IP Library Patent Application 18046261
Patent Application
App. No. 18/046,261

Far-Red Dye Probe Formulations

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Quick Facts
Patent No.
US None
App. No.
18/046,261
Abstract

Disclosed are formulations, including both liquid and lyophilized formulations, comprising a far-red dye probe and a non-linear surfactant or foamban. Also disclosed are related methods for preparing a lyophilized far-red dye probe formulation as well as related kits and diagnostic products.

Claims (45)

1 - 20 . (canceled)

21 . A method of preparing a stabilized, aqueous far-red dye probe formulation, the method comprising:

dissolving a far-red dye probe comprising a far-red dye conjugated to a carrier molecule in a diluent to provide a stabilized, aqueous far-red dye probe formulation comprising:

the far-red dye probe;

a non-linear surfactant at a concentration from about 0.5% (v/v) to about 20% (v/v); and

at least one buffering agent; and

wherein the far-red dye probe formulation is an aqueous solution.

22 . The method of claim 21 , wherein the diluent comprises the non-linear surfactant.

23 . The method of claim 21 , wherein the non-linear surfactant is selected from the group consisting of a polyoxyethylene sorbitan fatty acid ester and digitonin.

24 . The method of claim 21 , wherein the non-linear surfactant is a polyoxyethylene sorbitan fatty acid ester selected from the group consisting of polysorbate 20, polysorbate 40, and polysorbate 60.

25 . The method of claim 21 , wherein the non-linear surfactant concentration is from about 0.5% (v/v) to about 10% (v/v), from about 1% (v/v) to about 20% (v/v), or from about 1% (v/v) to about 10% (v/v).

26 . The method of claim 21 , wherein the far-red dye is a far-red cyanine dye.

27 . The method of claim 26 , wherein the far-red cyanine dye is selected from the group consisting of cyanine 5 and cyanine 5.5.

28 . The method of claim 21 , wherein the far-red dye probe in the stabilized, aqueous far-red dye probe formulation has a relative fluorescence, in relative fluorescence units (RFU), and the relative fluoresce of far-red dye probe is decreased by no more than 20% after 30 days of storage.

29 . The method of claim 21 , wherein the at least one buffering agent comprises Tris.

30 . The method of claim 29 , wherein the Tris buffering agent is present in the far-red dye probe formulation at a concentration of from about 5 mM to about 50 mM.

31 . The method of claim 21 , wherein the far-red dye probe is present in a lyophilized composition before being dissolved in the diluent.

32 . A kit comprising:

(a) a first sealed container containing a lyophilized far-red dye probe formulation prepared by a method comprising:

(i) providing a stabilized far-red dye probe solution comprising:

a far-red dye probe comprising a far-red dye conjugated to a carrier molecule;

a non-linear surfactant at a concentration from about 0.5% (v/v) to about 20% (v/v); and

at least one buffering agent;

wherein the far-red dye probe solution is an aqueous solution; and

(ii) lyophilizing the aqueous far-red dye probe solution to form the lyophilized far-red dye probe formulation; and

(b) a second sealed container containing a diluent.

33 . The kit of claim 32 , wherein the diluent comprises the non-linear surfactant.

34 . The kit of claim 33 , wherein the non-linear surfactant is selected from the group consisting of a polyoxyethylene sorbitan fatty acid ester and digitonin.

35 . The kit of claim 33 , wherein the non-linear surfactant is a polyoxyethylene sorbitan fatty acid ester selected from the group consisting of polysorbate 20, polysorbate 40, and polysorbate 60.

36 . The kit of claim 32 , wherein the far-red dye is a far-red cyanine dye.

37 . The kit of claim 36 , wherein the far-red cyanine dye is selected from the group consisting of cyanine 5 and cyanine 5.5.

38 . A diagnostic product comprising a sealed container containing a stabilized far-red dye probe formulation comprising:

a far-red dye probe comprising a far-red dye conjugated to a carrier molecule;

a non-linear surfactant at a concentration from about 0.5% (v/v) to about 20% (v/v); and

at least one buffering agent;

wherein the formulation is an aqueous solution, and further wherein:

(i) the non-linear surfactant is selected from the group consisting of a polyoxyethylene sorbitan fatty acid ester and digitonin; or

(ii) the far-red dye probe in the formulation has a relative fluorescence, in relative fluorescence units (RFU), and the relative fluoresce of far-red dye probe is decreased by no more than 20% after 30 days of storage.

39 . The diagnostic product of claim 38 , wherein the non-linear surfactant is selected from the group consisting of a polyoxyethylene sorbitan fatty acid ester and digitonin.

40 . The diagnostic product of claim 38 , wherein the non-linear surfactant is a polyoxyethylene sorbitan fatty acid ester selected from the group consisting of polysorbate 20, polysorbate 40, and polysorbate 60.

41 . The diagnostic product of claim 38 , wherein the non-linear surfactant concentration is from about 0.5% (v/v) to about 10% (v/v), from about 1% (v/v) to about 20% (v/v), or from about 1% (v/v) to about 10% (v/v).

42 . The diagnostic product of claim 38 , wherein the far-red dye is a far-red cyanine dye.

43 . The diagnostic product of claim 38 , wherein the far-red cyanine dye is selected from the group consisting of cyanine 5 and cyanine 5.5.

44 . The diagnostic product of claim 38 , wherein the far-red dye probe in the reconstituted stabilized, aqueous far-red dye probe formulation has a relative fluorescence, in relative fluorescence units (RFU), and the relative fluoresce of far-red dye probe is decreased by no more than 20% after 30 days of storage.

45 . The diagnostic product of claim 38 , wherein the stabilized far-red dye probe formulation is a stabilized, reconstituted far-red dye probe formulation.

Assignments (4)
RELEASE OF SECURITY INTEREST RECORDED AT REEL/FRAME 065286/0407 Recorded Apr 24, 2026
From: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
To: HOLOGIC, INC.; GEN-PROBE INCORPORATED; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE PRODESSE, INC.
Reel/Frame 075457/0767 →
SECURITY INTEREST Recorded Apr 8, 2026
From: BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.; CYTYC CORPORATION; SUROS SURGICAL SYSTEMS, INC.; GYNESONICS, INC.; BOLDER SURGICAL, LLC; FAXITRON BIOPTICS, LLC; HEALTH BEACONS, INC.; HOLOGIC, INC.
To: ROYAL BANK OF CANADA, AS COLLATERAL AGENT
Reel/Frame 075462/0440 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 12, 2024
From: AUBIN-WALKER, SHEILA; MAJLESSI, MEHRDAD R.; PHAM, JIMMYKIM; BOUSQUET, JOSHUA
To: GEN-PROBE INCORPORATED
Reel/Frame 066737/0300 →
SECURITY INTEREST Recorded Oct 19, 2023
From: HOLOGIC, INC.; FAXITRON BIOPTICS, LLC; BIOTHERANOSTICS, INC.; GEN-PROBE INCORPORATED; GEN-PROBE PRODESSE, INC.
To: BANK OF AMERICA, N.A., AS COLLATERAL AGENT
Reel/Frame 065286/0407 →