immunology to help customers develop novel treatments that enable better patient outcomes, regardless of therapeutic area.
The company is thrilled to expand the labeling of the SeCore CDx HLA A Sequencing System to include TECELRA and support clinicians in identifying which patients may benefit from this first-of-its-kind treatment. The Thermo Fisher team is focused on evolving their understanding of the human immune system and how it might impact treatment options across the healthcare continuum. Partnering with innovative companies like Adaptimmune enables it to expand patient access to breakthrough treatments that improve quality of life.
Industry Prospects
Per a Grand View Research report, the global T-Cell therapy market was valued at $2.83 billion in 2022 and is expected to witness a CAGR of 35.3% up to 2030.
With the approval of therapies like Tecartus, Yescarta and Kymriah, various companies have shifted their business model from the development of small molecule and protein-based treatments to adoptive therapies. This factor has led to increased strategic investments by private as well as public agencies in the arena, boosting market growth. Furthermore, the rise in product approval, along with increasing manufacturing capacities, is expected to boost the market competition in T-cell therapy entities in the coming years.
Recent Developments in the Specialty Diagnostics Division
Last month, Thermo Fisher introduced a new pre-transplant risk assessment assay via its CLIA laboratory in Fishers, Ind., that helps assess the risk of early acute rejection in kidney transplant recipients, providing data that may inform a more personalized approach to post-transplant immunosuppression management. The One Lambda Pre-Transplant Risk Assessment (PTRA) Assay is the first test of its kind to provide a risk score for early acute rejection based on a patient’s unique gene profile before transplant.
Additionally, the company also received the FDA’s extended 510(k) clearance to market its Optilite Freelite assays claim for the evaluation of monoclonal gammopathy of undetermined significance (MGUS). The assays previously received 510k clearance, following the FDA’s requirements, for the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE).
Price Performance
In the past year, TMO shares have rallied 10.8% compared with the industry’s rise of 5.4%.
Zacks Rank and Key Picks
Thermo Fisher currently carries a Zacks Rank #3 (Hold).
Masimo shares have risen 13.2% in the past year. Estimates for the company’s earnings have increased from $3.63 to $3.83 in 2024 and from $3.97 to $4.20 in 2025 in the past 30 days.
MASI’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 14.6%. In the last reported quarter, it posted an earnings surprise of 11.7%.
Estimates for Boston Scientific’s 2024 earnings per share have moved to $2.40 from $2.32 in the past 30 days. Shares of the company have rallied 47.9% in the past year compared with the industry’s rise of 5.6%.
BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.
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Thermo Fisher's (TMO) CDx Gets FDA's Nod for Synovial Sarcoma
Thermo Fisher Scientific (TMO - Free Report) recently secured FDA’s 510(k) clearance for its SeCore CDx HLA A Sequencing System for use as a companion diagnostic (CDx) alongside Adaptimmune’s newly approved T-cell receptor (TCR) therapy, TECELRA (afamitresgene autoleucel). The latter is the first engineered cell therapy for a solid tumor cancer approved in the United States and the first new therapy option in more than a decade for synovial sarcoma — a rare, soft tissue cancer that most commonly impacts young adults.
The recent development will enhance Thermo Fisher’s Transplant Diagnostics business, which is part of the Specialty Diagnostics segment.
News in Detail
TECELRA is approved for treating adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are certain HLA (human leukocyte antigen) type positive and whose tumor expresses the MAGE-A4 antigen, as determined by FDA-approved or cleared CDx devices.
Cancer immunotherapies, including TCR therapies, have become increasingly powerful tools in cancer treatment, particularly for patients with metastatic or unresectable tumors. TCRs interact with specific HLA proteins to activate an immune response, making high-resolution HLA typing a critical step in identifying patients most likely to benefit from engineered TCR T-cell therapies like TECELRA.
Image Source: Zacks Investment Research
While the origins of HLA typing are most closely associated with transplant diagnostics, a critical component of matching patients and donors to reduce the risk of immune-mediated rejection, HLA proteins have wide-reaching effects on the immune system and can potentially play a role in many immune-mediated conditions. In this regard, TMO’s Transplant Diagnostics business leverages its history of innovation in immunology to help customers develop novel treatments that enable better patient outcomes, regardless of therapeutic area.
The company is thrilled to expand the labeling of the SeCore CDx HLA A Sequencing System to include TECELRA and support clinicians in identifying which patients may benefit from this first-of-its-kind treatment. The Thermo Fisher team is focused on evolving their understanding of the human immune system and how it might impact treatment options across the healthcare continuum. Partnering with innovative companies like Adaptimmune enables it to expand patient access to breakthrough treatments that improve quality of life.
Industry Prospects
Per a Grand View Research report, the global T-Cell therapy market was valued at $2.83 billion in 2022 and is expected to witness a CAGR of 35.3% up to 2030.
With the approval of therapies like Tecartus, Yescarta and Kymriah, various companies have shifted their business model from the development of small molecule and protein-based treatments to adoptive therapies. This factor has led to increased strategic investments by private as well as public agencies in the arena, boosting market growth. Furthermore, the rise in product approval, along with increasing manufacturing capacities, is expected to boost the market competition in T-cell therapy entities in the coming years.
Recent Developments in the Specialty Diagnostics Division
Last month, Thermo Fisher introduced a new pre-transplant risk assessment assay via its CLIA laboratory in Fishers, Ind., that helps assess the risk of early acute rejection in kidney transplant recipients, providing data that may inform a more personalized approach to post-transplant immunosuppression management. The One Lambda Pre-Transplant Risk Assessment (PTRA) Assay is the first test of its kind to provide a risk score for early acute rejection based on a patient’s unique gene profile before transplant.
Additionally, the company also received the FDA’s extended 510(k) clearance to market its Optilite Freelite assays claim for the evaluation of monoclonal gammopathy of undetermined significance (MGUS). The assays previously received 510k clearance, following the FDA’s requirements, for the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström’s macroglobulinemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE).
Price Performance
In the past year, TMO shares have rallied 10.8% compared with the industry’s rise of 5.4%.
Zacks Rank and Key Picks
Thermo Fisher currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Masimo (MASI - Free Report) and Boston Scientific (BSX - Free Report) . While Masimo sports a Zacks Rank #1 (Strong Buy), Boston Scientific carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks Rank #1 stocks here.
Masimo shares have risen 13.2% in the past year. Estimates for the company’s earnings have increased from $3.63 to $3.83 in 2024 and from $3.97 to $4.20 in 2025 in the past 30 days.
MASI’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 14.6%. In the last reported quarter, it posted an earnings surprise of 11.7%.
Estimates for Boston Scientific’s 2024 earnings per share have moved to $2.40 from $2.32 in the past 30 days. Shares of the company have rallied 47.9% in the past year compared with the industry’s rise of 5.6%.
BSX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 7.2%. In the last reported quarter, it delivered an earnings surprise of 6.9%.