SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Jun 4, 2021–
Veracyte, Inc. (Nasdaq: VCYT) right this moment introduced that Medicare Administrative Contractors Palmetto GBA, WPS and CGS Directors, LLC have finalized their protection insurance policies for Decipher Bladder, a genomic subtyping instrument that helps physicians handle therapy choices for sufferers with bladder most cancers. These native protection determinations (LCDs) make Decipher Bladder the primary genomic check to be coated by Medicare for such sufferers. Developed via the Medicare MolDX program, the insurance policies will grow to be efficient July 18, 2021, and supply a framework for different taking part MACs to observe.
Noridian Healthcare Options, one other Medicare Administrative Contractor, is anticipated to equally finalize its draft LCD, which is able to make Decipher Bladder a coated profit for greater than 62 million Medicare beneficiaries. In the US, greater than 80,000 people are recognized with bladder most cancers yearly, roughly 44,000 of which can have the non-metastatic, Stage I-IIIa illness indicated in these insurance policies.
“Physicians treating sufferers with bladder most cancers are confronted with complicated and probably life-changing therapy choices, together with whether or not or to not prescribe neoadjuvant chemotherapy or proceed on to radical cystectomy,” mentioned Tina Nova, Ph.D., Veracyte’s normal supervisor, urologic cancers. “Research have demonstrated that information of a person’s bladder-tumor molecular subtypes can assist information these choices, over and above medical options alone. The protection choices introduced right this moment will make it attainable for physicians to entry this vital genomic data.”
The Decipher Bladder check is supported by a number of peer-reviewed medical research demonstrating its means to determine which sufferers have a better danger of upstaging to non-organ confined illness at surgical procedure and which sufferers could profit essentially the most from neoadjuvant remedy. The check additionally can be utilized to determine neuroendocrine-like and immune-infiltrated subtypes, which can have implications for future therapeutic methods.
Decipher Bladder is a genomic check that measures the molecular profile of bladder most cancers utilizing gene expression evaluation from transurethral resected bladder tumor specimens. It was developed for bladder most cancers sufferers with muscle-invasive illness who face the query of quick cystectomy or systemic therapy within the neoadjuvant setting previous to cystectomy (NAC). The assay outcomes are reported as certainly one of 5 molecular subtypes (Luminal, Luminal-Infiltrated, Basal, Basal Claudin Low or Neuroendocrine-like), every of which has distinct organic composition, medical conduct and predicted profit from NAC.
Veracyte (Nasdaq: VCYT) is a world genomic diagnostics firm that improves affected person care by offering solutions to medical questions, informing prognosis and therapy choices all through the affected person journey in most cancers and different ailments. The corporate’s rising menu of genomic assessments leverages advances in genomic science and expertise, enabling sufferers to keep away from dangerous, pricey diagnostic procedures and quicken time to acceptable therapy. The corporate’s assessments in lung most cancers, prostate most cancers, breast most cancers, thyroid most cancers, bladder most cancers and idiopathic pulmonary fibrosis can be found to sufferers and its lymphoma subtyping and renal most cancers assessments are in growth. With Veracyte’s unique international license to a best-in-class diagnostics instrument platform, the corporate is positioned to ship its assessments to sufferers worldwide. Veracyte is predicated in South San Francisco, California. For extra data, please go to www.veracyte.com and observe the corporate on Twitter (@veracyte).
Cautionary Observe Relating to Ahead-Trying Statements
This press launch accommodates forward-looking statements, together with, however not restricted to, our statements associated to our plans, targets, expectations (monetary and in any other case) or intentions. Ahead-looking statements could be recognized by phrases similar to: “seems,” “anticipate,” “intend,” “plan,” “count on,” “imagine,” “ought to,” “could,” “will,” “positioned,” “designed” and related references to future intervals. Precise outcomes could differ materially from these projected or prompt in any forward-looking statements. These statements contain dangers and uncertainties, which might trigger precise outcomes to vary materially from our predictions, and embody, however will not be restricted to amongst others, our means to realize and preserve Medicare protection for our assessments, together with Decipher Bladder. Extra components that will affect these forward-looking statements could be present in Merchandise 1A –“Danger Components” in our Annual Report on Kind 10-Ok filed with the SEC on February 22, 2021 and in our Quarterly Report on Kind 10-Q filed with the SEC on Might 10, 2021. A duplicate of those paperwork could be discovered on the Traders part of our web site at www.veracyte.com. These forward-looking statements converse solely as of the date hereof and Veracyte particularly disclaims any obligation to replace these forward-looking statements or the explanation why precise outcomes may differ, whether or not on account of new data, future occasions or in any other case.
Veracyte, the Veracyte emblem, Decipher, Decipher GRID, Afirma, Percepta, Envisia, Prosigna, Lymphmark, “Know by Design” and “Extra about You” are registered emblems of Veracyte, Inc. and its associates within the U.S. and chosen nations. nCounter is the registered trademark of NanoString Applied sciences, Inc. within the U.S. and chosen nations and utilized by Veracyte underneath license.
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PUB: 06/04/2021 09:24 AM/DISC: 06/04/2021 09:24 AM