THxID®-BRAF Press Release
Hematogenix Laboratory Services to Offer FDA Approved THxID®‐BRAF Companion Diagnostic Testing Services in the US
Hematogenix® is among the first CLIA (Clinical Laboratory Improvement Amendments) facilities to offer the test to detect two BRAF mutations, V600E and V600K.
Tinley Park, IL, February 7, 2014. Hematogenix Laboratory Services (Hematogenix), a leader in the field of integrated pathology services for drug development and clinical clients, today announced the availability of the bioMérieux THxID®‐BRAF companion diagnostic test. This service will be available through both its Pharma Services and Diagnostic Services arms.
“We are delighted to introduce this valuable test in the United States” said Dr. Hytham Al‐Masri, CEO and President of Hematogenix.” The laboratory has validated this test which may aid oncologists to select patients who may benefit from BRAF directed and MEK‐directed companion therapy.”
Hematogenix will also continue to offer this test for use in clinical trials. “We were privileged to participate in the clinical development of this test and look forward to making it available for patient selection in the United States” said Patty James, Executive Director at Hematogenix. “Hematogenix will provide results within 3‐4 business days upon receipt of the specimen.”
Hematogenix scientists have gained valuable experience with this test over several thousand specimens. THxID®‐BRAF is a real‐time PCR test that offers clinicians a standardized, reproducible and clinically validated method to select patients with BRAF‐mutant unresectable or metastatic melanoma
The THxID®‐BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin‐fixed paraffin‐embedded (FFPE) human melanoma tissue. The THxID®‐BRAF kit is a real‐time PCR test on the Applied BioSystems 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib (Tafinlar®) and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib (Mekinist™).
Hematogenix is a CAP, CLIA (Clinical Laboratory Improvement Amendments) certified laboratory with a full complement of board certified clinical, anatomic and research pathologists to provide consultation and guidance for each Pharma project. The company offers a comprehensive array of biomarker development and testing services designed to navigate the complexities of human subject clinical trials.
Hematogenix provides logistic management of tissue and sample procurement, distributes collection kits and contributes to standards and procedures required for initiating a clinical trial. Powered by a state‐of‐the‐art laboratory information system, Hematogenix facilities and practices comply with rigorous chain of custody and specimen management practices.
Patty James - Executive Director