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  1. 101.
    But most importantly, we were able to develop a very simple dual threshold classifier that gives a clear result in 90% of blood draws. At ... 10 mutant copies/mL (0.25% VAF) it can reassure patients ... above 100 copies/mL (2.5% VAF) are associated with at least a 90% chance of progression. We ... article is openly available at https://www.jmdjournal.org/article/S1525
    https://www.amp.org/about/newsroom/amp-blog-content/new-technique-to-measure-cir...
  2. 102.
    L37713), available at https://www.cms.gov/medicare-coverage-database/ ... 376*1&Cntrctr=376&DocTy pe=2%7c3%7c4&bc=AQABAAIAAAAA& 2 Centers for Disease ... for Coronavirus Disease 2019 (COVID-19), available at https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical ... Security Act Implementation Part 42, available at https://www.cms.gov/files/document/FFCRA-Part
    https://www.amp.org/AMP/assets/File/advocacy/FINAL_Sign-On Letter to CMS_Coverag...
  3. 103.
    Separately, three FQ calibrators with 11 SNV at VAF ≥5% (range 5% to 33.5%) as determined by digital droplet PCR were ... from the calibrators had VAFs within 10% of the target value; 78% of calls were within 5%. No sites reported VAF 5% in the calibrator samples, consistent with each ... known or likely pathogenic variant in 13% of neuropathy patients and 17% of
    https://www.amp.org/AMP/assets/File/awards/young_investigator/WinningAbstracts20...
  4. 104.
    Carcinoma BRAF sequence variant (30%, mostly p.V600E), fusion ( 5%) diagnosis, treatment IHC (BRAF V600E), NGS (DNA, RNA), ddPCR RET (30%) fusion diagnosis, treatment NGS (DNA, RNA) DICER1 (10%) sequence variant familial cancer risk NGS (DNA) NTRK1 ... Mesoblastic Nephroma NTRK3 fusion (ETV6::NTRK3 in ~70%) diagnosis, treatment IHC (pan-TRK; screening), FISH or
    https://www.amp.org/AMP/assets/File/education/MIMP/Pediatric_SolidTumors.pdf?pas...
  5. 105.
    g., 50-80% risk of breast cancer and 20-50% risk of ovarian cancer, among others).6 These ... the issuance of patents covering an estimated 20% of the human genome.16 Defining “useful” to ... Tests Could Broaden, NY TIMES (Jun. 13, 2013), https://www.nytimes.com/2013/06/14/business/after ... Ruling on Gene Patenting (Jun. 13. 2013) https://www.nih.gov/about-nih/who-we
    https://www.amp.org/AMP/assets/2019-07-25 Coalition Letter Opposing Draft Legisl...
  6. 106.
    g., 50-80% risk of breast cancer and 20-50% risk of ovarian cancer, among others).6 These ... the issuance of patents covering an estimated 20% of the human genome.16 Defining “useful” to ... Tests Could Broaden, NY TIMES (Jun. 13, 2013), https://www.nytimes.com/2013/06/14/business/after ... Ruling on Gene Patenting (Jun. 13. 2013) https://www.nih.gov/about-nih/who-we
    https://www.amp.org/AMP/assets/2019-06-03_Section_101_Legislation_Sign_On_Letter...
  7. 107.
    While we are supportive of MAC coverage for these tests for patients at all 1 https://www.amp.org/AMP/assets/File/advocacy/ ... Testing for Lynch Syndrome (L35024), available at https://www.cms.gov/medicare-coverage-database/details ... ver=50&SearchType=Advanced&CoverageSelection=Local&ArticleType=BC%7cSAD%7cRTC%7cReg&PolicyType=Both&s=48&KeyWord=Lynch+syndrome
    https://www.amp.org/AMP/assets/File/advocacy/ReconsiderationPatientSignOn-FINAL....
  8. 108.
    and interpreted by board-1 https://www.federalregister.gov/documents/2024/05/ ... 08935/medical-devices-laboratory-developed-tests 2 https://www.whitehouse.gov/presidential-actions/2025/02 ... to FDA’s own estimates, over 90% of affected laboratories are small businesses. Most ... regulate LDTs as medical devices under 3 https://www.fda.gov/about-fda/economic-impact
    https://www.amp.org/AMP/assets/File/advocacy/AMP_Letter_to_HHS_Sec_RFK_Jr._on_La...
  9. 109.
    1 https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=290&bc=AAAAAAAAAAQAAA%3D%3D 2 https://www.palmettogba.com/moldx ASSOCIATION FOR MOLECULAR PATHOLOGY Education. Innovation & Improved Patient Care. Advocacy. 9650 Rockville Pike. Suite E205, Bethesda, Maryland 20814 Tel: 301-634-7939 | Fax: 301-634-7995 | amp@amp.
    https://www.amp.org/AMP/assets/AMPComments-HHSRFI-HealthcareChoiceCompetition-1-...
  10. 110.
    Information myeloproliferative neoplasms (MPNs) since 1% commonly understood to be the ... JAK2 V617F at a VAF 1%), CALR, MPL and/or CSF3R may ... a result of less than 1% for JAK2 as a negative result ... JAK2 of less than 1% is typically of uncertain clinical ... between JAK2 assays validated to 1% versus less than 1% and the clinical reasoning for this
    https://www.amp.org/AMP/assets/File/advocacy/AMP_CAP_MolDX_Comments_SEP24.PDF?pa...
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