Feb 04 2020
Manchester, UK, 4th February 2020: EMQN CIC (“EMQN” or “the Company”), a global leader in external quality assessment (EQA) / proficiency testing (PT) for genomics, today announced it is launching a pilot EQA scheme for PIK3CA testing in patients with advanced or metastatic breast cancer.
On 24 May 2019, the US Food and Drug Administration (FDA) approved alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
At the same time, the FDA also approved the companion diagnostic test, therascreen® PIK3CA RGQ PCR Kit, (QIAGEN Manchester, Ltd.), to select patients who have PIK3CA mutations in tumour tissue specimens and/or in circulating tumour DNA (ctDNA) isolated from plasma specimens. This test is now also available outside the USA as a CE-IVD Kit (www.qiagen.com/PIK3CA-CE).
Global testing for PIK3CA mutations in advanced or metastatic breast cancer is expected to increase over the next 12 months and quality assurance of this activity is essential to ensure testing accuracy and appropriate prescription of alpelisib. EMQN has launched a pilot EQA scheme that will complement the QIAGEN companion diagnostic test. The scheme will initially provide EQA materials for solid tumour testing but subsequent rounds will also incorporate assessment of laboratories testing ctDNA in plasma. The scheme will work for all labs, irrespective of whether they are using NGS based testing, or a targeted test (for example the therascreen® PIK3CA RGQ PCR Kit).
Simon Patton, Managing Director, EMQN, said: “this new pilot EQA scheme will complement our existing quality assurance activities in breast and ovarian cancer testing, and further strengthen EMQN’s position as a global provider of EQA to genomics laboratories”.
Laboratories that wish to participate in the pilot EQA are invited to complete an expression of interest by the 1st April 2020.
The application form can be accessed via the EMQN website (PIK3CA APPLICATION FORM).
About EMQN CIC: EMQN CIC, a community interest company (CIC) registered in England and Wales, is a provider of external quality assessment / proficiency testing services to more than 2500 customers in 79 different countries. Our EQA services enable laboratories and manufacturers to assess the performance of their clinical diagnostic tests. These types of activities are a mandatory component of laboratory accreditation to ISO 15189 and provide an independent external audit of laboratory process including test validation / verification, as well offering the opportunity for commercial kit manufacturers to undertake post market surveillance of performance (addressing some of the needs of the EU In Vitro Diagnostic Regulation (IVDR). EMQN CIC is accredited by the United Kingdom Accreditation Service (UKAS) to the ISO 17043 standard. Our registered address is C/O Trustech, Citylabs 1.0, Nelson Street, Manchester, M13 9NQ, United Kingdom. Further information can be found at http://www.emqn.org.