SecProbe.io

CORRESP
1
filename1.htm

20/20
GeneSystems, Inc.

9430
Key West Ave.

Rockville,
MD 20850

June
22, 2018

U.S.
Securities and Exchange Commission

100 F Street, N.E.

Washington, DC. 20549

Attn: John Reynolds

 Re: 20/20
                                         GeneSystems, Inc.

Offering
Statement on Form 1-A

Filed
March 9, 2018

File
No. 024-10816

Dear
Mr. Reynolds:

We
hereby submit the responses of 20/20 GeneSystems, Inc. (the “Company”) to the comments of the staff (the “Staff”)
of the U.S. Securities and Exchange Commission set forth in the Staff’s letter, dated April 5, 2018, providing the Staff’s
comments with respect to the Offering Statement on Form 1-A (the “Offering Statement”).

For
the convenience of the Staff, each of the Staff’s comments is included and is followed by the corresponding response of
the Company.  Unless the context indicates otherwise, references in this letter to “we,” “us”
and “our” refer to the Company on a consolidated basis.

Risk
Factors, page 6

 1. We
                                         note the discussion on page 17 regarding different options for ongoing reporting. Please
                                         revise where appropriate to clarify your reporting if your shares become quoted on the
                                         OTCQB.

Response:
We have revised the Offering Statement to clarify our ongoing reporting obligations if the Company’s shares of common stock
become quoted on the OTCQB, which are satisfied by remaining in compliance with (i) SEC reporting requirements, if we elect to
become a public reporting company under the Exchange Act, or (ii) Regulation A reporting requirements, if we elect not to become
a reporting company under the Exchange Act.

Description
of Business, page 25

 2. We
                                         note the statement that you believe Paula’s Test is the “first combinatorial
                                         blood test … that incorporates a machine learning algorithm.” We also note
                                         the statement that “no marketed product currently competes with our proposed OneTest
                                         multi (pan) cancer test.” Please revise to clearly differentiate how your current
                                         and pending tests differ from ones provided by other companies. For example, it appears
                                         that some public companies currently offer tests using machine learning and algorithms,
                                         and some tests appear to screen for multiple types of cancer.

Response:
We have revised the Offering Statement to differentiate how our tests differ form those of other companies.

U.S.
Securities and Exchange Commission

June
22, 2018

Page
2

Our
Commercial Approach, page 29

 3. We
                                         note statements that you “expect to eventually” make your products available
                                         to large national clinical laboratory testing chains such as LabCorp or Quest Diagnostics.
                                         Please clarify the expected timeline for any existing or planned arrangements with such
                                         third parties to the extent material. Please also revise to clarify the status of your
                                         tests. For example, the first paragraph on page 1 suggests that your products currently
                                         include OneTest; however, you state on page 28 that OneTest is “late stage”
                                         without providing an approximate timeline for commercialization. You also (1) refer to
                                         BioCheck as a “legacy” product without explaining the extent to which it
                                         is expected to generate more than de minimis revenues and (2) refer to “Lung Cancer
                                         Detection (China)” on page 28 without providing an approximate timeline for commercialization.

Response:
We have revised the Offering Statement to clarify the expected timeline for the status and commercialization of our tests. The
Company operates its own lab with a Certificate of Compliance (General Immunology) through June 2020. In May 2018, the Company
acquired, installed, and validated the automated immunoassay analyzers needed to run OneTest™. We expect to have
all of our standard operating procedures in place per CLIA requirements before the end of June 2018 at which time we expect to
widely promote OneTest™, with an initial focus in the Washington, D.C. metropolitan area. We estimate our current
capacity would be to handle up to approximately 500 tests per week. Before we exceed that capacity, which may occur before the
end of 2019, we would seek to have the biomarker tests run in external clinical labs such as LabCorp and Quest Diagnostics. This
will likely require approval from the Food and Drug Administration since the test would no longer be a Laboratory Developed Test.

Regarding
other products, the Company’s current intent is that PAULA’s Test+™ will become subsumed by OneTest™,
at least for customers with a history of smoking, since most of the biomarkers that are detected by the former are also detected
by the latter. It is possible that PAULA’s Test+™ will remain as a stand-alone test for high risk smokers and former
smokers although time is needed to make that assessment. Our Chinese lung cancer test algorithm, which is presently designed to
help with the differentiation of benign and malignant pulmonary nodules, will likely need to be integrated with Artificial Intelligence
imaging technology to become competitive. Our BioCheck® kits for screening suspicious powders remains profitable but with
limited growth potential, at least in the U.S. absent a serial anthrax incident like the one that occurred in the U.S. in 2001.

Management’s
Discussion and Analysis of Financial Condition and Results of Operations, page 33

 4. We
                                         note that you do not expect to have a predictable revenue stream in the near future and
                                         that you recently transitioned to a “potentially more profitable self-pay model.”
                                         We also note the statement that you have “payment obligations and obligations to
                                         pursue development and commercialization of diagnostic tests.” Please revise to
                                         address these topics to the extent they represent trends, demands, commitments or events
                                         that are reasonably likely to have a material effect on your net sales or revenues. In
                                         this regard, if material, please address period-to-period changes to the average selling
                                         price of Paula’s test, which you state on page 3 is about $149. Refer to Item 9(d)
                                         of Part II of Form 1-A.

Response:
We have revised our disclosure to include period-to-period changes for our products.
Based on market research conducted to date, including pre-orders, we believe that there is a substantial base of American consumers
willing to pay between $150 to $200 for our multi-cancer early detection blood (OneTest™). At an average selling
price of $175, this product would generate gross profit margins of 80% that would rise to about 90% with growing test volume as
the negotiated cost of test reagents drop from the current $30 to below $20.

U.S.
Securities and Exchange Commission

June
22, 2018

Page
3

In
addition, we have revised our disclosure to summarize our payment obligations and obligations to pursue development and commercialization
of diagnostic tests.

 5. We
                                         note your disclosure related to your sources of revenue. We also note that your website
                                         states that BioCheck “generates revenues of about $500,000 per year with Gross
                                         Profit margins of about 80%.” It also states that the company “has brought
                                         in approximately $7.5 million in grant funding.” Please advise us how these statements
                                         reconcile with the disclosure in the Form 1-A, and, as necessary, enhance your disclosure
                                         to more specifically address how the company earns revenue from grants and sales of BioCheck
                                         and other services.

Response:
We are in the process of removing such information from our website, which was incorrect. The information in the Form 1-A is correct
and, therefore, requires no further revision.

Compensation
of Directors and Executive Officers, page 42

 6. We
                                         note your disclosure that certain directors are awarded options that vest over time.
                                         Please revise this section to provide all information required by Item 11(d) of Form
                                         1-A.

Response:
We have revised the Offering Statement to disclose the compensation payable to the Company’s Chief Executive Officer and
to clarify that the Company does not otherwise have an ongoing plan or arrangement for compensation of directors and executive
officers.

Interest
of Management and Others in Certain Transactions, page 44

 7. We
                                         note your disclosure on page F-12 regarding various Investment LLCs and arrangements
                                         with immediate family members of the CEO. Please revise this section to provide all information
                                         required by Item 13 of Form 1-A and file any related agreements.

Response:
We have revised our disclosure to provide all of the information required by Item 13 of Form 1-A. We do not believe that these
agreements must be filed since they are not material.

Part
III - Exhibits

 8. Please
                                         file the escrow agreement as an exhibit to the offering statement. Refer to Item 17(8)
                                         in Part III of Form 1-A.

Response:
We have revised the Offering Statement to file the escrow agreement as an exhibit thereto.

If
you would like to discuss any of the responses to the Staff’s comments or if you would like to discuss any other matters,
please contact the undersigned at (240) 453-6339 or Louis A. Bevilacqua of Bevilacqua PLLC at (202) 869-0888 (ext 100).

    Sincerely,

    20/20 GeneSystems, Inc.

    By:
    /s/ Jonathan Cohen

    Jonathan Cohen

    Chief Executive Officer

 cc: Louis
                                         A. Bevilacqua, Esq.