secwatch.observer — SEC 8-K summary
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Issuer:     Renalytix plc (RNLXY)
CIK:        0001811115
Form:       8-K
Filed at:   2024-02-09T23:59:59+00:00
Accession:  0000950170-24-013048
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CMS publishes draft LCD for KidneyIntelX; coverage for type 2 diabetes and CKD stages 1-3b
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- CMS draft LCD covers KidneyIntelX and kidneyintelX.dkd for patients with type 2 diabetes and Stage 1–3b chronic kidney disease.
- Medicare price set at $950 per test; distinct CPT codes on 2024 Clinical Lab Fee Schedule.
- 45-day public comment period opened Feb 8, 2024; ends March 23, 2024; final LCD expected in 2024.
- Company formally requested the LCD from NGS and submitted peer-reviewed evidence; expert panel meeting held Aug 29, 2023.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1811115/000095017024013048/0000950170-24-013048-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1811115/000095017024013048/rnlx-20240209.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-013048

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer