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College of American Pathologists, cap.org

EMQN, European Molecular Genetics Quality Network, emqn.org



New Test Available: FOLR1 Immunohistochemistry
The Ventana FOLR1 (FOLR1-2.1) RxDx assay is an FDA approved companion diagnostic test to detect the expression of folate receptor 1 on patients’ formalin fixed, paraffin embedded specimens of epithelial ovarian, fallopian tube, or primary peritoneal cancers, for selection of patients who are eligible for treatment with the antibody-drug conjugate mirvetuximab soravtansine-gynx (ELAHERE), who are resistant to platinum-based therapy.

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant

Specimen requirements: FFPE tissue unstained sections on coated slides (4µm)
Turnaround time: 5 working days from day of specimen received
 
KRAS G12C-AN EMERGING BIOMARKER AND NOVEL INVESTIGATIONAL TARGET IN NON-SMALL CELL LUNG CANCER
 
HKMPDC SARS-CoV-2 RT-PCR is HOKLAS accredited according to ISO15189:2012 Standards.
The ILAC MRA acts as an internationally recognised ‘stamp of approval’ to demonstrate compliance against agreed standards and requirements. The MRA also provides additional confidence to the general public and consumers purchasing our testing services.

HKMPDC SARS-CoV-2 (COVID-19) Real-time RT-PCR Assay received CE-IVD marking
according to the European Standards: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

 
HKMPDC is offering COVID-19 (2019-nCoV) real-time RT-PCR test using CE-IVD approved assay.
 
HKMPDC to provide PIK3CA hotspot mutation test for the first FDA approved treatment Piqray (alpelisib) for patient with PIK3CA mutation in HR+/HER2 advanced breast cancer using either tissue or blood sample.
FDA approves Novartis Piqray® - the first and only treatment specifically for patients with a PIK3CA mutation in HR+/HER2- advanced breast cancer
 
The First US FDA Approved Non-invasive (BLOOD) EGFR Mutation Test for Lung Cancer Targeted Therapy Using Liquid Biopsy
HKMPDC the first ISO 15189 accredited Molecular Diagnostic Laboratory to provide FDA approved liquid biopsy EGFR test.

FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
 
HKMPDC The First HOKLAS ISO 15189:2012 Accredited Laboratory for Molecular Oncology Testing.
ISO 15189 Accredited Hereditary Cancer Genetic Test:
ISO 15189 Accredited Cancer Biomarker Testing for Precision Medicine (Targeted Therapy):
More>>


FoundationOne test, Foundation Medicine