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Thermo Fisher's (TMO) Oncomine Dx Gets CDx Approval for TIBSOVO
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Thermo Fisher Scientific Inc. (TMO - Free Report) gained pre-market approval from the FDA for its Oncomine Dx Target Test as a companion diagnostic (CDx) for Servier Pharmaceuticals' TIBSOVO (ivosidenib tablets). With the approval, the CDx will be used for the identification of patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA), who are potential candidates for TIBSOVO, an IDH1 inhibitor.
TIBSOVO is authorized for the treatment of adult patients with previously treated, locally advanced or metastatic CCA with an IDH1 mutation as detected by an FDA-approved test.
The Oncomine Dx Target Test is based on the next-generation sequencing (NGS) technology. It delivers robust and reproducible results in the IDH1 gene clinically associated with CCA. The NGS-based test was initially approved as a CDx by the FDA in 2017. At present, it is approved for four targeted therapies for non-small-cell lung cancer and one targeted therapy for CCA in the United States.
Per management, the FDA authorization for the Oncomine Dx Target Test as a companion diagnostic for TIBSOVO will enable healthcare providers to match patients with the critically needed therapy in the United States.
A Few Words on TIBSOVO
The approval of TIBSOVO in previously treated IDH1-mutated CCA is supported by data from the ClarIDHy study. Per Servier management, the FDA approval of TIBSOVO marks a milestone for the cholangiocarcinoma community, as prior to the approval, there was no approved targeted therapy treatment option available for patients with IDH1-mutated cholangiocarcinoma.
Image Source: Zacks Investment Research
Notably, TIBSOVO is also authorized as monotherapy in the United States. The treatment is indicated for adults with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutated AML, who are aged between 75 years and older, or those who have comorbidities that preclude the use of intensive induction chemotherapy.
More in the News
Thermo Fisher also inked a deal with Servier to develop and commercialize a CDx, leveraging the Oncomine Precision Assay, to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations, who may be eligible for vorasidenib (AG-881). The Oncomine Precision Assay runs on the Ion Torrent Genexus System. However, both Oncomine Precision Assay and Torrent Genexus System are available for research use only and not for use in diagnostic procedures at present.
Industry Prospects
Per a report published in MarketsandMarkets, the companion diagnostics market is expected to see a CAGR of 12.9% between 2020 and 2025. Major factors such as growing demand for next-generation sequencing, the greater significance of companion diagnostics in drug development and the rising number of clinical trials are driving the companion diagnostics market’s growth.
Other factors propelling market growth include advantages of companion diagnostics, increasing need for targeted therapy, growing importance of personalized medicine, increasing incidence of cancer worldwide and the ever-increasing application areas of companion diagnostics.
Given the substantial market prospects, the FDA go-ahead for the Oncomine Dx Target Test as a companion diagnostic for TIBSOVO seems well-timed.
Notable Developments
Thermo Fisher engaged in a number of significant developments in August 2021.
The company gained emergency use authorization (EUA) from the FDA for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0. The PCR-based kits leverage an updated design from the original TaqPath assays. They are designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.
Thermo Fisher partnered with ChromSword to launch an automated high performance liquid chromatography (HPLC) and ultra-high performance liquid chromatography (UHPLC) method development system. The system addresses the challenges associated with Liquid chromatography method development, which is a time-consuming and labor-intensive process.
Share Price Performance
The stock has outperformed its industry over the past year. It has grown 30.3% compared to the industry’s growth of 14.2%.
Zacks Rank and Key Picks
Currently, Thermo Fisher carries a Zacks Rank #3 (Hold).
Image: Shutterstock
Thermo Fisher's (TMO) Oncomine Dx Gets CDx Approval for TIBSOVO
Thermo Fisher Scientific Inc. (TMO - Free Report) gained pre-market approval from the FDA for its Oncomine Dx Target Test as a companion diagnostic (CDx) for Servier Pharmaceuticals' TIBSOVO (ivosidenib tablets). With the approval, the CDx will be used for the identification of patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma (CCA), who are potential candidates for TIBSOVO, an IDH1 inhibitor.
TIBSOVO is authorized for the treatment of adult patients with previously treated, locally advanced or metastatic CCA with an IDH1 mutation as detected by an FDA-approved test.
The Oncomine Dx Target Test is based on the next-generation sequencing (NGS) technology. It delivers robust and reproducible results in the IDH1 gene clinically associated with CCA. The NGS-based test was initially approved as a CDx by the FDA in 2017. At present, it is approved for four targeted therapies for non-small-cell lung cancer and one targeted therapy for CCA in the United States.
Per management, the FDA authorization for the Oncomine Dx Target Test as a companion diagnostic for TIBSOVO will enable healthcare providers to match patients with the critically needed therapy in the United States.
A Few Words on TIBSOVO
The approval of TIBSOVO in previously treated IDH1-mutated CCA is supported by data from the ClarIDHy study. Per Servier management, the FDA approval of TIBSOVO marks a milestone for the cholangiocarcinoma community, as prior to the approval, there was no approved targeted therapy treatment option available for patients with IDH1-mutated cholangiocarcinoma.
Image Source: Zacks Investment Research
Notably, TIBSOVO is also authorized as monotherapy in the United States. The treatment is indicated for adults with IDH1-mutated relapsed or refractory acute myeloid leukemia (AML) and for adults with newly diagnosed IDH1-mutated AML, who are aged between 75 years and older, or those who have comorbidities that preclude the use of intensive induction chemotherapy.
More in the News
Thermo Fisher also inked a deal with Servier to develop and commercialize a CDx, leveraging the Oncomine Precision Assay, to identify low-grade glioma (LGG) patients with isocitrate dehydrogenase 1 and 2 (IDH1 and IDH2) mutations, who may be eligible for vorasidenib (AG-881). The Oncomine Precision Assay runs on the Ion Torrent Genexus System. However, both Oncomine Precision Assay and Torrent Genexus System are available for research use only and not for use in diagnostic procedures at present.
Industry Prospects
Per a report published in MarketsandMarkets, the companion diagnostics market is expected to see a CAGR of 12.9% between 2020 and 2025. Major factors such as growing demand for next-generation sequencing, the greater significance of companion diagnostics in drug development and the rising number of clinical trials are driving the companion diagnostics market’s growth.
Other factors propelling market growth include advantages of companion diagnostics, increasing need for targeted therapy, growing importance of personalized medicine, increasing incidence of cancer worldwide and the ever-increasing application areas of companion diagnostics.
Given the substantial market prospects, the FDA go-ahead for the Oncomine Dx Target Test as a companion diagnostic for TIBSOVO seems well-timed.
Notable Developments
Thermo Fisher engaged in a number of significant developments in August 2021.
The company gained emergency use authorization (EUA) from the FDA for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0. The PCR-based kits leverage an updated design from the original TaqPath assays. They are designed with increased target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.
Thermo Fisher partnered with ChromSword to launch an automated high performance liquid chromatography (HPLC) and ultra-high performance liquid chromatography (UHPLC) method development system. The system addresses the challenges associated with Liquid chromatography method development, which is a time-consuming and labor-intensive process.
Share Price Performance
The stock has outperformed its industry over the past year. It has grown 30.3% compared to the industry’s growth of 14.2%.
Zacks Rank and Key Picks
Currently, Thermo Fisher carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the Medical-Instruments industry are Intuitive Surgical, Inc. (ISRG - Free Report) , Semler Scientific Inc. and IDEXX Laboratories, Inc. (IDXX - Free Report) , each presently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Intuitive Surgical has a long-term earnings growth rate of 9.7%.
Semler Scientific has a long-term earnings growth rate of 25%.
IDEXX has a long-term earnings growth rate of 19.9%.