|5.60 => Potential for share price to add another zero.|
"One such tool, the pigmented lesion assay (PLA), is a gene expression test that helps rule out melanoma and the need for a surgical biopsy of atypical pigmented lesions. The PLA is based on a new platform technology for noninvasive genomic testing of the skin, which allows the analysis of samples collected from adhesive patches.11,22,24,25,26,27 In contrast to the current VAH pathway, the PLA has a very high NPV (>99%) that reduces the probability of missing melanomas from about 17% using the current standard of care (NPV of 83%) to less than 1%.26,27 In addition, the noninvasive sampling leads to dramatic reduction in surgical biopsies and subsequent excisions. The aim of this study was to demonstrate the economic implications of the noninvasive PLA compared with the current standard of care, the VAH pathway."
PLA CMS approval window initiates Q4 (10/1/19)..LCD MolDX: Pigmented Lesion Assay (DL38051)
"The Company filed an application for a technology assessment for its Pigmented Lesion Assay, or PLA, with MolDX (Medicare) in April of 2018, and the comment period for the accompanying Medicare Draft Local Coverage Decision, or Draft LCD, closed in August of 2018. In March 2019, a Draft LCD proposed favorable coverage for the PLA. The final policy is expected by the Company in the second half of 2019 and the Company expects to experience a significant revenue increase after CMS approval because of the opportunity to approach private payors. The Company believes that, if Medicare coverage is granted, PLA may generate significant revenues in the second and third years following such coverage grant."
------------------- "Opportunities multiply as they are seized" -- Sun Tzu circa 500 B.C. -------------------