CLIA Labs Offer Liquid Biopsy Tests for Cancer and Precision Medicine
We attended presentations from two emerging companies developing molecular diagnostics platforms focused in cancer.Their mission is to develop cost-effective, non-invasive diagnostic assays and biomarkers directly from blood or urine eliminating the need for tissue samples, the "liquid biopsy".With DNA sequencing broadly available it is possible to look for cancer cells or genetic material from a tumor that are circulating in blood or urine and to help detect cancer at an earlier stage.
The Company focuses on genetic markers expressed in various types of cancer and is developing non-invasive diagnostic tests for lung, bladder and breast. Lung cancer data will be presented with their collaborator the Wistar Institute at the CHEST 2016 Annual Meeting next week in Los Angeles. Lung cancer has only a 15-18% survival rate and there is a need for a confirmatory test following LDCT (Low Dose Computes Tomography) which has a high false positive rate or low specificity. After a positive result from a CT scan and prior to a biopsy the Oncocyte blood test is performed to distinguish between benign from malignant nodule growths. Preliminary results show a 76% sensitivity and 88% specificity.
Analytical verification of the test is underway to confirm results of the Wistar and research processes involving RNA extraction and the Nanostring (NASDAQ:NSTG) assay method. CLIA certification for the lab and launch of the lung cancer test is expected in the first half of 2017. The strategy for the non-invasive biomarker blood test is cost savings with value based pricing by minimizing expensive biopsies. Note: Oncocyte is a subsidiary of Biotime (NYSEMKT:BTX).
The Company offers a Precision Cancer Monitoring (NYSE:PCM) platform that tracks and quantifies levels of cell free ctDNA (circulating tumor) in urine or blood samples for detection and monitoring patients previously diagnosed with cancer. TrovaGene now provides CLIA assays for biomarkers such as BRAF,KRAS,MEK and a panel for oncogene mutations. A multigene oncogene panel will be validated by year-end 2016.The market for non-invasive blood and urine tests as an alternative to biopsy is expected to be in the $20-30B range.Urine testing has shown to be equivalent to blood and tissue testing for pancreas and lung and large scale precision medicine studies are underway. Health Network providers have recently signed on access the Trovera urine and blood based liquid biopsy for personalized cancer care. The Company has 90 issued and 73 pending patents.
Recently the ctDNA Trovera test was used to confirm the EGFR T790M resistance mutation in non-small cell lung cancer.
There are several other companies developing reference laboratory tests for ctDNA and we hope to provide potential investment opportunities for public companies in the field. In June 2016 the FDA approved the first plasma companion diagnostic (and liquid biopsy) test the Roche COBAS EGFR mutation to identify patients with non-small lung cancer (NSCLC) eligible for treatment with Tarceva (erlotinib). The liquid biopsy field shows great promise but more development and studies are needed to determine how they improve patient outcomes.
Disclosure: I am/we are long RHHBY.