New York State Health Department Approves Hepatitis B Virus Quantitative Clinical Assay
September 24 2019 - 9:00AM
Business Wire
Approval of AmpiProbe® HBV Viral Load Assay
Represents Milestone in Providing Comprehensive Menu of Molecular
Diagnostic Tests for Sexually Transmitted Infections
Continues Company-Wide Commitment to Expand
the Market in Diagnostic Testing
Clear Example of Synergies between Labs and
Life Sciences Divisions
Enzo Biochem, Inc. (NYSE: ENZ) today announced that its wholly
owned subsidiary, Enzo Clinical Labs, Inc. has received New York
State approval for its AmpiProbe® HBV viral load monitoring assay
for Hepatitis B virus (HBV) based on the Enzo assay’s performance
versus an FDA-approved comparator product. This is a significant
step forward for the Company as the approval of this HBV assay
further extends Enzo’s portfolio in the viral load monitoring
market where the company has already received New York State
approval for a viral load monitoring assay for Hepatitis C virus
(HCV) and is currently developing a viral load monitoring assay for
human immunodeficiency virus (HIV). This expands Enzo’s menu,
allowing the Company to provide one of the most comprehensive
panels for sexual transmitted infection (STI) testing which
represent a rapidly growing segment.
This newly approved HBV test will be added to Enzo’s existing
STI proprietary tests being run at Enzo Clinical Labs, which have
replaced those provided by other manufacturers. Apart from being
highly effective and economical, the panel is already generating
significantly improved margins for those STI tests now being
conducted at Enzo’s lab. These low cost, high value panels,
manufactured under the industry gold standard Good Manufacturing
Practices, are forming the basis for Enzo’s strategy of providing
lower cost reference services to other clinical labs. Developed and
manufactured at Enzo Life Sciences, and formatted and validated at
Enzo Clinical Labs, they represent a clear example of the
integrated nature of the Company’s businesses and the value of
their synergies.
Enzo CEO Dr. Elazar Rabbani commented, “With this latest New
York State approval, Enzo continues to successfully execute on its
plan to provide a cost-effective, comprehensive menu of assays and
diagnostic tests addressing the sexually transmitted infections
market for women and men. This market is growing rapidly. We are
positioning ourselves as a market leader in this category and Enzo
will continue to capitalize on our history of innovation as we
focus on this market area for growth.”
This news follows the Company’s recent announcement of New York
State Health Department Approval for Gonorrhea and Chlamydia tests
for Oral and Rectal Specimens, and the announcement that Enzo was
creating a direct to consumer testing business for sexually
transmitted infections (STIs). The Company is also developing an
additional test for HPV testing in multiple sample types.
According to the Centers for Disease Control and Prevention
(CDC), a conservative estimate of the number of persons living with
HBV infection in the United States is 850,000 while the actual
number may be as high as 2.2 million. Although effective
preventative vaccines are available, no curative therapies
presently exist for these chronically infected individuals.
Significantly, chronic infection with HBV can have serious
consequences, including the development of cirrhosis, liver failure
and, ultimately, hepatocellular carcinoma, the most common type of
liver cancer.
HBV is transmissible by contact with infectious blood or body
fluids. One mode of transmission is by percutaneous puncture,
typically as a result of syringe use. Another mode of infection is
transmission from mother to baby. The virus is also readily
transmitted by sexual contact and, according to the CDC, as many as
10-40% of individuals being tested at sexually transmitted disease
clinics have evidence of past or current infection by HBV. The CDC
also reports that the development of chronic HBV infection is
age-related, with 90% of infected infants becoming chronically
infected compared to 2-6% of infected adults becoming chronically
infected.
The CDC has estimated that the total number of sexually
transmitted infections in the United States, including eight common
bacterial and viral STIs, is greater than 100 million and that the
number of new sexually transmitted infections is around 20 million
annually.
About Enzo Biochem
Enzo Biochem is a pioneer in molecular diagnostics, leading the
convergence of clinical laboratories, life sciences and
intellectual property through the development of unique diagnostic
platform technologies that provide numerous advantages over
previous standards. A global company, Enzo Biochem utilizes
cross-functional teams to develop and deploy products, systems and
services that meet the ever-changing and rapidly growing needs of
health care today and into the future. Underpinning Enzo Biochem’s
products and technologies is a broad and deep intellectual property
portfolio, with patent coverage across a number of key enabling
technologies.
Except for historical information, the matters discussed in this
news release may be considered "forward-looking" statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended and Section 21E of the Securities Exchange Act of 1934, as
amended. Such statements include declarations regarding the intent,
belief or current expectations of the Company and its management,
including those related to cash flow, gross margins, revenues, and
expenses which are dependent on a number of factors outside of the
control of the Company including, inter alia, the markets for the
Company’s products and services, costs of goods and services, other
expenses, government regulations, litigation, and general business
conditions. See Risk Factors in the Company’s Form 10-K for the
fiscal year ended July 31, 2018. Investors are cautioned that any
such forward-looking statements are not guarantees of future
performance and involve a number of risks and uncertainties that
could materially affect actual results. The Company disclaims any
obligations to update any forward-looking statement as a result of
developments occurring after the date of this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190924005300/en/
For: Enzo Biochem, Inc. Steve Anreder, 212-532-3232
steven.anreder@anreder.com
or
Michael Wachs, CEOcast, Inc., 212-732-4300
mwachs@ceocast.com
Enzo Biochem (NYSE:ENZ)
Historical Stock Chart
From Mar 2024 to Apr 2024
Enzo Biochem (NYSE:ENZ)
Historical Stock Chart
From Apr 2023 to Apr 2024