Claims for Patent: 9,133,518

Summary for Patent: 9,133,518

Title:	Method for determining predisposition to pulmonary infection
Abstract:	Provided herein are methods and materials for diagnosing a subject\'s predisposition for pulmonary infection in a CF subject by detecting a pulmonary infection genetic marker. Pulmonary infection markers have been identified in the IL-1 gene cluster and may be useful in predicting CF disease progression and assessing a CF subject\'s response to therapy.
Inventor(s):	Levy; Hara (Bayside, WI), Gerard; Craig (Chestnut Hill, MA), Pier; Gerald (Brookline, MA), Weiss; Scott (Chestnut Hill, MA), Lange; Christoph (Cambridge, MA)
Assignee:	Presidental and Fellows of Harvard College (Cambridge, MA)
Application Number:	13/296,557
Patent Claims:	1. A method of treating a pulmonary infection in a human subject with a pulmonary infection marker, comprising: detecting a pulmonary infection marker in a sample from the subject, wherein the detection of the marker comprises: (a) providing a nucleic acid-containing sample obtained from the subject; (b) amplifying a nucleic acid comprising the marker; and (c) detecting the amplified nucleic acids, thereby detecting the marker, wherein the pulmonary infection marker is selected from the group consisting of SEQ ID NO:3, SEQ ID NO:1, SEQ ID NO:5, SEQ ID NO:7 and SEQ ID NO:15; and administering an anti-inflammatory agent or antibacterial agent to the subject in which the pulmonary infection marker is detected, thereby treating the pulmonary infection in the subject. 2. The method of claim 1, wherein the anti-inflammatory is an IL1 blocker. 3. The method of claim 2, wherein the IL1 blocker is selected from the group consisting of rilonacept, anakinra, and Zn-protoporphyrin (ZnPP). 4. The method of claim 1, wherein the pulmonary infection is associated with bacterial lung colonization. 5. The method of claim 4, wherein the bacterium is selected from the group consisting of P. aeruginosa, S. aureus, H. influenae, B. cepacia, methicillin-resistant S. aureus, S. maltophilia, and A. xylosoxidans. 6. The method of claim 1, wherein the marker is detected by sequencing. 7. The method of claim 1, wherein the marker is amplified using a pair of primers comprising the sequences selected from the group consisting of SEQ ID NO:19, SEQ ID NO:20, SEQ ID NO:21, SEQ ID NO:22, SEQ ID NO:23, SEQ ID NO:24, SEQ ID NO:25, SEQ ID NO:26, SEQ ID NO:29 and SEQ ID NO:30. 8. The method of claim 7, wherein the amplified nucleic acids are detected by hybridizing an oligonucleotide probe to the amplified product. 9. The method of claim 8, wherein the probe is labeled with a detectable label. 10. The method of claim 8, wherein the probe is an oligonucleotide comprising a SNP selected from the group consisting of SEQ ID NO:3, SEQ ID NO:1, SEQ ID NO:5, SEQ ID NO:7 and SEQ ID NO:15. 11. The method of claim 1, wherein the presence of a marker selected from the group consisting of SEQ ID NO:11, SEQ ID NO:15, and SEQ ID NO:3 is diagnostic of the subject having a predisposition for severe pulmonary infection. 12. The method of claim 1, wherein the pulmonary infection marker indicates that the subject has a predisposition for pulmonary infection.

Details for Patent 9,133,518

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	11/14/2001		2027-04-27
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249	02/27/2008		2027-04-27