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QIAGEN (QGEN), Denovo to Develop CDx Test for Lymphoid Cancer
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QIAGEN N.V. (QGEN - Free Report) announced a collaboration with Denovo Biopharma to develop a companion diagnostic (CDx) test for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL) — one of the most common lymphoid cancers. Both companies seek the FDA premarket approval (PMA) of the companion diagnostic test in conjunction with the new drug application (NDA) approval.
For investors' note, Denovo Biopharma is a clinical-stage biopharmaceutical company, which utilizes novel biomarker approaches to re-evaluate medicines that have failed in wide-ranging patient populations. The company focuses on finding out genomic biomarkers correlated with patients' responses to drug candidates retrospectively.
The recent development is likely to bolster QIAGEN's oncology and precision diagnostics business.
More on the Collaboration
Per terms of the agreement, QIAGEN will develop a diagnostic assay that can identify the Denovo Genomic Marker 1 (DGM1) in DLBCL patients — a biomarker discovered by Denovo that project the responsiveness to DB102.
QIAGEN noted that it would develop a real-time qualitative PCR companion diagnostic for the QIAGEN Rotor-Gene Q MDx instrument and apply for PMA with the FDA. At present, the drug and the DGM1 marker are in a phase-III trial, known as ENGINE, on newly diagnosed, high-risk DLBCL patients.
Significance of the New Test
QIAGEN's blood-based test can help detect patients with DLBCL who are likely to respond to Denovo's new investigational cancer treatment DB102.
Image Source: Zacks Investment Research
Per QIAGEN's management, the company's molecular testing experience will help Denovo Biopharma develop the use of the DGM1 marker with the DB102 drug for patients with DLBCL.
Industry Prospects
Per a report by Fortune Business Insights, the global lymphoma treatment market size was $6.94 billion in 2018 and is projected to reach $13.11 billion by 2026, witnessing a CAGR of 8.3%.
Growing awareness about early diagnosis of lymphoma among healthcare professionals and patients, and rising government funding for research and development are driving the market. Hence, the collaboration is well-timed for QIAGEN.
Recent Developments
This month, QIAGEN announced the receipt of CE marking of its QuantiFERON SARS-CoV-2 assay, which measures T-cell responses to SARS-CoV-2 and helps evaluate immunity in individuals receiving COVID-19 vaccination. The QuantiFERON SARS-CoV-2 assay is based on QIAGEN's QuantiFERON interferon gamma release technology, which is globally recognized as an easy-to-use T-cell assay that utilizes whole blood.
In November, QIAGEN and DiaSorin announced the receipt of FDA approval of the LIAISON QuantiFERON-TB Gold Plus assay for use on DiaSorin's automated LIAISON XS platform. QIAGEN and DiaSorin developed the LIAISON QuantiFERON-TB Gold Plus, an interferon-gamma release assay (IGRA), to provide streamlined laboratory automation for latent tuberculosis (TB) screening.
Price Performance
Shares of the company have gained 4.5% in a year against the industry's decline of 23.8%.
Thermo Fisher, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.
Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.
LabCorp, carrying a Zacks Rank #2, reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%.
LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.
Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%.
Medpace has an estimated long-term growth rate of 16.4%. MEDP surpassed estimates in the trailing four quarters, the average surprise being 11.9%. It currently sports a Zacks Rank #1.
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QIAGEN (QGEN), Denovo to Develop CDx Test for Lymphoid Cancer
QIAGEN N.V. (QGEN - Free Report) announced a collaboration with Denovo Biopharma to develop a companion diagnostic (CDx) test for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL) — one of the most common lymphoid cancers. Both companies seek the FDA premarket approval (PMA) of the companion diagnostic test in conjunction with the new drug application (NDA) approval.
For investors' note, Denovo Biopharma is a clinical-stage biopharmaceutical company, which utilizes novel biomarker approaches to re-evaluate medicines that have failed in wide-ranging patient populations. The company focuses on finding out genomic biomarkers correlated with patients' responses to drug candidates retrospectively.
The recent development is likely to bolster QIAGEN's oncology and precision diagnostics business.
More on the Collaboration
Per terms of the agreement, QIAGEN will develop a diagnostic assay that can identify the Denovo Genomic Marker 1 (DGM1) in DLBCL patients — a biomarker discovered by Denovo that project the responsiveness to DB102.
QIAGEN noted that it would develop a real-time qualitative PCR companion diagnostic for the QIAGEN Rotor-Gene Q MDx instrument and apply for PMA with the FDA. At present, the drug and the DGM1 marker are in a phase-III trial, known as ENGINE, on newly diagnosed, high-risk DLBCL patients.
Significance of the New Test
QIAGEN's blood-based test can help detect patients with DLBCL who are likely to respond to Denovo's new investigational cancer treatment DB102.
Per QIAGEN's management, the company's molecular testing experience will help Denovo Biopharma develop the use of the DGM1 marker with the DB102 drug for patients with DLBCL.
Industry Prospects
Per a report by Fortune Business Insights, the global lymphoma treatment market size was $6.94 billion in 2018 and is projected to reach $13.11 billion by 2026, witnessing a CAGR of 8.3%.
Growing awareness about early diagnosis of lymphoma among healthcare professionals and patients, and rising government funding for research and development are driving the market. Hence, the collaboration is well-timed for QIAGEN.
Recent Developments
This month, QIAGEN announced the receipt of CE marking of its QuantiFERON SARS-CoV-2 assay, which measures T-cell responses to SARS-CoV-2 and helps evaluate immunity in individuals receiving COVID-19 vaccination. The QuantiFERON SARS-CoV-2 assay is based on QIAGEN's QuantiFERON interferon gamma release technology, which is globally recognized as an easy-to-use T-cell assay that utilizes whole blood.
In November, QIAGEN and DiaSorin announced the receipt of FDA approval of the LIAISON QuantiFERON-TB Gold Plus assay for use on DiaSorin's automated LIAISON XS platform. QIAGEN and DiaSorin developed the LIAISON QuantiFERON-TB Gold Plus, an interferon-gamma release assay (IGRA), to provide streamlined laboratory automation for latent tuberculosis (TB) screening.
Price Performance
Shares of the company have gained 4.5% in a year against the industry's decline of 23.8%.
Zacks Rank and Key Picks
QIAGEN currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the broader medical space are Thermo Fisher Scientific Inc. (TMO - Free Report) , Laboratory Corporation of America Holdings (LH - Free Report) , or LabCorp and Medpace Holdings, Inc. (MEDP - Free Report) . You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Thermo Fisher, currently carrying a Zacks Rank #2 (Buy), reported third-quarter 2021 adjusted earnings per share (EPS) of $5.76, which surpassed the Zacks Consensus Estimate by 23.3%. Revenues of $9.33 billion outpaced the Zacks Consensus Estimate by 12%.
Thermo Fisher has an estimated long-term growth rate of 14%. TMO surpassed estimates in the trailing four quarters, the average surprise being 9.02%.
LabCorp, carrying a Zacks Rank #2, reported third-quarter 2021 adjusted EPS of $6.82, which surpassed the Zacks Consensus Estimate by 42.9%. Revenues of $4.06 billion outpaced the Zacks Consensus Estimate by 13.4%.
LabCorp has an estimated long-term growth rate of 10.6%. LH surpassed estimates in the trailing four quarters, the average surprise being 25.7%.
Medpace reported third-quarter 2021 adjusted EPS of $1.29, surpassing the Zacks Consensus Estimate by 20.6%. Revenues of $295.57 million beat the Zacks Consensus Estimate by 1.2%.
Medpace has an estimated long-term growth rate of 16.4%. MEDP surpassed estimates in the trailing four quarters, the average surprise being 11.9%. It currently sports a Zacks Rank #1.