Despite the initial high cost, the firm believes the assay's improved accuracy and sensitivity will sway clinical and payor interest.
The company's PD-L1 IHC 28-8 pharmDx diagnostic can now be used in cases of urothelial carcinoma and squamous cell carcinoma of the head and neck.
The company announced positive coverage decisions from Palmetto GBA, 14 BCBS plans, and Aetna.
Last week's buys of two oncology labs will allow Quest to provide new cancer diagnostic technologies to communities lacking major cancer research centers, it said.
Castle will use the proceeds to accelerate marketing and new product development related to its molecular prognostic tests for patients with underserved cancers.
MultiGen said its test identified and confirmed the BRAF p.V600E mutation with a thousandfold increase in sensitivity compared to competing PCR-based and NGS methods.
Groups from Austria, Spain, Germany, and the US demonstrated that the GeneReader can reliably detect cancer mutations in tissue and liquid biopsy samples.
The company believes Indian clinicians and patients will be receptive to this new technology, but only in an efficient and actionable form.
Following validation, the approach, which uses a deep convolutional neural network trained with almost 130,000 clinical images, could be developed into a smartphone app to detect skin cancer early.
The Taiwanese research team that developed the method showed in a new study that it could better detect BRAF mutations than conventional PCR plus Sanger sequencing.