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Posted On: 01/03/2017 9:42:43 AM
Post# of 22876
$IDXG: Interpace Diagnostics Announces Agreement with Blue Cross Blue Shield (BCBS) Center for Clinical Effectiveness to Support Enhanced Coverage
8:00 AM ET 1/3/17 | PR Newswire
Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risks of cancer, announced today that the Company has entered in to an Agreement with the Blue Cross Blue Shield (BCBS) Association's Center for Clinical Effectiveness "Evidence Street", a program that, while not making coverage decisions, provides the Company with the opportunity to provide available evidence for its molecular Thyroid and Pancreas tests, to support further coverage determinations among Blue Cross Blue Shield and other health plans. Blue Cross Blue Shield's 36 independent plans and Companies account for approximately 106 million covered lives in the U.S.
As part of the Agreement, Interpace will work with Evidence Street to develop the optimal ways for the Company to secure and preserve ongoing coverage for not only its currently marketed products but also for those tests in the pipeline being launched in the near future. All of Interpace's currently marketed products are covered regionally by Medicare and numerous commercial plans, including certain BCBS plans.
While the BCBS plans apply numerous criteria in their evaluation of technologies, the two criteria most heavily weighted are clinical utility and patient outcomes. The Company has conducted numerous studies for their products in both its Endocrine (Endo) franchise, i.e. ThyGenX(R) and ThyraMir(R), and Gastrointestinal (GI) franchise including PancraGen(R) and BarreGen(R) for pancreatic and esophageal cancer respectively. The data from these studies have been published in multiple peer-reviewed publications such as Journal of Clinical Endocrinology and Metabolism, American Journal of Gastroenterology, and Endoscopy. These publications provide favorable conclusions regarding the clinical utility of the Company's molecular tests. The ECRI Institute, another independent review organization, published a review of PancraGen in April 2016, in which it concluded "PancraGen is more predictive of real life patient management than current guidelines."
Jack E. Stover, President and CEO of Interpace Diagnostics stated, "We are excited about our evolving relationship with Blue Cross and Blue Shield's Evidence Street which, we believe, will help ensure that we continue to develop and provide the information and data necessary to support and secure broader based insurance coverage and reimbursement for all of our products. This relationship is another important milestone in our reimbursement strategy and, when added to our recent AETNA insurance approval for ThyraMIR and New York State approval to market ThyGenX, bodes well for our commercial prospects in 2017 and beyond."
About Thyroid Nodules, ThyGenX and ThyraMIR testing
According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
About Pancreatic Cysts and PancraGEN
PancraGEN is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cancer risk assessment. PancraGEN is 90% accurate, according to clinical studies, enabling effective risk stratification of patients. Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics is a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests; PancraGen for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics' mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.
8:00 AM ET 1/3/17 | PR Newswire
Interpace Diagnostics Corp. (NASDAQ: IDXG), a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risks of cancer, announced today that the Company has entered in to an Agreement with the Blue Cross Blue Shield (BCBS) Association's Center for Clinical Effectiveness "Evidence Street", a program that, while not making coverage decisions, provides the Company with the opportunity to provide available evidence for its molecular Thyroid and Pancreas tests, to support further coverage determinations among Blue Cross Blue Shield and other health plans. Blue Cross Blue Shield's 36 independent plans and Companies account for approximately 106 million covered lives in the U.S.
As part of the Agreement, Interpace will work with Evidence Street to develop the optimal ways for the Company to secure and preserve ongoing coverage for not only its currently marketed products but also for those tests in the pipeline being launched in the near future. All of Interpace's currently marketed products are covered regionally by Medicare and numerous commercial plans, including certain BCBS plans.
While the BCBS plans apply numerous criteria in their evaluation of technologies, the two criteria most heavily weighted are clinical utility and patient outcomes. The Company has conducted numerous studies for their products in both its Endocrine (Endo) franchise, i.e. ThyGenX(R) and ThyraMir(R), and Gastrointestinal (GI) franchise including PancraGen(R) and BarreGen(R) for pancreatic and esophageal cancer respectively. The data from these studies have been published in multiple peer-reviewed publications such as Journal of Clinical Endocrinology and Metabolism, American Journal of Gastroenterology, and Endoscopy. These publications provide favorable conclusions regarding the clinical utility of the Company's molecular tests. The ECRI Institute, another independent review organization, published a review of PancraGen in April 2016, in which it concluded "PancraGen is more predictive of real life patient management than current guidelines."
Jack E. Stover, President and CEO of Interpace Diagnostics stated, "We are excited about our evolving relationship with Blue Cross and Blue Shield's Evidence Street which, we believe, will help ensure that we continue to develop and provide the information and data necessary to support and secure broader based insurance coverage and reimbursement for all of our products. This relationship is another important milestone in our reimbursement strategy and, when added to our recent AETNA insurance approval for ThyraMIR and New York State approval to market ThyGenX, bodes well for our commercial prospects in 2017 and beyond."
About Thyroid Nodules, ThyGenX and ThyraMIR testing
According to the American Thyroid Association, approximately 15% to 30% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis for the presence of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer. ThyraMIR is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGenX and ThyraMIR are covered by both Medicare and Commercial insurers.
About Pancreatic Cysts and PancraGEN
PancraGEN is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cancer risk assessment. PancraGEN is 90% accurate, according to clinical studies, enabling effective risk stratification of patients. Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.
About Interpace Diagnostics Group, Inc.
Interpace Diagnostics is a company that provides clinically useful molecular diagnostic tests and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for better patient diagnosis and management. The Company currently has three commercialized molecular tests; PancraGen for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics' mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science.
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