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QIAGEN Launches Assay for Cancer Patients Following FDA's Nod
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QIAGEN N.V. (QGEN - Free Report) announces the receipt of the FDA’s approval for its therascreen BRAF V600E RGQ polymerase chain reaction (“PCR”) Kit (therascreen BRAF V600E) as a companion diagnostic to the BRAF inhibitor, BRAFTOVI (encorafenib). The company also announced the subsequent launch of the kit. The FDA approved the use of the PCR kit as a companion diagnostic in combination with cetuximab to treat adult patients, who have metastatic colorectal cancer (“CRC”), with a BRAF V600E mutation after prior therapy. Notably, CRC patients having the mutation will be identified, using an FDA-approved test.
The therascreen BRAF V600E assay runs on QIAGEN’s Rotor-Gene Q MDx, which belongs to the modular QIAsymphony family of automation solutions.
Notably, the regulatory approval of the therascreen BRAF V600E is the 8th one for a treatment with QIAGEN’s companion diagnostic assay. Per the company, the BRAF V600E is its first companion diagnostic test to receive the FDA clearance for detecting mutation in the BRAF gene. Further, it is its third CDx approval in CRC.
With the recent launch, QIAGEN aims to strengthen foothold in the global Precision Medicine market.
Significance of the Launch
Per current statistics, CRC is the third most common-occurring cancer, affecting more than 150,000 people a year in the United States alone. In patients with primary and metastatic CRC, BRAF mutations (mostly V600E) are present in up to 15% of patients. Further, the mutations are thought to be the primary tumor growth drivers. Given the scenario, detection of the mutation with the therascreen BRAF V600E kit will enable to identify eligible candidates to receive the approved treatment combination of BRAFTOVI and cetuximab.
Per the company, the latest test will enable the medical fraternity to take proper treatment decisions for CRC, thereby addressing the huge unmet medical needs of patients.
Industry Prospects
Per a report by Global Market Insights, the precision medicine market size was more than $57 billion in 2019 and is expected to exceed $119 billion by 2026, witnessing a CAGR of more than 11% between 2020 and 2026. Factors like rising prevalence of cancer and significant advancements in the field of gene therapy are expected to drive the market.
Given the market potential, the launch of the kit is well-timed.
Recent Developments in Precision Medicine
Of late, QIAGEN has witnessed a series of developments, with respect to its precision medicine segment.
In February, the company launched the therascreen PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation, following the receipt of the CE mark. The therascreen PIK3CA test was approved by the FDA in 2018 and subsequently launched as a companion diagnostic test for Piqray (alpelisib) in the United States.
In January, QIAGEN entered a collaboration with Amgen to develop tissue-based companion diagnostics for Amgen’s investigational cancer treatment, AMG 510. The aim of the collaboration was to identify cancer patients, who have the KRAS G12C mutation.
Share Price Movement
QIAGEN has outperformed its industry over the past year. The stock has risen 4.9% compared with 2.2% growth of the industry and against a 4.1% fall of the S&P 500.
Zacks Rank & Stocks to Consider
The company currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the broader medical space are ResMed Inc. (RMD - Free Report) , National Vision Holdings, Inc. (EYE - Free Report) and Phibro Animal Health Corporation (PAHC - Free Report) .
National Vision’s long-term earnings growth rate is estimated at 10.7%. The company presently has a Zacks Rank #2.
Phibro’s long-term earnings growth rate is estimated at 2.1%. It currently carries a Zacks Rank #2.
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Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Image: Bigstock
QIAGEN Launches Assay for Cancer Patients Following FDA's Nod
QIAGEN N.V. (QGEN - Free Report) announces the receipt of the FDA’s approval for its therascreen BRAF V600E RGQ polymerase chain reaction (“PCR”) Kit (therascreen BRAF V600E) as a companion diagnostic to the BRAF inhibitor, BRAFTOVI (encorafenib). The company also announced the subsequent launch of the kit. The FDA approved the use of the PCR kit as a companion diagnostic in combination with cetuximab to treat adult patients, who have metastatic colorectal cancer (“CRC”), with a BRAF V600E mutation after prior therapy. Notably, CRC patients having the mutation will be identified, using an FDA-approved test.
The therascreen BRAF V600E assay runs on QIAGEN’s Rotor-Gene Q MDx, which belongs to the modular QIAsymphony family of automation solutions.
Notably, the regulatory approval of the therascreen BRAF V600E is the 8th one for a treatment with QIAGEN’s companion diagnostic assay. Per the company, the BRAF V600E is its first companion diagnostic test to receive the FDA clearance for detecting mutation in the BRAF gene. Further, it is its third CDx approval in CRC.
With the recent launch, QIAGEN aims to strengthen foothold in the global Precision Medicine market.
Significance of the Launch
Per current statistics, CRC is the third most common-occurring cancer, affecting more than 150,000 people a year in the United States alone. In patients with primary and metastatic CRC, BRAF mutations (mostly V600E) are present in up to 15% of patients. Further, the mutations are thought to be the primary tumor growth drivers. Given the scenario, detection of the mutation with the therascreen BRAF V600E kit will enable to identify eligible candidates to receive the approved treatment combination of BRAFTOVI and cetuximab.
Per the company, the latest test will enable the medical fraternity to take proper treatment decisions for CRC, thereby addressing the huge unmet medical needs of patients.
Industry Prospects
Per a report by Global Market Insights, the precision medicine market size was more than $57 billion in 2019 and is expected to exceed $119 billion by 2026, witnessing a CAGR of more than 11% between 2020 and 2026. Factors like rising prevalence of cancer and significant advancements in the field of gene therapy are expected to drive the market.
Given the market potential, the launch of the kit is well-timed.
Recent Developments in Precision Medicine
Of late, QIAGEN has witnessed a series of developments, with respect to its precision medicine segment.
In February, the company launched the therascreen PIK3CA RGQ PCR Kit in Europe as an aid in identifying breast cancer patients with a PIK3CA mutation, following the receipt of the CE mark. The therascreen PIK3CA test was approved by the FDA in 2018 and subsequently launched as a companion diagnostic test for Piqray (alpelisib) in the United States.
In January, QIAGEN entered a collaboration with Amgen to develop tissue-based companion diagnostics for Amgen’s investigational cancer treatment, AMG 510. The aim of the collaboration was to identify cancer patients, who have the KRAS G12C mutation.
Share Price Movement
QIAGEN has outperformed its industry over the past year. The stock has risen 4.9% compared with 2.2% growth of the industry and against a 4.1% fall of the S&P 500.
Zacks Rank & Stocks to Consider
The company currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the broader medical space are ResMed Inc. (RMD - Free Report) , National Vision Holdings, Inc. (EYE - Free Report) and Phibro Animal Health Corporation (PAHC - Free Report) .
ResMed has a projected long-term earnings growth rate of 14.4%. It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
National Vision’s long-term earnings growth rate is estimated at 10.7%. The company presently has a Zacks Rank #2.
Phibro’s long-term earnings growth rate is estimated at 2.1%. It currently carries a Zacks Rank #2.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>