<SEC-DOCUMENT>0000950123-24-003132.txt : 20240702
<SEC-HEADER>0000950123-24-003132.hdr.sgml : 20240702
<ACCEPTANCE-DATETIME>20240408172555
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000950123-24-003132
CONFORMED SUBMISSION TYPE:	DRSLTR
PUBLIC DOCUMENT COUNT:		3
FILED AS OF DATE:		20240408

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			GRAIL, LLC
		CENTRAL INDEX KEY:			0001699031
		STANDARD INDUSTRIAL CLASSIFICATION:	SERVICES-MEDICAL LABORATORIES [8071]
		ORGANIZATION NAME:           	08 Industrial Applications and Services
		IRS NUMBER:				475117880
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		DRSLTR

	BUSINESS ADDRESS:	
		STREET 1:		1525 O'BRIEN DRIVE
		CITY:			MENLO PARK
		STATE:			CA
		ZIP:			94025
		BUSINESS PHONE:		650-771-9796

	MAIL ADDRESS:	
		STREET 1:		1525 O'BRIEN DRIVE
		CITY:			MENLO PARK
		STATE:			CA
		ZIP:			94025

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	GRAIL, LLC
		DATE OF NAME CHANGE:	20231113

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	Grail, Inc.
		DATE OF NAME CHANGE:	20170227
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<TD VALIGN="bottom" COLSPAN="3">505 Montgomery Street, Suite 2000</TD></TR>


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<TD VALIGN="top" COLSPAN="3">Tel: +1.415.391.0600 Fax: +1.415.395.8095</TD></TR>
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<TD VALIGN="top">www.lw.com</TD>
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<TD VALIGN="top">Austin</TD>
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<TD VALIGN="bottom" NOWRAP>Milan</TD></TR>
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<TD VALIGN="top">Brussels</TD>
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<TD VALIGN="bottom" NOWRAP>Orange County</TD></TR>
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<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; text-indent:4.00em; font-size:10pt; font-family:Times New Roman">April 8, 2024</P></TD>
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<TD VALIGN="top">Century City</TD>
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<TD VALIGN="bottom" NOWRAP>Paris</TD></TR>
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<TD VALIGN="top">Chicago</TD>
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<TD VALIGN="bottom" NOWRAP>Riyadh</TD></TR>
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<TD VALIGN="top">Dubai</TD>
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<TD VALIGN="bottom" NOWRAP>San Diego</TD></TR>
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<TD VALIGN="top">D&uuml;sseldorf</TD>
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<TD VALIGN="bottom" NOWRAP>San Francisco</TD></TR>
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<TD VALIGN="bottom" NOWRAP>Seoul</TD></TR>
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<TD VALIGN="top">Hamburg</TD>
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<TD VALIGN="bottom" NOWRAP>Silicon Valley</TD></TR>
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<TD VALIGN="top">Hong Kong</TD>
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<TD VALIGN="bottom" NOWRAP>Singapore</TD></TR>
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<TD VALIGN="bottom" NOWRAP>Tel Aviv</TD></TR>
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<TD VALIGN="top">Madrid</TD>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>VIA EDGAR </U></I></B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">U.S. Securities and Exchange Commission </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Division of Corporation
Finance </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">100 F Street, N.E. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Washington, D.C. 20549-6010 </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top">Attention:</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Kristin Lochhead</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Terence O&#146;Brien</P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Conlon Danberg</P> <P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Katherine Bagley</P></TD>
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<TD VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; margin-left:5.00em; text-indent:-2.50em; font-size:10pt; font-family:Times New Roman"><B>Re:&#8194;&#8201;&#8201;</B></P></TD>
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<TD VALIGN="top"><B>GRAIL, Inc.</B></TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Response to Letter dated March&nbsp;28, 2024</B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Amendment No.&nbsp;2 to</B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Draft Registration Statement
Submitted on Form <FONT STYLE="white-space:nowrap">10-12B</FONT></B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Submitted March&nbsp;11, 2024</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman"><B>CIK No.&nbsp;0001699031</B></P></TD>
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</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">To the addressee set forth above: </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On behalf of our client, GRAIL, LLC (to be converted into a corporation named GRAIL, Inc.) (the &#147;<B><I>Company</I></B>&#148;), we are
submitting this letter in response to the comments received from the staff (the &#147;<B><I>Staff</I></B>&#148;) of the U.S. Securities and Exchange Commission (the &#147;<B><I>SEC</I></B>&#148;) by letter, dated March&nbsp;28, 2024 (the
&#147;<B><I>Comment Letter</I></B>&#148;), regarding the Company&#146;s Amendment No.&nbsp;2 to Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">10-12B,</FONT> as confidentially submitted to the Staff on March&nbsp;11, 2024
(&#147;<B><I>Amendment No.</I></B><B><I></I></B><B><I>&nbsp;2</I></B>&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The Company is concurrently confidentially submitting to
the Staff Amendment No. 3 to the Draft Registration Statement on Form <FONT STYLE="white-space:nowrap">10-12B</FONT> (&#147;<B><I>Amendment No. 3</I></B>&#148;) together with this letter, via EDGAR with the SEC, which has been revised to reflect
certain revisions to Amendment No.&nbsp;2 in response to the Comment Letter as well as certain other changes.&#8195; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">For ease of review,
we have set forth below each of the numbered comments of the Staff contained in the Comment Letter in bold type followed by the Company&#146;s responses thereto. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to
them in Amendment No. 3 and all references to page numbers in such responses are to page numbers in Amendment No. 3. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>April 8, 2024</B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B> Page
2</B>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Amendment No.&nbsp;2 to Draft Registration Statement on Form
<FONT STYLE="white-space:nowrap">10-12B</FONT> Submitted March&nbsp;11, 2024 </U></I></B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Summary </U></I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Our mission is to detect cancer early, when it can be cured., page 2 </U></I></B></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left">1.</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your responses to comments 1 and 2, and reissue these comments in part. In this regard, please
revise your summary so that it is clear and prominent to investors that you do not produce or market a diagnostic test, but rather, a cancer screening test, and that this test has not been approved by the FDA. Please also make it clear and prominent
that your future business and commercialization plans include FDA approval. In your revised disclosure, please address the following comments:</B> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left"><B>&#149;</B></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>At first instance, where you disclose that you believe Galleri is clinically validated, please revise your
disclosure to make it clear that&nbsp;the Galleri test has not been approved by the FDA or an equivalent foreign regulator, and that the Galleri test has been validated as a screening test rather than a diagnostic test. In this regard, where you
discuss &#147;detection&#148; by Galleri, please ensure that it is clear that this detection required additional diagnostic testing. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and has revised the disclosure on pages 2, 3, 6, 124, 132, 133,
135 and 182 of Amendment No. 3 accordingly. </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left"><B>&#149;</B></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>Where you make claims about the accuracy of your Galleri test, including at first instance, please provide
data to support your claims, or include a cross reference to the data elsewhere in your filing. Please also clarify that &#147;accuracy&#148; in this context does not mean that the Galleri test itself was used to provide a cancer diagnosis. In
addition, please provide additional context for your statement that &#147;we estimate that by adding Galleri to the five standard of care single-cancer screening tests (breast, cervical, colorectal, lung cancer, and prostate), there is potential to
detect many more cancers at an earlier stage, which could translate into the potential to avert approximately 100,000 deaths per year in the United States as measured by five-year survival, or 39% of the five-year deaths expected if not for early
detection by Galleri,&#148; including that there is no guarantee Galleri will be added to the current standard of care screening. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:9%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and has revised the disclosure on pages 3, 121, 122, 124, 133
and 137 of Amendment No. 3 accordingly. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>April 8, 2024</B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B> Page
3</B>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>2.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your response to comment 3 and your revised disclosure that your DAC test is a &#147;medium- to
longer-term objective.&#148; Please revise your disclosure to provide an estimated timeframe for &#147;medium- to longer-term.&#148; </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and has revised the disclosure on pages&nbsp;6, 124 and 142 of
Amendment No.&nbsp;3 accordingly. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Risks Relating to Our Business and Industry </U></I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>We may be unable to develop and commercialize new products, including enhanced versions of current products., page&nbsp;41 </U></I></B></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>3.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your revised disclosure in response to previous comment 6 regarding bridging studies for new or
enhanced versions of your current products and <FONT STYLE="white-space:nowrap">re-issue</FONT> the comment in part. Your response to comment 11 from our January&nbsp;8, 2024 comment letter, included in your January&nbsp;29, 2024 response letter:
</B></P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left"><B>&#149;</B></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>noted that &#147;in the near term, enhancements are focused on improvements to Galleri and, in particular, on
automation, panel size, and other scaling improvements and updates to the machine-learning classifier&#148; and that &#147;[f]uture enhancements may also include a reduction in panel size to enable additional scaling, as well as further training of
the classifier on additional data for potential future improvement;&#148; </B></P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="3%" VALIGN="top" ALIGN="left"><B>&#149;</B></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>in addition to bridging studies, discussed the need to conduct
<FONT STYLE="white-space:nowrap">&#147;a&nbsp;non-inferiority&nbsp;study</FONT> compared to the relevant current version of Galleri using clinical study and real world evidence data (obtained through Galleri&#146;s current commercial use as an
LDT);&#148; </B></P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left"><B>&#149;</B></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>explained that because of the bridging study, &#147;the Company does not believe the changes will impact the
Company&#146;s ability to rely on previously-collected data generated from earlier versions of the Company&#146;s products;&#148; and </B></P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="5%">&nbsp;</TD>
<TD WIDTH="3%" VALIGN="top" ALIGN="left"><B>&#149;</B></TD>
<TD WIDTH="1%" VALIGN="top">&nbsp;</TD>
<TD ALIGN="left" VALIGN="top"> <P ALIGN="left" STYLE=" margin-top:0pt ; margin-bottom:0pt; font-family:Times New Roman; font-size:10pt"><B>also noted that &#147;[a]s a contingency plan,
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">if&nbsp;non-inferiority&nbsp;or&nbsp;non-concordance&nbsp;cannot</FONT></FONT> be established, the Company can revert to the prior classifier and version of the test used in the
existing version of Galleri.&#148; </B></P></TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><B>Please include similar disclosure&nbsp;in the Information Statement when
discussing potential enhanced versions of your products, or otherwise&nbsp;briefly explain what changes or improvements you expect to make to the enhanced versions of your current products, and if you believe these changes will impact your ability
to&nbsp;rely on previously-collected data on earlier versions of your products in connection with your&nbsp;submission for marketing authorization (or certification) of your products. </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and has revised the disclosure on pages&nbsp;9, 11, 33, 34,
43, 127, 128, 139 and 140 of Amendment No.&nbsp;3 accordingly. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>April 8, 2024 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B> Page
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Risks Relating to Regulation and Legal Compliance </U></I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Our multi-cancer detection tests are a new approach to cancer screening, which present a number of novel and complex issues..., page 61
</U></I></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>4.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your revised disclosure in response to previous comment 7 and
<FONT STYLE="white-space:nowrap">re-issue</FONT> the comment in part. In your January&nbsp;29, 2024 response letter, you noted that &#147;following several <FONT STYLE="white-space:nowrap">pre-submissions</FONT> to the FDA regarding the
Company&#146;s proposed clinical studies, and a meeting with the FDA in June 2023, the Company received feedback on several aspects of the clinical validation pathway for Galleri PMA. First, the FDA will permit the number of cancer-type specific
clinical samples required for the Company&#146;s proposed cancer type claims to be based on the prevalence of each particular cancer type in the intended use population. Second, the FDA will not require the Company to perform a <FONT
STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">head-to-head</FONT></FONT> comparison of Galleri and standard of care screening methods as a prerequisite for PMA approval, and will instead address such comparative data as part of
labelling or at a later date. Third, the FDA will permit GRAIL to return results to ordering providers on any cancer signal of origin detected by Galleri, regardless of whether GRAIL has sufficient clinical evidence for an affirmative claim for that
cancer type.&#148; Please include this information in your disclosure as it provides important context to the risk that it is difficult to predict what information you will need to submit to obtain approval of a PMA from the FDA. Alternatively,
please advise us why you do not believe this information is material or should be disclosed in the Information Statement. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company acknowledges the Staff&#146;s comment and respectfully advises the Staff that it does not believe this information
is material or should be disclosed in the Information Statement. While the Company believes the statements in the January&nbsp;29, 2024 response letter are helpful and responsive to give the Staff the requested additional context in response to its
comment, the Company respectfully submits that the details noted are not material and do not provide significant additional context beyond the current statements on the same page in the Information Statement, which assert that (i)&nbsp;the FDA has
never granted marketing authorization for a multi-cancer detection test and is working to inform its thinking on how to assess these types of tests, (ii)&nbsp;the FDA requirements that will govern multi-cancer detection tests, as well as the breadth
and nature of data the Company must provide the FDA, to support the proposed intended use, may be subject to change, (iii)&nbsp;the Company has been engaged and will continue to engage the FDA, but the FDA may raise additional questions or request
additional information, and (iv) &#147;we cannot be certain whether we will receive FDA approval for Galleri and whether the studies we have conducted, are currently conducting, or plan to conduct, will be sufficient to provide the data that the FDA
requires to support a proposed intended use.&#148; The Company respectfully submits that the material risks regarding the information needed to obtain approval of a PMA, including the fact that the full scope of
</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>April 8<U></U>, 2024</B> </P>
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5</B>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">
such information is subject to change due to the novel nature of MCED, are appropriately addressed in the Information Statement. In response to the Staff&#146;s comment, however, the Company
revised the disclosure on page&nbsp;63 of Amendment No. 3 to note that discussions with the FDA and any feedback from the FDA regarding the PMA process are preliminary and non-binding in nature. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Reasons for the <FONT STYLE="white-space:nowrap">Spin-Off,</FONT> page 100 </U></I></B></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>5.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note the removal of references to outside advisors from the Information Statement in response to previous
comment 8 and <FONT STYLE="white-space:nowrap">re-issue</FONT> the comment in part. With respect to any information and analyses from outside advisors that the Illumina board has already received and that have aided the board in its consideration of
strategic alternatives, please provide a more detailed legal analysis describing why the reports and recommendations provided by these outside advisors are not material to the board&#146;s decision. If the board is still evaluating potential
divestment transactions and has not made a final determination to move forward with the <FONT STYLE="white-space:nowrap">Spin-Off,</FONT> please note this in your next response letter and provide any materiality analysis in the context of the
board&#146;s ultimate decision once known. To the extent that the board receives additional information and analyses from outside advisors in connection with its evaluation of the <FONT STYLE="white-space:nowrap">Spin-Off,</FONT> including with
respect to any final determination to move forward with the <FONT STYLE="white-space:nowrap">Spin-Off</FONT> rather than any of the other potential divestment transactions, please include disclosure regarding the third party advisors and their
recommendations in a subsequent amendment or provide us with a legal analysis describing why this information is not material. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and additional disclosure has been added to the Information
Statement with respect to the Illumina Board&#146;s ongoing evaluation of potential divestment transactions, including the identity and role of Illumina&#146;s outside advisors, on page&nbsp;102. GRAIL respectfully informs the Staff that it has been
informed by Illumina that as of the date hereof the Illumina Board has not made a final determination as to which divestment alternative it will pursue and that the draft disclosure will be revised as necessary when the Illumina Board makes a final
determination. GRAIL further informs the Staff that it has been advised by Illumina that none of Illumina&#146;s outside advisors have made a recommendation to Illumina as to which divestment option to elect and that it will update the relevant
disclosure if a recommendation is made, although it is not currently anticipated that any such recommendation will be made. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Management&#146;s
Discussion and Analysis of Financial Condition and Results of Operations </U></I></B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Research and Development and Research and
Development&#151;Related Parties, page 181 </U></I></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>6.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your revised disclosure that you expect your research and development expenses to plateau over the
coming years as your existing clinical studies and development of your automated platform conclude. Please revise your disclosure to provide an estimated timeframe for &#147;the coming years.&#148; </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and has revised the disclosure on page&nbsp;188 of Amendment
No. 3 accordingly. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>April 8<U></U>, 2024</B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B> Page
6</B>
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 </P> <P STYLE="font-size:12pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Goodwill Impairment, page 182 </U></I></B></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>7.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your disclosure that &#147;[i]n the third quarter of 2023, we concluded the sustained decrease in
Illumina&#146;s stock price and overall market capitalization during the quarter was a triggering event indicating the fair value of GRAIL might be less than its carrying amount that led us to test goodwill for impairment,&#148; and &#147;[w]e
recognized an additional goodwill impairment of $608.5&nbsp;million in 2023 primarily due to changes to expected timing of revenue and a higher discount rate.&#148; Please revise your filing to provide a risk factor discussing the risks associated
with this impairment and possible future impairments or explain why you do not believe a risk factor is warranted. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and has added a risk factor on page&nbsp;40 of Amendment No. 3
accordingly. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Results of Operations, Comparison of Fiscal Year 2023 to Fiscal Year 2022 </U></I></B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Screening Revenue and Screening Revenue&#151;Related Parties, page 184 </U></I></B></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>8.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We reference the 90% increase in revenue from fiscal year 2022 to fiscal year 2023. Please revise to provide
greater insight into the contributors to the significant increase in revenue, including the underlying reasons for the increase in Galleri sales volume. Reference Item 303(a)-(b) of Regulation <FONT STYLE="white-space:nowrap">S-K</FONT> and the
three principal objectives of MD&amp;A, as noted in SEC Release <FONT STYLE="white-space:nowrap">No.&nbsp;33-8350.</FONT> </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and has revised the disclosure on page&nbsp;190 of Amendment
No. 3 accordingly. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U>Development Services Revenue, page 184 </U></I></B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>9.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your disclosure that &#147;[t]he increase in development services revenue of $2.4&nbsp;million was
primarily due to new pilots initiated with biopharmaceutical partners in fiscal year 2023.&#148; In an appropriate place in your filing, please describe the terms of these pilots with biopharmaceutical partners, if material.
</B></P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and has revised the disclosure on
page&nbsp;190 of Amendment No. 3 accordingly. The Company respectfully advises the Staff that the terms of these pilots are not material. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>April 8, 2024</B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B> Page
7</B>
 </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="margin-top:0pt;margin-bottom:0pt">


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 </P> <P STYLE="font-size:12pt; margin-top:0pt; margin-bottom:0pt">&nbsp;</P>
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I><U><FONT STYLE="white-space:nowrap">Non-GAAP</FONT> Financial Measures, page 190 </U></I></B></P>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="4%" VALIGN="top" ALIGN="left"><B>10.</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>We note your response to comment 14. You state that the bonuses were allocated amongst all employees in good
standing below the executive leadership team level and that no additional services were required to be provided by the employees above and beyond their normal employment compared to other similar roles and responsibilities. Therefore, it appears
that these costs represent cash compensation, which is a normal, recurring operating expense. As such, we request that you discontinue including this adjustment in your <FONT STYLE="white-space:nowrap">non-GAAP</FONT> measures for any period
presented in accordance with Rule 100(b) of Regulation G as interpreted by Question 100.01 of the <FONT STYLE="white-space:nowrap">Non-GAAP</FONT> Financial Measures Compliance&nbsp;&amp; Disclosure Interpretations, as updated December&nbsp;13,
2022. </B></P></TD></TR></TABLE> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman"><I>Response</I>: The Company respectfully acknowledges the Staff&#146;s comment and submits it believes that
excluding the amounts subject to bonuses is consistent with the guidance in Question 100.01 of the <FONT STYLE="white-space:nowrap">Non-GAAP</FONT> Financial Measures Compliance and Disclosure Interpretation, as updated December&nbsp;13, 2022,
because such payments will not repeat on a regular or irregular basis, and are not otherwise related to the Company&#146;s operations, revenue generating activities, business strategy, industry or regulatory environment. As these bonuses were tied
specifically to the <FONT STYLE="white-space:nowrap">one-time</FONT> event of the Company&#146;s acquisition by Illumina, so long as the respective employees remained a Company employee, these payments are not related to the core aspects of the
Company&#146;s underlying business and are instead specifically tied to the acquisition. For example, the expenses impacted one historical period and do not carry across multiple periods. In addition, the Company notes that expenses relating to the
recurring bonus plans are included in the <FONT STYLE="white-space:nowrap">non-GAAP</FONT> measures as these are considered normal, recurring operating expenses and the payments are made in connection with the Company&#146;s execution of business
operations and strategy. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">As a result, the Company believes that excluding expenses for the acquisition bonuses paid to employees related
to acquisitions from the <FONT STYLE="white-space:nowrap">non-GAAP</FONT> financial measures is useful to both management and investors because it facilitates comparability of period to period results. Additionally, management does not consider
acquisition-related bonuses in evaluating post-acquisition performance, as such charges are not representative of any underlying, ongoing business. The Company believes that excluding these expenses from the
<FONT STYLE="white-space:nowrap">non-GAAP</FONT> measures is useful to investors because it provides meaningful supplemental information regarding the Company&#146;s core operating performance. The Company further believes that excluding such
expenses does not result in the <FONT STYLE="white-space:nowrap">non-GAAP</FONT> financial measures being misleading. In response to the Staff&#146;s comment, the Company revised the disclosure on page&nbsp;198 of Amendment No. 3 to note the
non-recurring nature of the expense. </P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>* * * </B></P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>April 8, 2024</B> </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B> Page
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">We hope the foregoing answers are responsive to your comments. Please do not hesitate to
contact me by telephone at (714) <FONT STYLE="white-space:nowrap">755-8051</FONT> with any questions or comments regarding this correspondence. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Very truly yours,</TD></TR>
<TR STYLE="font-size:1pt">
<TD HEIGHT="16"></TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Ross McAloon</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">Ross McAloon</TD></TR>
<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="bottom">of LATHAM&nbsp;&amp; WATKINS LLP</TD></TR>
</TABLE></DIV> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">cc:</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Robert Ragusa, GRAIL, LLC </P></TD></TR></TABLE>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Abram Barth, GRAIL, LLC </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Charles
E. Dadswell, Illumina, Inc. </P> <P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">W. Alex Voxman, Latham&nbsp;&amp; Watkins LLP </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Andrew Clark, Latham&nbsp;&amp; Watkins LLP </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Alexa Berlin, Latham&nbsp;&amp; Watkins LLP </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Andrew J. Pitts, Cravath, Swaine&nbsp;&amp; Moore LLP </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Ting S. Chen, Cravath, Swaine&nbsp;&amp; Moore LLP </P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; margin-left:4%; font-size:10pt; font-family:Times New Roman">Daniel J. Cerqueira, Cravath, Swaine&nbsp;&amp; Moore LLP </P>
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