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CheckPoint 156-110 : Check Point Certified Security Principles Associate Exam

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Test Number : 156-110
Test Name : Check Point Certified Security Principles Associate
Vendor Name : CheckPoint
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CheckPoint certification

New publication in Nature cancer Demonstrates Signatera's means to evaluate Tumor Response to Immunotherapy | 156-110 VCE exam and exam Questions

prospective section II study indicates personalised ctDNA analysis may be used as a biomarker of efficacy throughout a large range of tumor types

SAN CARLOS, Calif., Aug. 3, 2020 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global chief in mobilephone-free DNA checking out, these days announced the book of a manuscript in Nature Cancer1 that validates the ability of its Signatera™ personalised circulating tumor DNA (ctDNA) technology to consider tumor response to immunotherapy in 25 several types of solid cancer. the whole study will also be found right here.

Natera, Inc. logo (PRNewsFoto/Natera, Inc.)

greater

"although immune checkpoint inhibitors are a pretty good tool for treating many forms of melanoma, the resolution to deal with past radiological development can every now and then be challenging as a result of skills pseudo-development," explained Lillian Siu, MD, FRCPC, BMO Chair in Precision cancer Genomics at the Princess Margaret melanoma Centre and lead investigator of the study. "we're delighted to have partnered with Natera on this landmark study, which shows that ctDNA-primarily based surveillance using the Signatera examine, at the side of imaging, may also be used to establish true disorder development and consequently help patients receive appropriate immunotherapy remedy."

Pseudo-progression is a phenomenon whereby the tumor appears larger on an preliminary scan right through medicine earlier than shrinking on subsequent scans, and it has been said in up to 1 in 10 sufferers handled with immunotherapy.2,3 The potential to differentiate genuine development from pseudo-progression, past during treatment, has emerged as a major unmet scientific want.

The prospective section II encourage examine, led by the Princess Margaret cancer Centre in Toronto, followed sufferers with advanced strong tumors being treated with the immunotherapy drug, pembrolizumab. entire exome sequencing turned into performed the usage of tumor and matched typical DNA, and then bespoke ctDNA assays had been designed using Signatera expertise. ctDNA assessments have been made at baseline in ninety four sufferers, and every three cycles all through medication in 73 patients where serial plasma samples had been attainable.

in the posted manuscript, the examine's authors concluded, "The findings from this potential analyze suggest broad medical utility for ctDNA-primarily based surveillance in patients handled with immune checkpoint blockade."

Key findings from the look at include:

  • Signatera technology detected ctDNA before medicine in 98% of instances (92/94), emphasizing its validity as a normal biomarker across tumor types.
  • ctDNA boost after simply 6 weeks of treatment, in conjunction with increasing tumor extent on imaging, turned into identified in 42% of patients (30/seventy three) and predicted remedy non-response with a hundred% accuracy. These patients bought on average 6 additional weeks of treatment that probably could have been prevented.
  • ctDNA clearance at any time factor all over treatment turned into carried out via sixteen% of patients (12/73) and turned into linked to one hundred% typical survival with a median of 25.4 months of followup past first clearance.
  • All findings have been unbiased of tumor mutational burden (TMB) and PD-L1 fame.
  • "With over 200,000 sufferers per 12 months being handled with immunotherapy,four they see a significant opportunity for serial use of Signatera to aid physicians determine treatment response previous," referred to Solomon Moshkevich, normal manager of Natera's oncology enterprise. "We suppose this novel utility could be as colossal as Signatera's use case in early-stage colorectal melanoma."

    We thank Merck for contributing the drug for this clinical trial.

    About SignateraSignatera is a custom-developed circulating tumor DNA (ctDNA) look at various for medication monitoring and molecular residual sickness (MRD) evaluation in patients in the past clinically determined with melanoma. The verify is obtainable for scientific and analysis use, and, in 2019, it become granted leap forward equipment Designation by means of the U.S. food and Drug Administration (FDA). The Signatera look at various is customized and tumor-recommended, presenting every particular person with a personalized blood verify tailor-made to healthy the interesting signature of clonal mutations found in that individual's tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at tiers down to a single tumor molecule in a tube of blood. unlike a typical liquid biopsy, Signatera isn't intended to healthy sufferers with any specific therapy. quite, it's supposed to realize and quantify how lots melanoma is left within the physique, to realize recurrence previous, and to support optimize medicine selections. Signatera examine performance has been clinically validated in diverse cancer kinds together with colorectal, non-small telephone lung, breast, and bladder cancers. Medicare has proposed insurance insurance for the use of Signatera in patients with Stage II or III colorectal melanoma, and it is anticipated to finalize that insurance resolution in 2020. Signatera has been developed and its performance traits decided by the CLIA-certified laboratory performing the verify. The check has now not been cleared or authorized by way of the us meals and Drug Administration (FDA). despite the fact FDA is exercising enforcement discretion of premarket overview and other FDA legal necessities for laboratory-developed checks within the US, certification of the laboratory is required under CLIA to make certain the excellent and validity of the checks. 

    Story continues

    About NateraNatera is a pioneer and international chief in phone-free DNA trying out. The mission of the business is to change the administration of disease global with a spotlight on girls's fitness, oncology, and organ health. Natera operates ISO 13485-licensed and CAP-approved labs certified below the clinical Laboratory development Amendments (CLIA) in San Carlos, California, and Austin, Texas. It presents proprietary genetic checking out functions to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical businesses, and genetic laboratories via its cloud-primarily based software platform. For greater assistance, visit natera.com. follow Natera on LinkedIn. 

    ahead-looking StatementsAll statements other than statements of ancient facts contained during this press free up are forward-searching statements and are not a representation that Natera's plans, estimates, or expectations might be performed. These forward-searching statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to replace the forward-looking statements. These ahead-searching statements are subject to commonplace and unknown hazards and uncertainties that can cause exact consequences to vary materially, together with with respect to their efforts to advance and commercialize new product choices, their means to efficaciously raise demand for and develop revenues for their product choices, even if the outcomes of scientific or other studies will support the use of their product offerings, their expectations of the reliability, accuracy and performance of their screening checks, or of the advantages of their screening assessments and product choices to patients, providers and payers. extra dangers and uncertainties are mentioned in better detail in "chance components" in Natera's contemporary filings on forms 10-okay and 10-Q and in different filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

    ContactsInvestor members of the family: Mike Brophy, CFO, Natera, Inc., 650-249-9090Media: Paul Greenland, VP of corporate advertising, pr@natera.com

    References:

  • Bratman SV, Yang SYC, Iafolla MAJ, et al. customized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients handled with pembrolizumab. Nat. cancer. 2020. https://www.nature.com/articles/s43018-020-0096-5
  • Borcoman E, Nandikolla A, lengthy G, Goel S, Tourneau CL. Patterns of Response and progression to Immunotherapy. Am Soc Clin Oncol Educ booklet. 2018;38:169-178.
  • Patel V. progress on Pseudoprogression. The Pathologist. https://thepathologist.com/subspecialties/progress-on-pseudoprogression. published 2018.
  • IQVIA™ Institute for Human records Science Releases world Oncology traits 2019 look at: record variety of melanoma medicine Launched in 2018 across 17 signs. IQVIA. https://www.iqvia.com/newsroom/2019/05/iqvia-institute-for-human-information-science-releases-global-oncology-tendencies-2019-look at-checklist-number-of-c. published 2019.
  •  

    View original content material to obtain multimedia:http://www.prnewswire.com/information-releases/new-booklet-in-nature-melanoma-demonstrates-signateras-capacity-to-evaluate-tumor-response-to-immunotherapy-301104783.html

    source Natera, Inc.


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