Barclays on U.S. Diagnostics: FDA Issues draft guidance on companion diagnostics; Positive read for QGEN
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Price: $44.07 -1.85%
Rating Summary:
14 Buy, 17 Hold, 3 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 8 | Down: 6 | New: 26
Rating Summary:
14 Buy, 17 Hold, 3 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 8 | Down: 6 | New: 26
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Barclays on U.S. Diagnostics: FDA Issues Draft Guidance on Companion Diagnostics; Positive Read for QGEN
Barclays analyst says, "Yesterday, the FDA issued draft guidance on its policy for reviewing companion diagnostics and the corresponding therapy. The document is aimed at both drug developers and diagnostic companies, and is open for comment over the next 60 days. The guidance comes out strongly in favor of greater FDA oversight of companion diagnostic devices, and concurrent approval of therapeutic products and the diagnostic tests indicated for use in guiding those therapies (e.g. patient selection, dosage)."
"Qiagen (Nasdaq: QGEN) best positioned to benefit, in our view, with a well-articulated personalized healthcare strategy: The company has a strong pipeline of markers lined up for US regulatory submission over the next several years, beginning with KRAS this year (in conjunction with EGFR inhibitors erbitux and vectibix for colorectal cancer treatment), followed by EGFR (in conjunction with Boehringer Ingelheim's afatinib), BRAF, etc."
"The strong portfolio of (>15) biopharma partnerships that the company has put in place is a significant competitive advantage. Partners include the likes of Amgen (Nasdaq: AMZN), AstraZeneca (NYSE: AZN), Eli Lilly (NYSE: LLY) and Bristol Myers (NYSE: BMY), with deals spanning disease areas like oncology, autoimmune diseases, etc. As the number of drugs coming to market with associated companion diagnostics increases, the risk of expensive delays in drug approval due to failure in getting the associated diagnostic test approved is likely to drive biopharma companies to rely heavily on established providers like Qiagen. Strong in-house regulatory and assay development expertise, proprietary platforms, and a global footprint are key differentiators."
Barclays analyst says, "Yesterday, the FDA issued draft guidance on its policy for reviewing companion diagnostics and the corresponding therapy. The document is aimed at both drug developers and diagnostic companies, and is open for comment over the next 60 days. The guidance comes out strongly in favor of greater FDA oversight of companion diagnostic devices, and concurrent approval of therapeutic products and the diagnostic tests indicated for use in guiding those therapies (e.g. patient selection, dosage)."
"Qiagen (Nasdaq: QGEN) best positioned to benefit, in our view, with a well-articulated personalized healthcare strategy: The company has a strong pipeline of markers lined up for US regulatory submission over the next several years, beginning with KRAS this year (in conjunction with EGFR inhibitors erbitux and vectibix for colorectal cancer treatment), followed by EGFR (in conjunction with Boehringer Ingelheim's afatinib), BRAF, etc."
"The strong portfolio of (>15) biopharma partnerships that the company has put in place is a significant competitive advantage. Partners include the likes of Amgen (Nasdaq: AMZN), AstraZeneca (NYSE: AZN), Eli Lilly (NYSE: LLY) and Bristol Myers (NYSE: BMY), with deals spanning disease areas like oncology, autoimmune diseases, etc. As the number of drugs coming to market with associated companion diagnostics increases, the risk of expensive delays in drug approval due to failure in getting the associated diagnostic test approved is likely to drive biopharma companies to rely heavily on established providers like Qiagen. Strong in-house regulatory and assay development expertise, proprietary platforms, and a global footprint are key differentiators."
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