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Sichenzia Ross Friedman Ference LLP

61 Broadway

New York, NY 10006

February 14, 2012

Securities and Exchange Commission

100 F Street, NE

Washington, DC 20549-4720

Attention: Dan Greenspan

Re:          TrovaGene, Inc.

Amendment No. 1 to Registration Statement on Form 10-12G/A

Filed December 30, 2011

File No. 000-54556

Dear Mr. Greenspan:

This letter sets forth the responses of TrovaGene, Inc., a Delaware corporation (the “Company” or “we”), to the comments received from the Staff of the Division of Corporation Finance (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated January 27, 2012 (“Comments Letter”) concerning the Company’s Amendment No. 1 to Form 10-12G/A filed on December 30, 2011(the “Filing”).

The numbers of the responses in this letter correspond to the numbers of the Staff’s comments as set forth in the Comments Letter.  For your convenience, we set forth each comment from your comment letter in bold type-face and include the Company’s response below it.

General

1.              As you are aware, your Form 10 goes effective by lapse of time within 60 days of the date filed pursuant to Exchange 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.

We are aware that our Form 10 went effective on January 24, 2012 and we note that the effectiveness of our Form 10 will commence our periodic reporting obligations under the Exchange Act even if all of the comments on our Form 10 have not been resolved.

2.              Please note that where we provide examples to illustrate what we mean by our comments, they are examples and not exhaustive 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.

We note that where the Staff provides examples to illustrate what it means by its comments, they are examples and not exhaustive lists.

Item 1. Business, page 3

3.              To the extent material, please expand the Business 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.

In Item 1 Business-Background of Amendment No. 2 to Form 10, we have added a paragraph discussing the sources and availability of the raw materials used in our research and development and the names of the principal suppliers.

Background, page 3.

4.              It is unclear from your filing whether and 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 product 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 intention.  If you intend to seek FDA approval for your product, please clearly so state on page 3 when you discuss your planned pursuit of a CE Mark, and revise the risk factor on pages 15-16 entitled “If the FDA were to begin regulating genomic tests . . .” accordingly.  Please also expand your filing to disclose when you intend to pursue regulatory approval.

In Item 1 Business- Background of Amendment No. 2 to Form 10, we have modified the disclosure to make it clear that we will determine on a case by case basis whether an FDA review is necessary.  In addition, in Item 1 Business — Our Business Strategy, we have modified our disclosure to state “If we intend to pursue FDA review ….” and deleted the clause regarding the planned pursuit of a CE mark.

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 executed out-license agreements incorporating this biomarker with Ipsogen S.A. and Asuragen, Inc., which has resulted in royalty and license fee revenues. In addition, you have also signed license agreements with various labs including LabCorp, Invivoscribe, Skyline 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 respect, the descriptions on pages F-37 and F-38 must also be expanded as necessary. Your disclosure in the Business section should include the following information:

·                  The name of each party to each material license agreement;

·                  The material obligations of each party, including any financial obligations;

·                  A description of the royalty rates payable under the agreement, expressed within a ten percent range (for example, “single digits,” “teens”, “twenties,” etc);

·                  The potential aggregate milestones 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 identified 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.

In Item 1 Business — Background of Amendment No. 2 to Form 10 we have added the requested disclosure regarding the sublicenses we have entered into.  In addition, we have filed as exhibits all of the sublicenses we have entered into.

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

In Item 1. Business — Background of Amendment No. 2 to Form 10 we have defined the abbreviation “CLIA.”

Our Technologies, page 4

7.              On page 4, you describe clinical 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 conducted under the guidance of the FDA, and that the results of these clinical trials are irrelevant to your ability to receive regulatory approval.

In Item 1. Business — Our Technologies in Amendment No. 2 to Form 10, we have modified the disclosure to state the information reflected in the comment.

8.              Please expand your discussion on page 4 to provide more detail regarding the clinical trials conducted in India. Your description 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 the accuracy of the results.

In Item 1 Business — Our Technologies in Amendment No. 2 to Form 10, we have added disclosure regarding the clinical trials conducted in India.

The Market, page 5

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

By overnight courier, we are supplementally providing the Staff with the sources for the quantified information 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.

In Item 1. Business - The Market of Amendment No. 2 to Form 10, we have defined the abbreviations, “RA,” “EGFR” and “OEM.”

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.

In Item 1 Business — Our Business Strategy  of Amendment No. 2 to Form 10, we have added disclosure discussing the significance of a CLIA lab and how it relates to the FDA approval process.

Research and Development, page 9

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

In Item 1 Business — Research and Development of Amendment No. 2 to Form 10, we have modified the disclosure to quantify the number of scientists located in our 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.

In Item 1 Business — Research and Development of Amendment No. 2 to Form 10, we have modified the language to state that the two  self-funded development projects will start in 2012.

Manufacturing and Distribution, page 10

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

In Item 1 Business — Manufacturing and Distribution, we have indicated that  we plan to introduce assays into the marketplace through ASR or LDTs in 2012.

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.

In Amendment No. 2 to Form 10, Item 1. Business — Background, we have explained the process for receiving a CE mark.

Item 1A. Risk Factors

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

16.       The title of this risk factor indicates that there is a risk to your company that your questionable ability to continue as a going concern may hinder your ability to obtain future financing. However, this risk is not discussed in the risk factor text.  Please revise accordingly.

We have revised the risk factor “Our independent registered public accounting firm has expressed doubt ….” to include the risk that our ability to continue as a going concern may hinder our ability to obtain future financing.

“We will need to raise substantial additional capital to commercialize . . .,” page 11

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

We have revised the risk factor “We will need to raise substantial additional capital to commercialize ….” to include our working capital as of February 10, 2012.

18.       You disclose in this risk factor that your existing capital resources will not be sufficient to fund your operations for the next 12 months.  Please disclose how long your existing resources will fund your operations. Please also approximate how much additional capital you will need to sustain operations for 12 months.

We have revised this risk factor to disclose how long our existing capital resources will fund our operations and how much additional capital we will need to sustain operations for the next 12 months.

19.       To the extent practicable, please quantify the additional capital you will need to advance your current product candidates to market.

We have revised this risk factor to disclose the amount of additional capital needed to advance our business strategy.

20.       On page 12 in this risk factor, you indicate that “if” your capital 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.

We have revised this risk factor to indicate that we will have to raise additional funds during

the next 12 months to continue the development and commercialization of our transrenal molecular technology.

“Reimbursement may not be available for products based upon . . .,” page 13

21.       This risk factor appears to discuss a risk that is substantially similar to the risk discussed on page 12 entitled “Our ability to successfully commercialize our technology will depend largely upon the extent to which third-party payors reimburse our tests.”  Please revise your filing to combine these risk factors.

We have combined the risk factor “Reimbursement may not be available for products based upon …” into the risk factor “Our ability to successfully commercialize our technology will depend largely upon the extent to which third-party payors reimburse our tests.”

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

22.       This risk factor appears to discuss a risk that is substantially similar to the risk immediately prior to it on page 13 entitled “Many of our competitors have financial, marketing and human resource assets greater than ours . . . .” Please revise your filing to combine these risk factors.

We have combined the risk factor “Many of our competitors have financial, marketing and human resource assets greater than ours…..” into the risk factor “If our potential medical diagnostic tests are unable to compete effectively…”

“Our failure to convince medical practitioners to order tests using . . .,” page 14

23.       This risk factor appears to discuss a risk that is substantially 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 products among physicians, patients, health care payors and the medical community.”  Please revise your filing to combine these risk factors.

We have combined the risk factor “Our failure to convince medical practitioners to order tests using …..” into the risk factor “The commercial success of our product candidates will depend upon the degree of market acceptance of these products among physicians, patients, health care payors and the medical community.”

“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 appropriate 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 have moved the last three sentences of the risk factor “Our failure to obtain human urine samples from medical institutions …” to the risk factor “The commercial success of our product candidates will depend upon the degree of market acceptance ….”

“We depend upon our officers, and if we are not able to retain them . . .,” page 14

25.       Please identify your key employees.

In the risk factor “We depend upon our officers, and if we are not able to retain them…” we have identified Dr. Antonius Schuh, our CEO, as our current key employee.

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

We have not had difficulty attracting personnel in the past.

“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 corporate priorities is to pursue and receive a CE Mark for your HPV urine-based test. However, you do not mention the risk of not receiving a CE Mark in this risk factor.  Please revise accordingly.

We have added disclosure to this risk factor with respect to the risk of not receiving a CE Mark.

“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 Medical Device Reporting.

We have added disclosure t