QIAGEN (QGEN) Launches PIK3CA Kit for Breast Cancer Patients

QIAGEN N.V. QGEN recently announced the launch of therascreen PIK3CA RGQ PCR Kit, also known as therascreen PIK3CA Kit, for the treatment of breast cancer. The kit has received regulatory approval from the FDA as a companion diagnostic which treats with PIQRAY (alpelisib), a therapy developed and marketed by Novartis. The launch fortifies QIAGEN’s foothold in the field of cancer diagnosis.

More on therascreen PIK3CA Kit

The therascreen PIK3CA Kit is the first companion diagnostic test to have attained premarket approval from the FDA for identification of activating mutations in the PIK3CA gene. It is also the first FDA approved test using plasma specimens as a liquid biopsy, which can enable one to make treatment decisions in breast cancer. The kit is equipped to identify 11 PIK3CA mutations, which are assumed to be present in approximately 40% of hormone receptor-positive advanced or metastatic breast cancer patients.

The real-time qualitative PCR kit is processed on QIAGEN’s Rotor-Gene Q MDx, a member of the modular QIAsymphony suite of automation solutions. The test uses QIAGEN’s global co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.

QIAGEN collaborated with Novartis to develop the therascreen PIK3CA Kit and received FDA clearance along with the pharma company’s PIQRAY.

Recent Developments

Of late, QIAGEN has been investing in some crucial developments which are expected to strengthen its foothold in the cancer diagnosis and treatment market.

Earlier this month, QIAGEN collaborated with Inovio Pharmaceuticals to co-develop a companion diagnostic which can guide clinical decision-making for the use of Inovio’s DNA-based immunotherapy to treat cervical dysplasia caused by human papillomavirus (HPV). This Precision Medicine partnership focuses on Inovio’s VGX-3100, a late-stage investigational product with possibility to become the first treatment for HPV infection of the cervix and the first non-surgical treatment for precancerous cervical lesions associated with the virus.

Last month, QIAGEN announced the U.S. launch of its novel therascreen FGFR RGQ RT-PCR Kit as a companion diagnostic which can provide guidance in the use of the recently-approved FGFR kinase inhibitor, BALVERSA, developed by Janssen Biotech. The test will enable the identification of patients with urothelial cancer whose tumors have certain alterations in the fibroblast growth factor receptor 3 gene. The FDA co-approved the new test with BALVERSA.

Market prospects

Per Grand View Research, the global cancer diagnostics is expected to see a CAGR of 7% from 2019 to 2026. Hence QIAGEN’s latest launch is a well-timed one.

Price Performance

Over the past year, QIAGEN has outperformed its industry. The stock has rallied 5.2% against the industry’s 16.4% fall.

Zacks Rank and Key Picks

QIAGEN currently carries a Zacks Rank # 3 (Hold).

Some better-ranked stocks in the broader medical space are Cerner Corporation CERN, Penumbra PEN and Bruker Corporation BRKR. While Cerner sports a Zacks Rank #1 (Strong Buy), the other two carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Cerner’s long-term earnings growth rate is expected to be 13.5%.

Penumbra’s long-term earnings growth rate is projected at 21.5%.

Bruker’s long-term earnings growth rate is estimated at 11.7%.

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