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SEC Company Response from ORASURE TECHNOLOGIES INC (OSUR) (CIK 0001116463) (OSUR) — Sep 29, 2009

ORASURE TECHNOLOGIES INC (OSUR) (CIK 0001116463)
Date: Sept. 29, 2009 · CIK: 0001116463 · Accession: 0001193125-09-199942

AI Filing Summary & Sentiment

Referenced dates: August 31, 2009

Date
September 29, 2009
Author
Not clearly detected
Form
CORRESP
Company
ORASURE TECHNOLOGIES INC (OSUR) (CIK 0001116463)

Letter

Securities and Exchange Commission Division of Corporation Finance Washington, D.C. 20549 Re: OraSure Technologies, Inc. (the “Company”) Form 10-K for the Year Ended December 31, 2008 (“10-K Report”) SEC File No. 1-16537

Dear Ms. Sherman:

This letter responds to the comments of the staff (“Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) contained in your letter dated August 31, 2009 (the “Comment Letter”) with respect to the above-referenced 10-K Report. Below we have reprinted these comments in bold, followed by our responses.

Comment 1 (Supply and Manufacturing, p.12)

Staff Comment:

It appears that upon termination of your agreement with BMX you purchased a two-year supply of HIV antigen required to manufacture the Western blot test. In your disclosure, you indicate that your current supply will be sufficient for at least the next several years. Please confirm that you will provide in future filings a more specific estimate as to when you will exhaust your reserves. Alternatively, please tell us why you believe that this information is not material. For instance, if you have made or anticipate being able to make alternative arrangements, please clearly disclose in future filings.

Company Response:

Supplementally, the Company advises the Staff that since the filing of the 10-K Report, the Company has made arrangements to purchase HIV-1 antigen from a subcontractor that had historically been used by BMX to manufacture this product for resale by BMX to the Company. The Company intends to negotiate a long-term supply contract with this party in the near future.

[*Confidential Treatment Requested by OraSure Technologies, Inc.]

Consequently, we believe the remaining inventory level following termination of the BMX contract, as described in the 10-K Report, is no longer material or relevant to investors. The Company’s future filings will describe the status of this alternate source of HIV-1 antigen supply.

Comment 2 (Domestic Regulations, p.17)

Staff Comment:

Refer to the penultimate paragraph of this section. With a view toward disclosure in future filings, please explain more fully the significance of the waivers you have acquired. Do the waivers apply to your laboratories or those of your customers or both? Are the waivers subject to certain restrictions? Can they expire? Please clarify.

Company Response:

We assume this comment refers to the discussion of the waiver for two of our products (i.e., the OraQuick ADVANCE® HIV test and Q.E.D.® rapid alcohol test) under the Clinical Laboratory Improvements Amendments of 1988 (“CLIA”), which appears at the top of page 18 of the 10-K Report. We will clarify in the Company’s future filings that a CLIA waiver is issued for particular tests that meet certain requirements established by the statute and related regulations (i.e., tests that employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly). A CLIA waiver does not expire. A CLIA waiver is important in that it expands the number of customers that can potentially use such a product beyond CLIA-certified laboratories to include both laboratories and non-laboratories that have not complied with the quality control, training and other requirements under CLIA.

The CLIA waiver related to our OraQuick ADVANCE® test has had a significant impact on the Company, and is fully discussed on page 4 of the 10-K Report. Sales of our OraQuick® test accounted for $35.3 million, or approximately 50% of our total revenues for 2008. As noted on page 4 of the 10-K Report, we received a CLIA waiver for the use of this test with oral fluid and fingerstick and venous whole blood. In the absence of a CLIA waiver, this test would be available for use by approximately 40,000 locations in the U.S. that are certified under CLIA to perform moderately complex tests. However, as a result of the receipt of a CLIA waiver, the test can also be used by approximately 140,000 additional sites in the U.S. not certified under CLIA to perform moderately complex tests. This would include non-laboratory customers such as outreach clinics, community-based organizations and physicians’ offices. We believe the discussion on pages 4 and 18 of the 10-K Report adequately describes the significance of the CLIA waiver obtained for our OraQuick ADVANCE® HIV test.

Our Q.E.D. ® test accounted for $1.3 million, or only approximately 1.8%, of our total 2008 revenues. Although we believe the receipt of a CLIA waiver has also expanded the customer base that can potentially use this product, given the relatively small amount of revenue

-2-

[*Confidential Treatment Requested by OraSure Technologies, Inc.]

generated by the Q.E.D.® product line, we do not believe further discussion of this issue is material or useful for investors.

Subject to the clarification described above, we believe there is adequate disclosure in the 10-K Report regarding the significance of the CLIA waivers.

Comment 3 (The Unavailability of Certain Products Distributed by a Third-Party, p. 26)

Staff Comment:

We note your disclosure that BMX sold the only oral fluid HIV-1 EIA screening test. In future filings, please revise to disclose more prominently that, in BMX’s absence, you will be forced to conduct clinical trial and seek FDA approval for an alternative test. In addition, please expand this risk factor to discuss more fully the risk that you may not receive FDA approval.

Company Response:

[*A01] Our future filings will describe this recent change in circumstances and indicate that the previously disclosed clinical trials will not be required.

Comment 4 (Financial Statements - Note 8. Income Taxes, p. F-17)

Staff Comment:

We note that you recorded the valuation allowance of $25,978,167, which is equal to 100% of your deferred tax assets. You disclosed that “Given the uncertainty surrounding the magnitude and length of the current economic condition, [your] loss in 2008, and [your] projection of a loss in 2009, [you] determined that it is more likely than not [you] will not realize the benefits associated with [your] net deferred tax assets in the immediate future. We note approximately $17 Million out of your approximately $26 Million deferred tax assets is net operating loss carry forwards, net of tax effect. While we note your discussion about your valuation allowance in your Critical Accounting Estimates, it is still not clear to us how you determined that the entire balance of the deferred tax asset should have been reserved when approximately 88% out of your total federal net operating loss carry forwards will be expired on and beyond 2017. Please explain to us the basis of your analysis whereby you are projecting that it is more likely than not that you will not be able to utilize your net operating loss carry forward in 2017 and beyond. Please provide us with your analysis of available evidence, both positive and negative, that you considered in determining your need for a full valuation allowance at December 31, 2008.

-3-

[*Confidential Treatment Requested by OraSure Technologies, Inc.]

Company Response:

Supplementally, we advise the Staff of the following evidence which we considered when determining the need for a full valuation allowance in relation to our net deferred tax asset balance. We have followed the guidance provided by Paragraph 17(e) of Statement of Financial Accounting Standards (“SFAS”) 109, “Accounting for Income Taxes,” which calls for a reduction of deferred tax assets by a valuation allowance, if “... based on the weight of available evidence, it is more likely than not (a likelihood of more than 50 percent) that some portion of all of the deferred tax assets will not be realized.” We considered the following positive and negative evidence in reaching our conclusion that a full valuation allowance was necessary at December 31, 2008:

Positive evidence:

•

The Company is a leader in the rapid oral fluid testing industry, which is a part of the growing medical diagnostics industry;

•

The Company has existing contracts with domestic and international distributors and customers that we believe will generate taxable book income in future years. At December 31, 2008, we believed the future cash flows to be received from revenues generated by our long-lived assets and intangible assets (property and equipment, and patents and product rights, respectively), would exceed their book value and as such, we did not recognize any impairment loss on the value of those assets for the year ended December 31, 2008;

•

The Company has several products in varying stages of development within its research and development product pipeline that could be a source of future revenues;

•

As a tax planning strategy, the Company could make an election under §59(e) of the U.S. Internal Revenue Code to capitalize certain research and development expenses, within the limitations prescribed therein, thereby extending the potential expiration of certain operating loss carryforwards which would expire within the next several years; and

•

Long carryforward periods are permitted under U.S. tax law for utilization of our federal and most state net operating loss carryforwards and tax credits.

Negative evidence:

•

The Company has a history of pre-tax losses and an accumulated deficit of $127 million at December 31, 2008. Our Company was formed on September 29, 2000. Prior to formation, our predecessor companies also incurred significant pre-tax losses. Since our inception, our pre-tax income or (loss) for each year ended December 31, was as follows:

$ (12,722,187 )

(3,399,000 )

(3,342,473 )

(1,108,947 )

-4-

[*Confidential Treatment Requested by OraSure Technologies, Inc.]

(559,642 )

9,718,898

9,061,453

4,293,775

(8,747,968 )

•

In the fourth quarter of 2008, the Company completed its budgeting process, which projected a pre-tax loss of approximately [*A02] for fiscal year 2009. In fiscal 2007, the Company recorded pre-tax income of $4.3 million, and in 2008, a pre-tax loss of $8.7 million, which included $4.9 million in other income from a litigation settlement in that same fiscal year. With the budgeted pre-tax loss expected in 2009, the Company would be in a cumulative three-year pre-tax loss position of approximately [*A03] as of December 31, 2009. As indicated in Paragraph 23 of SFAS 109, forming a conclusion that a valuation allowance is not needed is difficult when there is a significant piece of negative evidence to overcome, such as a cumulative loss in recent years.

•

The Company has not paid federal income taxes in the current or prior fiscal years, with the exception of alternative minimum taxes, and therefore, carryback of losses is not available.

•

Some of the primary drivers of future revenue growth for our Company are products that are in varying stages of development and that will be subject to regulation by the U.S. Food and Drug Administration (“FDA”) or other governmental or public health agencies. The process of obtaining FDA approval is inherently uncertain and can involve lengthy and detailed laboratory testing, human clinical trials, sampling activities, and other costly, time-consuming procedures. The approval process can by complex and lengthy. Failure to obtain or any delay in obtaining FDA approval for new products could significantly reduce our future revenues, increase our costs, and adversely affect our financial performance. As indicated, there is uncertainty surrounding the timing and cost of regulatory approvals, if obtained. As such, we cannot predict with any level of accuracy, the potential impact on future revenues or expenses associated with obtaining regulatory approval of new products.

•

The uncertainty surrounding the magnitude and length of the global recession makes predicting future results from current operations more difficult than in previous years.

•

At December 31, 2008, the Company did not have any significant sales backlog.

•

The reversal of existing temporary differences or deferred tax liabilities is not significant on an annual basis.

•

The Company is involved in patent infringement litigation, which alleges that the manufacture and sale of our primary rapid oral fluid HIV testing device infringes a patent held by another party. During fiscal 2008, sales of this product accounted for 49.6% of the Company’s $71 million in total revenues. In the event we are unable to successfully defend against the current litigation, or it is determined that a license to this patent is required and we cannot obtain such a license on reasonable terms, our ability to sell this device may be limited, which would adversely affect our results of operations, pre-tax income, cash flows, and our

-5-

[*Confidential Treatment Requested by OraSure Technologies, Inc.]

overall business. As of December 31, 2008, we were unable to predict with any level of certainty the resolution of this unsettled circumstance and we expected to incur substantial legal expenses in 2009 as a result of this litigation.

•

In order to remain competitive, we must regularly commit substantial resources to research and development and the commercialization of new products. The research and development process can take a significant amount of time from inception to commercial product launch. During 2008, 2007, and 2006, we incurred $20.3 million, $14.1 million, and $8.6 million, respectively, in research and development expenses. We expect to continue to incur significant costs from our ongoing research and development activities, even though future products may not be commercialized or approved by the FDA.

At December 31, 2008, we believed the negative evidence noted above far outweighed the positive evidence presented. Given the level of our pre-tax loss in 2008 and our expected pre-tax loss in 2009, we believed that we could be in a cumulative three-year pre-tax loss position even through [*A04]. Our ability to forecast future revenues and pre-tax earnings beyond 2009 is impacted by the uncertainties and unsettled circumstances described above, especially those associated with regulatory approval and clinical development expenses for our future products. We advise the Staff that this was recently proven to be true, as indicated by the June 25, 2009 Form 8-K we filed, stating that the FDA did not approve our application for approval of our rapid oral-fluid HCV test as originally submitted, but rather, is now requiring us to perform additional clinical studies in support of the test, which we believe could cost an additional [*A05]. At December 31, 2008, we did not believe that we could reliably forecast annual pre-tax earnings beyond 2009 to the level necessary to realize our deferred tax assets. As such, we did not believe that it was more likely than not that we could realize our deferred tax assets in the future, and accordingly, we recorded a full valuation allowance against our net deferred tax assets.

Comment 5 (Financial Statements - Note 12. Other Income, p. F-23)

Staff Comment:

We see that you entered into a settlement and license agreement with Schering-Plough in January 2008 to resolve your patent infringement litigation and Schering paid you $4.9 million which you recorded as other income. In future filings please reclassify this income within operating income, or tell us in detail why you believe this income is properly classified in non-operating inc

Show Raw Text
CORRESP
1
filename1.htm

Correspondence

 [*Confidential Treatment Requested by OraSure Technologies, Inc.]

 September 29, 2009

 Transmitted Via

 EDGAR and Facsimile

 Ms. Julie Sherman

 Reviewing Accountant

 Securities and Exchange Commission

 Division of Corporation Finance

 450 Fifth Street, N.W.

 Washington, D.C. 20549

Re:
OraSure Technologies, Inc. (the “Company”)

 Form 10-K for the Year Ended December 31, 2008

 (“10-K Report”) SEC
File No. 1-16537

 Dear Ms. Sherman:

 This letter responds to the comments of the staff (“Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) contained in your letter
dated August 31, 2009 (the “Comment Letter”) with respect to the above-referenced 10-K Report. Below we have reprinted these comments in bold, followed by our responses.

 Comment 1 (Supply and Manufacturing, p.12)

 Staff Comment:

 It appears that upon termination of your agreement with BMX you purchased a two-year supply of HIV antigen required to manufacture the Western blot test.
In your disclosure, you indicate that your current supply will be sufficient for at least the next several years. Please confirm that you will provide in future filings a more specific estimate as to when you will exhaust your reserves.
Alternatively, please tell us why you believe that this information is not material. For instance, if you have made or anticipate being able to make alternative arrangements, please clearly disclose in future filings.

 Company Response:

 Supplementally, the Company advises the Staff that since the filing of the 10-K Report, the Company has made arrangements to purchase HIV-1 antigen from a subcontractor that had historically been used by BMX to manufacture this product for
resale by BMX to the Company. The Company intends to negotiate a long-term supply contract with this party in the near future.

 [*Confidential Treatment Requested by OraSure Technologies, Inc.]

Consequently, we believe the remaining inventory level following termination of the BMX contract, as described in the 10-K Report, is no longer material or relevant to investors. The
Company’s future filings will describe the status of this alternate source of HIV-1 antigen supply.

 Comment 2 (Domestic Regulations,
p.17)

 Staff Comment:

 Refer to the penultimate paragraph of this section. With a view toward disclosure in future filings, please explain more fully the significance of the waivers you have acquired. Do the waivers apply to your laboratories or those of your
customers or both? Are the waivers subject to certain restrictions? Can they expire? Please clarify.

 Company Response:

We assume this comment refers to the discussion of the waiver for two of our products (i.e., the OraQuick
ADVANCE® HIV test and Q.E.D.® rapid alcohol test) under the Clinical Laboratory Improvements Amendments of 1988 (“CLIA”), which appears at the top of page 18 of the 10-K Report. We
will clarify in the Company’s future filings that a CLIA waiver is issued for particular tests that meet certain requirements established by the statute and related regulations (i.e., tests that employ methodologies that are so simple
and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly). A CLIA waiver does not expire. A CLIA waiver is important in that it expands the number
of customers that can potentially use such a product beyond CLIA-certified laboratories to include both laboratories and non-laboratories that have not complied with the quality control, training and other requirements under CLIA.

 The CLIA waiver related to our OraQuick ADVANCE® test has had a significant impact on the Company, and is fully discussed on page 4 of the 10-K Report. Sales of our OraQuick® test accounted for $35.3 million, or approximately 50% of our total revenues for 2008. As noted on page 4 of the
10-K Report, we received a CLIA waiver for the use of this test with oral fluid and fingerstick and venous whole blood. In the absence of a CLIA waiver, this test would be available for use by approximately 40,000 locations in the U.S. that are
certified under CLIA to perform moderately complex tests. However, as a result of the receipt of a CLIA waiver, the test can also be used by approximately 140,000 additional sites in the U.S. not certified under CLIA to perform moderately complex
tests. This would include non-laboratory customers such as outreach clinics, community-based organizations and physicians’ offices. We believe the discussion on pages 4 and 18 of the 10-K Report adequately describes the significance of the CLIA
waiver obtained for our OraQuick ADVANCE® HIV test.

 Our Q.E.D. ® test accounted for $1.3 million, or only approximately 1.8%, of our total 2008 revenues. Although we believe the receipt of a CLIA waiver has also expanded the
customer base that can potentially use this product, given the relatively small amount of revenue

 -2-

 [*Confidential Treatment Requested by OraSure Technologies, Inc.]

generated by the Q.E.D.® product line, we do not
believe further discussion of this issue is material or useful for investors.

 Subject to the clarification described above,
we believe there is adequate disclosure in the 10-K Report regarding the significance of the CLIA waivers.

 Comment 3 (The Unavailability
of Certain Products Distributed by a Third-Party, p. 26)

 Staff Comment:

 We note your disclosure that BMX sold the only oral fluid HIV-1 EIA screening test. In future filings, please revise to disclose more prominently that, in
BMX’s absence, you will be forced to conduct clinical trial and seek FDA approval for an alternative test. In addition, please expand this risk factor to discuss more fully the risk that you may not receive FDA approval.

 Company Response:

 [*A01]
Our future filings will describe this recent change in circumstances and indicate that the previously disclosed clinical trials will not be required.

 Comment 4 (Financial Statements - Note 8. Income Taxes, p. F-17)

 Staff Comment:

 We note that you recorded the valuation allowance of $25,978,167, which is equal to 100% of your deferred tax assets. You disclosed that “Given the
uncertainty surrounding the magnitude and length of the current economic condition, [your] loss in 2008, and [your] projection of a loss in 2009, [you] determined that it is more likely than not [you] will not realize the
benefits associated with [your] net deferred tax assets in the immediate future. We note approximately $17 Million out of your approximately $26 Million deferred tax assets is net operating loss carry forwards, net of tax
effect. While we note your discussion about your valuation allowance in your Critical Accounting Estimates, it is still not clear to us how you determined that the entire balance of the deferred tax asset should have been reserved when approximately
88% out of your total federal net operating loss carry forwards will be expired on and beyond 2017. Please explain to us the basis of your analysis whereby you are projecting that it is more likely than not that you will not be
able to utilize your net operating loss carry forward in 2017 and beyond. Please provide us with your analysis of available evidence, both positive and negative, that you considered in determining your need for a full valuation allowance at
December 31, 2008.

 -3-

 [*Confidential Treatment Requested by OraSure Technologies, Inc.]

 Company Response:

 Supplementally, we advise the Staff of the following evidence which we considered when determining the need for a full valuation allowance in relation to our net deferred tax asset balance. We have
followed the guidance provided by Paragraph 17(e) of Statement of Financial Accounting Standards (“SFAS”) 109, “Accounting for Income Taxes,” which calls for a reduction of deferred tax assets by a valuation allowance, if
“... based on the weight of available evidence, it is more likely than not (a likelihood of more than 50 percent) that some portion of all of the deferred tax assets will not be realized.” We considered the following positive and
negative evidence in reaching our conclusion that a full valuation allowance was necessary at December 31, 2008:

 Positive evidence:

•

 The Company is a leader in the rapid oral fluid testing industry, which is a part of the growing medical diagnostics industry;

•

 The Company has existing contracts with domestic and international distributors and customers that we believe will generate taxable book income in
future years. At December 31, 2008, we believed the future cash flows to be received from revenues generated by our long-lived assets and intangible assets (property and equipment, and patents and product rights, respectively), would exceed
their book value and as such, we did not recognize any impairment loss on the value of those assets for the year ended December 31, 2008;

•

 The Company has several products in varying stages of development within its research and development product pipeline that could be a source of future
revenues;

•

 As a tax planning strategy, the Company could make an election under §59(e) of the U.S. Internal Revenue Code to capitalize certain research and
development expenses, within the limitations prescribed therein, thereby extending the potential expiration of certain operating loss carryforwards which would expire within the next several years; and

•

 Long carryforward periods are permitted under U.S. tax law for utilization of our federal and most state net operating loss carryforwards and tax
credits.

 Negative evidence:

•

 The Company has a history of pre-tax losses and an accumulated deficit of $127 million at December 31, 2008. Our Company was formed on
September 29, 2000. Prior to formation, our predecessor companies also incurred significant pre-tax losses. Since our inception, our pre-tax income or (loss) for each year ended December 31, was as follows:

 2000

$
(12,722,187
)

 2001

(3,399,000
)

 2002

(3,342,473
)

 2003

(1,108,947
)

 -4-

 [*Confidential Treatment Requested by OraSure Technologies, Inc.]

 2004

(559,642
)

 2005

9,718,898

 2006

9,061,453

 2007

4,293,775

 2008

(8,747,968
)

•

 In the fourth quarter of 2008, the Company completed its budgeting process, which projected a pre-tax loss of approximately [*A02] for fiscal year
2009. In fiscal 2007, the Company recorded pre-tax income of $4.3 million, and in 2008, a pre-tax loss of $8.7 million, which included $4.9 million in other income from a litigation settlement in that same fiscal year. With the budgeted pre-tax loss
expected in 2009, the Company would be in a cumulative three-year pre-tax loss position of approximately [*A03] as of December 31, 2009. As indicated in Paragraph 23 of SFAS 109, forming a conclusion that a valuation allowance is not
needed is difficult when there is a significant piece of negative evidence to overcome, such as a cumulative loss in recent years.

•

 The Company has not paid federal income taxes in the current or prior fiscal years, with the exception of alternative minimum taxes, and therefore,
carryback of losses is not available.

•

 Some of the primary drivers of future revenue growth for our Company are products that are in varying stages of development and that will be subject to
regulation by the U.S. Food and Drug Administration (“FDA”) or other governmental or public health agencies. The process of obtaining FDA approval is inherently uncertain and can involve lengthy and detailed laboratory testing, human
clinical trials, sampling activities, and other costly, time-consuming procedures. The approval process can by complex and lengthy. Failure to obtain or any delay in obtaining FDA approval for new products could significantly reduce our future
revenues, increase our costs, and adversely affect our financial performance. As indicated, there is uncertainty surrounding the timing and cost of regulatory approvals, if obtained. As such, we cannot predict with any level of accuracy, the
potential impact on future revenues or expenses associated with obtaining regulatory approval of new products.

•

 The uncertainty surrounding the magnitude and length of the global recession makes predicting future results from current operations more difficult
than in previous years.

•

 At December 31, 2008, the Company did not have any significant sales backlog.

•

 The reversal of existing temporary differences or deferred tax liabilities is not significant on an annual basis.

•

 The Company is involved in patent infringement litigation, which alleges that the manufacture and sale of our primary rapid oral fluid HIV testing
device infringes a patent held by another party. During fiscal 2008, sales of this product accounted for 49.6% of the Company’s $71 million in total revenues. In the event we are unable to successfully defend against the current litigation, or
it is determined that a license to this patent is required and we cannot obtain such a license on reasonable terms, our ability to sell this device may be limited, which would adversely affect our results of operations, pre-tax income, cash flows,
and our

 -5-

 [*Confidential Treatment Requested by OraSure Technologies, Inc.]

overall business. As of December 31, 2008, we were unable to predict with any level of certainty the resolution of this unsettled circumstance and we expected to incur substantial legal
expenses in 2009 as a result of this litigation.

•

 In order to remain competitive, we must regularly commit substantial resources to research and development and the commercialization of new products.
The research and development process can take a significant amount of time from inception to commercial product launch. During 2008, 2007, and 2006, we incurred $20.3 million, $14.1 million, and $8.6 million, respectively, in research and
development expenses. We expect to continue to incur significant costs from our ongoing research and development activities, even though future products may not be commercialized or approved by the FDA.

 At December 31, 2008, we believed the negative evidence noted above far outweighed the positive evidence presented. Given the level of our pre-tax loss
in 2008 and our expected pre-tax loss in 2009, we believed that we could be in a cumulative three-year pre-tax loss position even through [*A04]. Our ability to forecast future revenues and pre-tax earnings beyond 2009 is impacted by the
uncertainties and unsettled circumstances described above, especially those associated with regulatory approval and clinical development expenses for our future products. We advise the Staff that this was recently proven to be true, as indicated by
the June 25, 2009 Form 8-K we filed, stating that the FDA did not approve our application for approval of our rapid oral-fluid HCV test as originally submitted, but rather, is now requiring us to perform additional clinical studies in support
of the test, which we believe could cost an additional [*A05]. At December 31, 2008, we did not believe that we could reliably forecast annual pre-tax earnings beyond 2009 to the level necessary to realize our deferred tax assets. As such, we
did not believe that it was more likely than not that we could realize our deferred tax assets in the future, and accordingly, we recorded a full valuation allowance against our net deferred tax assets.

 Comment 5 (Financial Statements - Note 12. Other Income, p. F-23)

 Staff Comment:

 We see that you entered into a settlement and license agreement with
Schering-Plough in January 2008 to resolve your patent infringement litigation and Schering paid you $4.9 million which you recorded as other income. In future filings please reclassify this income within operating income, or tell us in detail why
you believe this income is properly classified in non-operating inc