70% of today’s medical decisions depend on laboratory test results, showing the important role of clinical laboratories in today’s healthcare system. More than 14$ billion tests are ordered annually to maintain effective diagnosis and treatment. However, newer lab tests driven by technology are entering the market with FDA’s approval.
Foundation Medicine, Tempus Labs, Siemens Healthcare, Ventana Medical, and Guardant Health laboratory test devices got a nod from the FDA.
Foundation Medicine Inc. received FDA’s approval for two of its Lab tests. FoundationOne Liquid CDx (F1 Liquid CDx) helps identify people who may be eligible to receive treatment with BRAFTOVI (encorafenib) in combination with cetuximab for their metastatic colorectal cancer. Secondly, FoundationOne Liquid CDx (F1 Liquid CDx) laboratory tests help doctors identify patients with non-small cell lung cancer who may be eligible to receive treatment with EXKIVITY (mobocertinib) based on their test results.
xT CDx by Tempus Labs is a laboratory test designed to detect the presence of multiple changes in the genetic material (mutations in 648 different genes) in a person previously diagnosed with solid malignant tumors which determines if a person is eligible for treatment with ERBITUX (cetuximab) or VECTIBIX (panitumumab).
ADVIA Centaur XP/XPT HBc Total 2 by Siemens Healthcare Diagnostics tests for antibodies to a viral protein within the hepatitis B virus, also known as the core antigen (HBc). Knowing the HBV infection status will help the healthcare provider determine if the patient needs additional testing and/or should be considered for treatment.
VENTANA PD-L1 (SP263) Assay is a laboratory test designed to detect PD-L1 protein in people diagnosed with non-small cell lung cancer. Test results from the VENTANA PD-L1 (SP263) Assay are used to help doctors decide if patients with non-small cell lung cancer can receive treatment with the drug LIBTAYO (cemiplimab-rwlc).
Guardant360 CDx by Guardant Health Inc, is a lab test designed to detect gene mutations found in circulating cell-free DNA (cfDNA). This means people with breast cancer can be identified along with prognosis of FDA approved procedures. The approval expands the indications for use of the Guardant360 CDx to include the detection of ESR1 missense mutations between codons 310 and 547 in patients with breast cancer. Identifying ESR1 missense mutations between codons 310 and 547 will help people with breast cancer get personalized treatment with ORSERDU (elacestrant).
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