SecProbe.io

January 27, 2012
 Via E-mail

Dr. Antonius Schuh, Ph.D. Chief Executive Officer  TrovaGene, Inc. 11055 Flintkote Avenue, Suite B San Diego, CA 92121
Re: TrovaGene, Inc.
 Amendment No. 1 to Registration Statement on Form 10-12G/A  Filed December 30, 2011  File No. 000-54556

Dear Dr. Schuh:
 We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with  information so we may better understand your
disclosure.
 Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advi sing us when you will provide the requested
response.  If you do not believe our comments apply to your fact s and circumstances or do not
believe an amendment is appropriate, pl ease tell us why in your response.
 After reviewing any amendment to your filing and the information you provide in
response to these comments, we ma y have additional comments.
 General

1. As you are aware, your Form 10 goes effective by lapse of time with in 60 days of the
date filed pursuant to Excha nge Act Section 12(g)(1).  Please note that the effectiveness
of your Form 10 will commence your periodic reporting obligations under the Exchange
Act even if all of our comments have not yet been resolved.

2. Please note that where we provide examples to illustrate what we mean by our comments,
they are examples and not exhaus tive lists.  If our comments are applicable to portions of
the filing that we have not cited as examples, please make the appropriate changes in
accordance with our comments.

Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 2

 Item 1.  Business, page 3

3. To the extent material, please expand the Bu siness section to discuss the sources and
availability of the raw materials used in your  research and development, and the names of
principal suppliers.  Please refer to Item 101(h)(4)(v) of Regulation S-K.
 Background, page 3

4. It is unclear from your filing whether a nd when you intend to seek FDA approval for
your product.  Pages 4, 8, 10, and 15 suggest  you intend to seek FDA approval, yet on
page 16 you state your expectation that your pr oduct candidates will be “an LDT and not
a diagnostic kit,” and therefore not subject to FDA regulation.   Please revise your filing
to clearly explain your intent ion.  If you intend to seek FDA approval for your product,
please clearly so state on pa ge 3 when you discuss your planned pursuit of a CE Mark,
and revise the risk factor on pages 15-16 en titled “If the FDA were to begin regulating
genomic tests . . .” accordingly.  Please also expand your filing to disclose when you intend to pursue regulatory approval.

5. On page 3, you state that you in-licensed a new DNA-based biomarker specific for a
subtype of AML.  Since 2006, you have execute d out-license agreem ents incorporating
this biomarker with Ipsogen S.A. and Asurag en, Inc., which has re sulted in royalty and
license fee revenues.  In addition, you have also signed license agre ements with various
labs including LabCorp, Invivoscribe, Sky line Diagnostics, MLL Munich Leukemia and
Warnex, each of which entitles you to various  payments under certain  circumstances.
Please revise your disclosure in the Business section to describe the material terms of
each agreement.  In this resp ect, the descriptions on pages F-37 and F-38 must also be
expanded as necessary.  Your disclosure in the Business secti on should include the
following information:

 The name of each party to each material license agreement;
 The material obligations of each part y, including any financial obligations;
 A description of the royalty rates payabl e under the agreement, expressed within a
ten percent range (for example, “single digits,” “teens”, “twenties,” etc);
 The potential aggregate mile stones payable, if any;
 The amounts paid to date;
 The term of the agreement; and
 The termination provisions of the agreement.
 In addition, please file all iden tified license agreements as exhibits to your Form 10, or
provide us with a legal analysis  as to why these agreements need not be filed pursuant to
Item 601(b)(10)(2)(ii) of Regulation S-K.

6. Please define the abbreviation “CLIA” in the first instance you use this term.

Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 3

 Our Technologies, page 4

7. On page 4, you describe clini cal trials that you conducted in  India.  Please clearly
indicate in your filing, wherever  you discuss these clinical trials , that these clinical trials
have not been sanctioned by the FDA nor c onducted under the guidance of the FDA, and
that the results of these clini cal trials are irrelevant to your  ability to receive regulatory
approval.
8. Please expand your discussion on page 4 to pr ovide more detail rega rding the clinical
trials conducted in India.  Your descript ion should include the following information:

 When the clinical study was held;
 How long the clinical study was active;
 How you targeted patients to enroll;
 Whether you conducted this study with any other parties; and
 The steps taken to ensure th e accuracy of the results.

The Market, page 5

9. Please provide sources for all quantified info rmation on pages 5-8 of this section.

10. Please define the abbreviations “RA” on page 6, “EGFR” on page 7, and “OEM” on
page 8.
Our Business Strategy, page 8

11. Please expand your disclosure to describe the significance of a CLIA  lab, the term “home
brew,” and how these relate to the FDA approval process.

Research and Development, page 9

12. On page 9, you state that you have a “small group of dedicated scie ntists.”  Please
quantify the number of scientists that are located in your San Diego office.

13. You indicate that it is your “goal” to have  at least two self-funded development projects
ongoing at all times.  Please estimate when you anticipate meeting this goal.
 Manufacturing and Distribution, page 10

14. You indicate that you plan to introduce assa ys into the marketplace through ASR or
LDTs in CLIA licensed laboratories.  Please estimate when you anticipate meeting this
goal.

Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 4

 Government Regulation, page 10

15. You state on page 3 of your filing that you will  pursue a CE mark for marketing approval.
However, the process for receiving a CE mark is not described in this subsection.  Please
revise your filing accordingly.
 Item 1A.  Risk Factors

 “Our independent registered public accounti ng firm has expressed doubt . . .,” page 11

16. The title of this risk factor  indicates that there is a ri sk to your company that your
questionable ability to continue as a goi ng concern may hinder your ability to obtain
future financing.  However, this risk is not disc ussed in the risk factor text.  Please revise
accordingly.
 “We will need to raise substantial additiona l capital to commercialize . . .,” page 11

17. Please quantify your working capital as  of the latest practicable date.

18. You disclose in this risk fact or that your existing capital re sources will not be sufficient
to fund your operations for the next 12 mont hs.  Please disclose how long your existing
resources will fund your operations.  Please also approximate how much additional
capital you will need to sustai n operations for 12 months.

19. To the extent practicable, please quantify the additional capital you will need to advance
your current product candidates to market.
20. On page 12 in this risk fact or, you indicate that “if” your cap ital resources are insufficient
to meet future requirements you will have to raise additional funds to continue the
development and commercialization of your technology.  However, on page 11 you indicate that you do not have existing capital resources to  fund your operations for the
next 12 months.  Please revise this risk factor on page 12 to  clearly indicate that your
capital resources are insufficient to meet future requirements.
“Reimbursement may not be available for products based upon . . .,” page 13

21. This risk factor appears to disc uss a risk that is substantiall y similar to the risk discussed
on page 12 entitled “Our ability to succe ssfully commercialize our technology will
depend largely upon the extent to which third-pa rty payors reimburse our tests.”  Please
revise your filing to comb ine these risk factors.

Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 5

“If our potential medical diagnostic  tests are unable to compet e effectively . . .,” page 13

22. This risk factor appears to discuss a risk that is substa ntially similar to the risk
immediately prior to it on page 13 entitled “Many of our competit ors have financial,
marketing and human resource asse ts greater than ours . . . .”  Please revise your filing to
combine these risk factors.
 “Our failure to convince medical practitione rs to order tests using . . .,” page 14

23. This risk factor appears to disc uss a risk that is substantiall y similar to the risk discussed
on page 13 entitled “The commercial success of our product candidates will depend upon
the degree of market acceptance of these pr oducts among physicians, patients, health care
payors and the medical community.”  Please revise your filing to combine these risk factors.
 “Our failure to obtain human urine samples from medical institutions . . .,” page 14

24. The last three sentences of this risk factor appear to discuss a risk that is not described in
the heading of this risk factor , and appear to be more approp riate to the discussion of the
risk described in the risk factor on page 13 entitled “The commercial success of our
product candidates will depend upon the degree of market acceptance . . . .”  Please revise
your filing to incorporate the discussion of your need for the support of thought leaders
into the earlier risk factor.
 “We depend upon our officers, and if we are not  able to retain them . . .,” page 14

25. Please identify your key employees.

26. If you have had difficulty attracting pers onnel in the past, please so disclose.

“If we do not receive regulatory approvals, we will not be able to develop . . .,” page 15

27. You indicate on page 3 that one of your corporat e priorities is to pursue and receive a CE
Mark for your HPV urine-based test.  Ho wever, you do not mention the risk of not
receiving a CE Mark in this risk factor.  Please revi se accordingly.

“If the FDA were to begin regulating genomic tests, we could be forced . . .,” page 15

28. Please expand this risk factor to briefly describe the FDA regulations Quality System
Regulation and Medica l Device Reporting.

Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 6

 “We may incur substantial costs as a result of litigation or other proceedings . . .,” page 17

29. If third parties have previously  challenged the validity of your patents, please so disclose
to describe the circumstances.
 “We have not paid dividends on our comm on stock in the past . . .,” page 19

30. Please clearly state in this risk  factor that reader s should not rely on an investment in your
company if they require dividend income.
Item 2.  Management’s Discussion and Analys is of Financial Condition and Results of
Operations
Critical Accounting Policies
Royalty and License Revenues, page 21

31. Please include a description of  your collaborative agreements  to identify th e products or
product candidates that are the subject of your research.  Disclose e ach party’s rights and
obligations under the agreement and termination provisions.  To the extent that the
agreement grants licenses to any of the part ies, the terms of the license(s) should be
described.

Allowance for Doubtful Accounts, page 21

32. Please disclose the nature of your accounts receivable.  Also di sclose any significant
debtor concentration. Clarify why accounts receivable increa sed significantly during the
periods presented.
 Research and Development, page 22

33. Please provide quantitative and qualitative di sclosure about the amount of costs, both
internal and external, incurred during each peri od presented and incurred to date on each
of your major research and deve lopment projects.  To the exte nt that you cannot attribute
costs to a project, please expl ain why management does not ma intain and evaluate those
costs by project.
 Convertible Debentures, page 23

34. Please tell us what authoritative literatu re you used to account for the Forbearance
Agreement entered into during 2009 and for the subsequent modifications and the
eventual extinguishment of your  convertible debentures.

Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 7

 Results of Operations, page 23

35. Please provide a more robust discussion explai ning the change in revenues during the
three months ended September 30, 2011 and 2010;  and the nine months ended September
30, 2011 and 2010.
 Item 3.  Properties, page 25

36. Please file your lease as an exhibit to your Form 10 pursuant to Item 601(b)(10)(2)(iv) of
Regulation S-K.
 Item 5.  Directors and Executive Officers, page 26

37. Please expand the biographical information of  Ms. Cerrone to describe her business
experience from January 2005 to July 2008.  Pl ease refer to Item 401(e)(1) of Regulation
S-K.
 Director Independence, page 28

38. You state that a majority of the board consists of members that are currently
“independent,” as that term  is defined under NASDAQ listing standards.  Please identify
all independent directors.  Please refer to Item 407(a) of Regulation S-K.
 Item 6.  Executive Compensation, page 29

 Summary Compensation Table, page 29

39. Please update this table, and the compensa tion tables on page 30, with compensation
information for the fiscal year ended December 31, 2011.
 Item 9.  Market Price of and Dividends on the Registrant’s Comm on Equity and Related
Stockholder Matters, page 33

40. Please update the Equity Compensation Plan Information table on page 34 to provide
information for the fiscal year ended December 31, 2011.
41. We note your disclosure regarding equ ity compensation plans not approved by
stockholders.  Please briefly descri be the material features of these plans.  Please refer to
Item 201(d)(3) of Regulation S-K.

Dr. Antonius Schuh, Ph.D. TrovaGene, Inc. January 27, 2012 Page 8

 Item 10.  Recent Sales of Unregistered Securities, page 34

42. Regarding each instance of private placement financings, please name the persons or
identify the class of persons to whom the securities were sold.  Please refer to Item
701(b) of Regulation S-K.
 Consolidated Financial Statements

Consolidated Statements of Operations, page F-4

43. Tell us why you do not present revenues fr om royalties separately from revenues
attributable to license fees on the face of your consolidated statements of operations.
 Notes to Consolidated Financial Statements

3.  Summary of Significant Accounting Policies
Royalty and License Revenues, page F-15

44. It is unclear from your current policy note di sclosure how your policy is applied to each
of your revenue streams.  For example, typically  consideration allocate d to license fees is
recognized when earned if the license has st and-alone value.  Revenue on substantive
milestone payments is recognized in the pe riod in which the milestone is achieved.
Royalty revenue is generally recorded in the same period as the sales that generate the
royalty payment.  Please revise your policy not e here and in the MD&A to discuss your
revenue recognition policy separately for each of your revenue streams.  Please refer to
ASC 605-25 as necessary in your response.
 Consolidated Financial Statements at September 30, 2011, unaudited

45. Please revise your interim fi nancial statement disclosures based on the preceding
comments, as applicable.

We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in th