Labcorp Receives FDA Approval for First Companion Diagnostic for Use with Pfizer's Newly Approved Gene Therapy to Treat Patients with Hemophilia B [Yahoo! Finance]
Laboratory Corporation of America Holdings (LH)
Last laboratory corporation of america holdings earnings: 4/29 06:53 am
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Source: Yahoo! Finance
April 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ ™ (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA-approved hemophilia B gene therapy. The nAbCyte cell-based neutralizing antibody assay is a component of Pfizer's program to target recombinant adeno-associated virus (rAAV)-based gene therapies to the appropriate patient population. Before infusion with BEQVEZ, patients will require testing for preexisting anti-AAVRh74var antibodies. Labcorp's nAbCyte cell-based neutralizing antibody assay will allow for the accurate detection of preexisting neutralizing antibodies (nAbs), which could impact patient safety and/or efficacy of the one-time treatment. "At Labcorp, we are committed to advancing cell and gene th
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LH
Earnings
- 4/25/24 - Beat
LH
Sec Filings
- 5/16/24 - Form 4
- 5/14/24 - Form 144
- 5/8/24 - Form 8-K
- LH's page on the SEC website