OraSure Technologies, Inc. (NASDAQ:OSUR) today announced an
update regarding the status of its application for U.S. Food and
Drug Administration (�FDA�) approval of an OraQuick� Hepatitis C
(�HCV�) test for professional use and its clinical program for an
OraQuick� HIV-1/2 test for sale in the consumer or over-the-counter
(�OTC�) market. In addition, the Company announced its efforts to
address manufacturing challenges recently experienced with respect
to its OraQuick ADVANCE� rapid HIV-1/2 antibody test.
OraQuick� HCV Test
During the fourth quarter of 2008, the Company filed a premarket
approval application (�PMA�) with the FDA for approval of an
OraQuick� HCV test for use in the professional market. The
application sought approval for use of the product with multiple
specimen types, including venous whole blood, fingerstick whole
blood, oral fluid and other sample types. The clinical study data
submitted in the PMA showed a high degree of correlation to the
comparator assay conducted at a central laboratory.
Since filing its PMA, the Company has been in frequent
communications with the FDA and has received a number of questions
and requests for additional information from the agency. During its
review of the PMA, the FDA indicated that the Company�s clinical
data could potentially have been affected by bias because the same
operators performed the test and interpreted the results on
multiple specimen types derived from the same patient. The FDA had
previously reviewed and concurred with the Company�s original
clinical trial protocol, which had stated that the study would not
be blinded to prevent an operator from seeing the results of
multiple devices used on the same patient, but would be blinded as
to central laboratory results using an FDA-approved comparator
assay.
When the agency later raised concerns during the PMA review
regarding potential interpretation bias, the Company reasonably
expected to be able to address these concerns without material
impact to the clinical program because the Company had executed the
clinical program as designed. However, the FDA recently concluded
that additional clinical testing will be required to obtain
approval of the PMA for a venous whole blood claim, and that a new
clinical study will be required for approval of claims for oral
fluid and other sample types.
Although the Company believes the clinical data originally
submitted to the FDA is sufficient to support approval of its PMA,
the Company has agreed to conduct the additional clinical testing
and study mandated by the FDA in order to obtain approved claims
for oral fluid, venous whole blood, and fingerstick whole blood.
The exact timing and costs associated with this work will not be
fully determined until after protocols are submitted and reviewed
by the FDA, which should occur in the next several weeks. The
Company expects first to complete the additional testing required
for a venous whole blood claim and submit that data to the FDA for
review and approval, while the additional study for the other
specimen types is completed. The Company believes that it has
adequately responded to all other questions and requests for
information received to date from the FDA with respect to the
OraQuick� HCV PMA submission.
The Company also plans to submit its application for CE mark for
the OraQuick� HCV test shortly. A CE mark is required in order to
sell the product in Europe.
The Company expects to record a non-cash impairment charge of
$3.0 million related to a portion of the milestone payments
previously made under a license for certain HCV patents. These
milestone payments were initially recorded as capital assets. The
Company believes that, in light of the absence of sales in the
international marketplace of a rapid HCV test that is subject to
that license, coupled with expected delays in FDA approval of the
Company�s OraQuick� HCV test as described above, such a non-cash
charge should be taken. The charge is expected to be reflected in
the financial results for the second quarter as an operating
expense and was not previously included in the Company�s financial
guidance for this period.
OraQuick� HIV OTC Test
In August 2008, the Company submitted the results of its
observed use study to the FDA as part of its efforts to obtain
approval for an OraQuick� rapid HIV OTC test. The observed use
study was designed to assess an individual�s ability to interact
with the product packaging, comprehend the instructions for use,
take the test and interpret the results while a trained
professional observed those activities. The observed use study was
stopped after testing was completed for the first 1,000 subjects,
because data from the study met the success criteria initially
established in the study protocol for this phase of the trials.
The FDA recently reviewed the data from the observed use study
at a meeting of its senior management. Following this meeting, the
FDA contacted the Company and indicated that both the results of
the observed use study and the Company�s remaining clinical
activities should also be reviewed and approved by the Blood
Products Advisory Committee (�BPAC�), an advisory committee to the
FDA, before proceeding.
The Company will meet with the FDA to discuss plans for the
upcoming BPAC meeting. The Company intends to gain alignment with
the FDA on the next steps required to complete and file a PMA
application, before presenting a proposal at the BPAC�s meeting
scheduled for November 2009.
OraQuick ADVANCE� HIV Manufacturing
The Company recently has been experiencing an intermittent
difficulty in manufacturing a component required for its OraQuick
ADVANCE� Rapid HIV-1/2 Antibody Test that meets the Company�s
internal quality requirements. This issue initially resulted in
lower production yields, but the Company was able to manufacture
sufficient product to meet existing customer demand. More recently,
however, the Company has experienced additional difficulty in
manufacturing this component. A multi-functional team has been
working aggressively with the assistance of outside consultants to
resolve this manufacturing issue. Because this issue has not yet
been satisfactorily resolved, inventory levels have been reduced
and the Company has been allocating available product among its
customers. In addition, until this issue is satisfactorily
resolved, the Company will be assisting customers in meeting their
HIV testing needs.
The Company�s priority has been and continues to be to provide
the highest quality product to its customers in compliance with all
applicable legal and regulatory requirements. Only OraQuick
ADVANCE� devices that meet the Company�s stringent quality
standards have been and will be released into the field.
If the Company is unable to resume full-scale production of its
OraQuick� HIV test this week, its revenues for the second quarter
of 2009 will be negatively impacted. In addition, in view of the
foregoing, the Company expects gross margin for the second quarter
to be negatively impacted due primarily to higher unabsorbed
production costs and scrap expenses.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral
fluid specimen collection devices using proprietary oral fluid
technologies, diagnostic products including immunoassays and other
in vitro diagnostic tests, and other medical devices. These
products are sold in the United States as well as internationally
to various clinical laboratories, hospitals, clinics,
community-based organizations and other public health
organizations, distributors, government agencies, physicians�
offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid
collection devices to the life insurance industry and public health
markets for the detection of antibodies to HIV. In addition, the
Company supplies oral-fluid testing solutions for drugs of abuse
testing. For more information on the Company, please go to
www.orasure.com.
Important Information
This press release contains certain forward-looking statements,
including with respect to revenues, expenses, products, clinical
testing and regulatory filings. Actual results could be
significantly different. Factors that could affect results include
the ability to market and sell products, whether through an
internal, direct sales force or third parties; ability to
manufacture products in accordance with applicable specifications,
performance standards and quality requirements; changes in
relationships, including disputes or disagreements, with strategic
partners and reliance on strategic partners for the performance of
critical activities under collaborative arrangements; failure of
distributors or other customers to meet purchase forecasts or
minimum purchase requirements for the Company�s products; impact of
replacing distributors and success of direct sales efforts;
inventory levels at distributors and other customers; impact of
competitors, competing products and technology changes; ability to
develop, commercialize and market new products; market acceptance
of oral fluid testing or other products; changes in market
acceptance of products based on product performance and extended
shelf life; continued bulk purchases by customers, including
governmental agencies, and the ability to fully deploy those
purchases in a timely manner; ability to fund research and
development and other products and operations; ability to obtain
and maintain new or existing product distribution channels;
reliance on sole supply sources for critical product components;
availability of related products produced by third parties or
products required for use of our products; ability to obtain, and
timing and cost of obtaining, necessary regulatory approvals for
new products or new indications or applications for existing
products; ability to comply with applicable regulatory
requirements; history of losses and ability to achieve sustained
profitability and ability to utilize net operating loss
carryforwards or other deferred tax assets; volatility of the
Company�s stock price; uncertainty relating to patent protection
and potential patent infringement claims; uncertainty and costs of
litigation relating to patents and other intellectual property;
availability of licenses to patents or other technology; ability to
enter into international manufacturing agreements; obstacles to
international marketing and manufacturing of products; ability to
sell products internationally, including changes in international
funding sources; loss or impairment of sources of capital; ability
to meet financial covenants in agreements with financial
institutions; ability to retain qualified personnel; exposure to
patent infringement, product liability, and other types of
litigation; changes in international, federal or state laws and
regulations; customer consolidations and inventory practices;
equipment failures and ability to obtain needed raw materials and
components; the impact of terrorist attacks and civil unrest;
ability to identify, complete and realize the full benefits of
potential acquisitions; and general political, business and
economic conditions. These and other factors are discussed more
fully in the Securities and Exchange Commission (�SEC�) filings of
OraSure Technologies, including its registration statements, its
Annual Report on Form 10-K for the year ended December 31, 2008,
its Quarterly Reports on Form 10-Q, and its other filings with the
SEC. Although forward-looking statements help to provide complete
information about future prospects, readers should keep in mind
that forward-looking statements may not be reliable. The
forward-looking statements are made as of the date of this press
release and OraSure Technologies undertakes no duty to update these
statements.
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