We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Thermo Fisher's (TMO) Oncomine Dx Gets CDx Approval for EXKIVITY
Read MoreHide Full Article
Thermo Fisher Scientific Inc. (TMO - Free Report) recently gained pre-market approval from the FDA for its Oncomine Dx Target Test as a companion diagnostic (CDx) to detect patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC), who are eligible of becoming candidates for EXKIVITY (mobocertinib). The EXKIVITY, developed by Takeda Pharmaceutical Company Limited (“Takeda”), is a small-molecule tyrosine kinase inhibitor (TKI) developed to selectively target EGFR Exon20 insertion mutations.
Per Thermo Fisher’s management, the recent FDA authorization of the Oncomine Dx Target Test as a CDx for EXKIVITY will enable clinicians to detect key biomarkers in patients who can potentially benefit from this targeted therapy.
This authorization is likely to bolster Thermo Fisher’s CDx solutions for oncology to advance precision medicine.
More About EXKIVITY
In September 2021, the FDA approved EXKIVITY for the treatment of adult patients who have locally advanced or metastatic NSCLC with EGFR Exon20 insertion mutations as identified by an FDA-approved test and whose disease has progressed on or after platinum-based chemotherapy.
Image Source: Zacks Investment Research
This indication is approved under Accelerated Approval on the basis of an overall response rate and duration of response demonstrated in the platinum-pretreated population of the Phase 1/2 trial of EXKIVITY. In fact, continued approval for this indication could depend on the verification and description of clinical benefit in a confirmatory trial.
More on the News
Traditional polymerase chain reaction (PCR) methods can miss up to 50% of EGFR Exon20 insertion mutations. In this regard, diagnostic molecular testing using next-generation sequencing (NGS) technology becomes pertinent for early identification and proper characterization of tested patients. Notably, the Oncomine Dx Target Test is a NGS-based test, which can evaluate 23 genes associated with NSCLC at the same time.
The Oncomine Dx Target Test was initially authorized as a CDx by the FDA in 2017. At present, this test is authorized for five targeted therapies for NSCLC and one targeted therapy for cholangiocarcinoma in the United States. Presently, government and commercial insurers in more than 15 countries, including the United States, several European nations, Japan, South Korea and the Middle East, have approved and reimbursed the test.
Industry Prospects
Per a report published in Grand View Research, the global oncology companion diagnostic market is expected to see a CAGR of 12.7% from 2020 to 2027. Factors such as changing role of oncology CDx in the era of next-generation omics; increased adoption of oncology CDx assays by pharmaceutical manufacturers owing to their economic benefits as well as their ability to reduce clinical trial timelines; and enhanced drug and diagnostics co-development models post the issuance of the FDA’s “In Vitro Companion Diagnostic Devices” guidance in 2016 are fueling market growth.
Given the substantial market prospects, the recent FDA authorization of the Oncomine Dx Target Test as a CDx for EXKIVITY seems strategic.
Notable Developments
Thermo Fisher has been engaging in a number of significant developments this month.
The company’s Oncomine Dx Target Test received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) as a NGS-based CDx intended for patients with RET-fusion positive non-small-cell lung cancer (NSCLC), who are eligible for treatment with Eli Lilly and Company's (LLY - Free Report) selpercatinib (formerly known as LOXO-292). The Oncomine Dx Target Test has been approved in Japan as a CDx for five biomarkers with a total of 10 associated targeted therapies for NSCLC patients.
Thermo Fisher’s clinical sequencing business and AstraZeneca have collaborated to co-develop NGS-based CDx to support AstraZeneca's expanding portfolio of targeted therapies. The companies collaborated under a multi-year global agreement to accelerate the development and introduction of targeted precision medicine therapies.
Share Price Performance
The stock has outperformed its industry over the past year. It has grown 29.8% compared to the industry’s growth of 15.2%.
Zacks Rank and Key Picks
Currently, Thermo Fisher carries a Zacks Rank #3 (Hold).
Image: Bigstock
Thermo Fisher's (TMO) Oncomine Dx Gets CDx Approval for EXKIVITY
Thermo Fisher Scientific Inc. (TMO - Free Report) recently gained pre-market approval from the FDA for its Oncomine Dx Target Test as a companion diagnostic (CDx) to detect patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC), who are eligible of becoming candidates for EXKIVITY (mobocertinib). The EXKIVITY, developed by Takeda Pharmaceutical Company Limited (“Takeda”), is a small-molecule tyrosine kinase inhibitor (TKI) developed to selectively target EGFR Exon20 insertion mutations.
Per Thermo Fisher’s management, the recent FDA authorization of the Oncomine Dx Target Test as a CDx for EXKIVITY will enable clinicians to detect key biomarkers in patients who can potentially benefit from this targeted therapy.
This authorization is likely to bolster Thermo Fisher’s CDx solutions for oncology to advance precision medicine.
More About EXKIVITY
In September 2021, the FDA approved EXKIVITY for the treatment of adult patients who have locally advanced or metastatic NSCLC with EGFR Exon20 insertion mutations as identified by an FDA-approved test and whose disease has progressed on or after platinum-based chemotherapy.
Image Source: Zacks Investment Research
This indication is approved under Accelerated Approval on the basis of an overall response rate and duration of response demonstrated in the platinum-pretreated population of the Phase 1/2 trial of EXKIVITY. In fact, continued approval for this indication could depend on the verification and description of clinical benefit in a confirmatory trial.
More on the News
Traditional polymerase chain reaction (PCR) methods can miss up to 50% of EGFR Exon20 insertion mutations. In this regard, diagnostic molecular testing using next-generation sequencing (NGS) technology becomes pertinent for early identification and proper characterization of tested patients. Notably, the Oncomine Dx Target Test is a NGS-based test, which can evaluate 23 genes associated with NSCLC at the same time.
The Oncomine Dx Target Test was initially authorized as a CDx by the FDA in 2017. At present, this test is authorized for five targeted therapies for NSCLC and one targeted therapy for cholangiocarcinoma in the United States. Presently, government and commercial insurers in more than 15 countries, including the United States, several European nations, Japan, South Korea and the Middle East, have approved and reimbursed the test.
Industry Prospects
Per a report published in Grand View Research, the global oncology companion diagnostic market is expected to see a CAGR of 12.7% from 2020 to 2027. Factors such as changing role of oncology CDx in the era of next-generation omics; increased adoption of oncology CDx assays by pharmaceutical manufacturers owing to their economic benefits as well as their ability to reduce clinical trial timelines; and enhanced drug and diagnostics co-development models post the issuance of the FDA’s “In Vitro Companion Diagnostic Devices” guidance in 2016 are fueling market growth.
Given the substantial market prospects, the recent FDA authorization of the Oncomine Dx Target Test as a CDx for EXKIVITY seems strategic.
Notable Developments
Thermo Fisher has been engaging in a number of significant developments this month.
The company’s Oncomine Dx Target Test received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) as a NGS-based CDx intended for patients with RET-fusion positive non-small-cell lung cancer (NSCLC), who are eligible for treatment with Eli Lilly and Company's (LLY - Free Report) selpercatinib (formerly known as LOXO-292). The Oncomine Dx Target Test has been approved in Japan as a CDx for five biomarkers with a total of 10 associated targeted therapies for NSCLC patients.
Thermo Fisher’s clinical sequencing business and AstraZeneca have collaborated to co-develop NGS-based CDx to support AstraZeneca's expanding portfolio of targeted therapies. The companies collaborated under a multi-year global agreement to accelerate the development and introduction of targeted precision medicine therapies.
Share Price Performance
The stock has outperformed its industry over the past year. It has grown 29.8% compared to the industry’s growth of 15.2%.
Zacks Rank and Key Picks
Currently, Thermo Fisher carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the Medical-Instruments industry include Semler Scientific Inc. and IDEXX Laboratories, Inc. (IDXX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Semler Scientific has a long-term earnings growth rate of 25%.
IDEXX has a long-term earnings growth rate of 19.9%.