Patent SG-11201900767V-A (SG)
Title: Method of detecting an endotoxin using limulus amebocyte lysate substantially free of coagulogen
Inventor: Stumbaugh Candice
IPC: C12Q1/56
Filed: 2017-08-02
Abstract: INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 08 February 2018 (08.02.2018) WIP0 I PCT olimion °nolo omolom mEoinio oiml (10) International Publication Number WO 2018/026941 Al (51) International Patent Classification: C12Q 1/00 (2006.01) C12Q 1/56 (2006.01) C12Q 1/34 (2006.01) (21) International Application Number: PCT/US2017/045137 (22) International Filing Date: 02 August 2017 (02.08.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/370,493 03 August 2016 (03.08.2016) US (71) Applicant: LONZA WALKERSVILLE, INC. [US/US]; 8830 Biggs Ford Road, Walkersville, MD 21793 (US). (72) Inventors: STUMBAUGH, Candice; 336 Martina Drive, Chambersburg, PA 17201 (US). HERBST, David, S.; 7196 Adirondack Drive, Frederick, MD 21702 (US). NICHOLS, Kenneth, E.; 287 Crispin Lane, Falling Waters, WV 25419 (US). (74) Agent: WOODHOUSE, Scott, M.; Medler Ferro Wood- house & Mills PLLC, 8201 Greensboro Drive, Suite 1060, McLean, VA 22102 (US). = (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(ii)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: — with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) 1-1 1-1 71- O 00 1-1 O C (54) Title: METHOD OF DETECTING AN ENDOTOXIN USING LIMULUS AMEBOCYTE LYSATE SUBSTANTIALLY FREE OF COAGULOGEN (57) : The present invention is related to a method of detecting an endotoxin in a sample using a chromogenic assay, the method comprising: (a) contacting the sample with a reagent comprising limulus amebocyte lysate (LAL) and a chromogenic substrate; and (b) measuring a chromogenic effect resulting from a change in the chromogenic substrate in the presence of endotoxin in the sample; wherein the LAL is substantially free of coagulogen. The method also relates to compositions and kits comprising LAL substantially free of coagulogen, and methods of making such.