News & Events

• May 10, 2010
  

  Urinary Biomarkers Trefoil Factor 3 and Albumin Enable Early Detection of Kidney Tubular Injury

  Yu Y, Jin H, Holder D, Ozer JS, Villarreal S, Shughrue P, Shi S, Figueroa DJ, Clouse H, Su M, Muniappa N, Troth SP, Bailey W, Seng J, Aslamkhan AG, Thudium D, Sistare FD, Gerhold DL. Urinary Biomarkers Trefoil Factor 3 and Albumin Enable Early Detection of Kidney Tubular Injury. Nature Biotechnology. 2010 May;28(5):470–7.

   

• May 10, 2010
  

  Kidney injury Molecule-1 Outperforms Traditional Biomarkers of Kidney Injury in Preclinical Biomarker Qualification Studies

  Vaidya VS, Ozer JS, Dieterle F, Collings FB, Ramirez V, Troth S, Muniappa N, Thudium D, Gerhold D, Holder DJ, Bobadilla NA, Marrer E, Perentes E, Cordier A, Vonderscher J, Maurer G, Goering PL, Sistare FD, Bonventre JV. Kidney Injury Molecule-1 Outperforms Traditional Biomarkers of Kidney Injury in Preclinical Biomarker Qualification Studies. Nature Biotechnology. 2010 May;28(5):478–85.

   

• May 10, 2010
  

  Towards Consensus Practices to Qualify Safety Biomarkers for Use in Early Drug Development

  Sistare FD, Dieterle F, Troth S, Holder DJ, Gerhold D, Andrews-Cleavenger D, Baer W, Betton G, Bounous D, Carl K, Collins N, Goering P, Goodsaid F, Gu YZ, Guilpin V, Harpur E, Hassan A, Jacobson-Kram D, Kasper P, Laurie D, Lima BS, Maciulaitis R, Mattes W, Maurer G, Obert LA, Ozer J, Papaluca-Amati M, Phillips JA, Pinches M, Schipper MJ, Thompson KL, Vamvakas S, Vidal JM, Vonderscher J, Walker E, Webb C, Yu Y. Towards Consensus Practices to Qualify Safety Biomarkers for Use in Early Drug Development. Nature Biotechnology. 2010 May;28(5):446–54.

• May 10, 2010
  

  A Panel of Urinary Biomarkers to Monitor Reversibility of Renal Injury and a Serum Marker with Improved Potential to Assess Renal Function

  Ozer JS, Dieterle F, Troth S, Perentes E, Cordier A, Verdes P, Staedtler F, Mahl A, Grenet O, Roth DR, Wahl D, Legay F, Holder D, Erdos Z, Vlasakova K, Jin H, Yu Y, Muniappa N, Forest T, Clouse HK, Reynolds S, Bailey WJ, Thudium DT, Topper MJ, Skopek TR, Sina JF, Glaab WE, Vonderscher J, Maurer G, Chibout SD, Sistare FD, Gerhold DL. A Panel of Urinary Biomarkers to Monitor Reversibility of Renal Injury and a Serum Marker with Improved Potential to Assess Renal Function. Nature Biotechnology. 2010 May;28(5):486–94.

• May 10, 2010
  

  Renal Biomarker Qualification Submission: A Dialog Between the FDA-EMEA and Predictive Safety Testing Consortium

  Dieterle F, Sistare F, Goodsaid F, Papaluca M, Ozer JS, Webb CP, Baer W, Senagore A, Schipper MJ, Vonderscher J, Sultana S, Gerhold DL, Phillips JA, Maurer G, Carl K, Laurie D, Harpur E, Sonee M, Ennulat D, Holder D, Andrews-Cleavenger D, Gu YZ, Thompson KL, Goering PL, Vidal JM, Abadie E, Maciulaitis R, Jacobson-Kram D, Defelice AF, Hausner EA, Blank M, Thompson A, Harlow P, Throckmorton D, Xiao S, Xu N, Taylor W, Vamvakas S, Flamion B, Lima BS, Kasper P, Pasanen M, Prasad K, Troth S, Bounous D, Robinson-Gravatt D, Betton G, Davis MA, Akunda J, McDuffie JE, Suter L, Obert L, Guffroy M, Pinches M, Jayadev S, Blomme EA, Beushausen SA, Barlow VG, Collins N, Waring J, Honor D, Snook S, Lee J, Rossi P, Walker E, Mattes W. Renal Biomarker Qualification Submission: A Dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nature Biotechnology. 2010 May;28(5):455–62.