PITTSBURGH, Pennsylvania, September 8, 2021 – Cernostics, pioneer of the worlds’ first precision medicine test to predict future development risk of esophageal cancer from Barrett’s esophagus (BE), TissueCypher® Barrett’s Esophagus Assay, has become a participating (“in- network”) provider for Geisinger Health Plan (GHP)’s more than 550,000 plan members in Central, North Central and East Central Pennsylvania. The TissueCypher® Barrett’s Esophagus Assay has been a covered service for GHP members since a January 2021 decision determined that it was “medically necessary” for the evaluation of biopsies from certain BE patients, becoming the first commercial health care plan to have a coverage policy for TissueCypher.
This decision by GHP comes in response to multiple recent peer-reviewed publications that independently validated the clinical validity and clinical utility of the TissueCypher® Barrett’s Esophagus Assay.
Objectively and accurately predicting progression from BE to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) is critical as the incidence of esophageal cancer is growing in the US at one of the fastest rates of all cancers. Once diagnosed, EAC is highly lethal, so early detection and advanced warning in patients with BE by TissueCypher provides valuable clinical decision support to physicians managing these patients.
“We’ve collaborated with Cernostics in the development of the clinical evidence demonstrating the value of TissueCypher for risk-stratification of patients with BE. TissueCypher uses biomarker information not available by any other technology and has allowed us to determine optimal treatment and follow-up strategies in an informed and intelligent way. Importantly, the test can be run on previously obtained biopsies. It’s exciting to see that our patients and gastroenterologists now have access to this important technology as a covered benefit and in-network lab service,” said Dr. David Diehl, Director of Interventional Endoscopy at Geisinger Medical Center.
Mike Hoerres, Chief Executive Officer of Cernostics, added, “We are proud to work with Geisinger, one of the leading integrated healthcare delivery systems in the US, to bring TissueCypher testing to our neighbors throughout Pennsylvania. We see this as a great way to support the legacy and vision of Abigail Geisinger, delivering state-of-the-art medicine to the communities we serve right here in Pennsylvania.”
About Cernostics and TissueCypher® Barrett’s Esophagus Assay
Cernostics applies spatial biology and biologically-aware AI and machine learning (ML) to tissue diagnostics, delivering precision diagnostic testing to patients and gastroenterologists. This technology and platform are the core of the TissueCypher® Barrett’s Esophagus Assay, the world’s first precision medicine test that predicts future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). TissueCypher is indicated for BE patients with confirmed intestinal metaplasia graded non-dysplastic (ND), indefinite for dysplasia (IND) or low-grade dysplasia (LGD). TissueCypher is a proprietary Laboratory Developed Test (LDT) with its own unique CPT PLA code (0108U), available only from Cernostics’ CLIA-certified pathology laboratory. TissueCypher has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.
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