11 June 2019 - - US-based life sciences company LabCorp (NYSE: LH) is offering a new companion diagnostic called therascreen PIK3CA PCR mutation analysis, which is now available through LabCorp and its Integrated Oncology specialty laboratory, the company said.
The test, developed by Qiagen (NYSE: QGEN), a provider of Sample to Insight solutions for molecular testing, identifies whether a patient has the specific gene mutation that is a prerequisite for treatment with Piqray (aplelisib), a new therapy from Novartis for the treatment of postmenopausal women and all men with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.
Piqray, in combination with fulvestrant, and therascreen PIK3CA PCR mutation analysis assay received approval from the US Food and Drug Administration on May 24, 2019.
LabCorp is able to make the test available quickly after FDA approval through its participation in Qiagen's Day-One Lab Readiness programme, under which LabCorp began test validation and development of operating protocols while the test was under regulatory review and is therefore able to make the test available to patients just two weeks after approval.
The American Cancer Society estimates that in 2019, there will be 268,600 new cases of breast cancer and approximately 70% will be HR+/HER2-.
For patients with HR+/HER2-advanced breast cancer, approximately 40% have the PIK3CA mutation, which is associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis.
The availability of this new companion diagnostic demonstrates LabCorp's continued leadership in companion diagnostics and precision medicine, with a portfolio of tests that identify personalised characteristics for each patient, and help guide more specific treatment choices.
For more than 20 years, long before they joined forces, LabCorp Diagnostics and Covance Drug Development have been involved in the development, commercialisation and launch of companion and complementary diagnostics, and together they have supported more FDA-approved companion diagnostics than any other company.
Since 2018, the company has collaborated with more than 75 clients on over 150 projects targeted at the development of new companion diagnostics.
LabCorp joined Qiagen's Day-One Lab Readiness program in early 2019. In addition to the therascreen PIK3CA PCR mutation analysis assay, LabCorp also recently launched the therascreen FGFR mutation assay by RGQ RT-PCR for bladder cancer through the Day-One program.
Multiple other assays, including novel companion diagnostics for lung, colorectal, bladder and other cancers, and eventually pan-tumor disease areas, are currently in LabCorp's Day-One Lab Readiness pipeline.
LabCorp (NYSE: LH) offers diagnostic solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care.