PS4
strong
Pathogenic
Met: variant-specific case-control enrichment in FinnGen, homozygous odds ratio 44.7 (95% CI 6.90-290, P=6.7e-5) versus the PS4 requirement of significantly increased prevalence in affecteds.
PMID:38036545 ('NTHL1 is a recessive cancer susceptibility gene', Nurmi et al. 2023, Scientific Reports): genotyping of candidate variants in 2482-4101 breast-cancer patients vs 1273-3985 controls, plus all coding variants in 18,786 breast-cancer cases and 182,927 controls from FinnGen. Variant-specific result: NTHL1 c.244C>T p.(Gln82Ter), homozygous OR = 44.7 (95% CI 6.90-290, P = 6.7 x 10^-5) and heterozygous OR = 1.39 (95% CI 1.18-1.64, P = 7.8 x 10^-5) for breast cancer, with a suggested high risk of colorectal, urinary-tract and basal-cell skin cancer in homozygotes.Direction check for PS4's own operator: generic ACMG/AMP 2015 PS4 requires prevalence in affecteds to be significantly increased versus controls (enrichment criterion, strengthens as the value rises). No VCEP source text defines a numeric threshold for PS4 in NTHL1 (no CSPEC/VCEP available), so the operator is taken from PS4's own definition only. Explicit inequality as written: '44.7 > 1?' yes; 95% CI 6.90-290 excludes 1; 'P = 6.7 x 10^-5 < 0.05?' yes -> met.PMID:37727376: same allele (c.244C>T p.(Gln82Ter) under NM_002528.7, originally reported as c.268C>T p.(Gln90Ter) under NM_002528.6, ClinVar ID 192319) found in homozygosity in four polyposis patients and in compound heterozygosity with c.435_446del p.(Leu146_Arg149del) (patient #5) or c.503T>C p.(Ile168Thr) (patient #6); homozygous carriers presented colorectal polyposis (<10 to >100 polyps) and colorectal cancer at ages 47-63. Provides case accrual for the same variant; no control group, so not formal case-control enrichment.