Enzo Biochem: Novel Dx tests and clinical lab power growth
As diagnostic testing takes on increasing importance for savings in healthcare and growth in life sciences, the clinical laboratory holds an increasingly critical position at the intersection where these powerful market trends converge.
Well ahead of the curve, Enzo Biochem (NYSE:ENZ) is a vertically integrated biotechnology company not only developing molecular and genomic assays, but also offering advanced clinical lab services to the demanding greater New York medical community.
A physician by training, the President of Enzo Clinical Labs, Kevin Krenitsky, is firmly rooted within both the scientific teams bringing new diagnostics to market as well as with the physician customers whose adoption of these tests is critical for success.
Kevin Krenitsky, President of Enzo Clinical Labs
Krenitsky told partneringNEWS that while it is still early in the days of the emerging trend toward personalized medicine, new tests are already contributing to the 12% growth his division reported in the recently completed fiscal year.
He expects growth to continue in 2011 and by 2012—considering the wave of diagnostics Enzo now has moving through the regulatory approval process—acceleration in the revenues from these high value, high margin tests.
“Where companion diagnostics and personalized medicine were not much more than conference chatter for many years, from where I sit I can tell you the movement toward these tests is very real and becoming more significant every day,” Krenitsky said.
“Already we are seeing drugs that require a particular result from a diagnostic assay before they can be prescribed. In oncology we are seeing an increasing number of markers that indicate how we can best treat a specific tumor. There are markers that can predict whether a patient will experience specific side effects or whether they will be able to properly metabolize the therapeutic,” remarked Krenitsky. “We are fast approaching the moment when we will no longer be treating every breast cancer as the same breast cancer, or every colorectal cancer as the same tumor type.”
“The significance of this shift in patient care will not be lost on readers of partneringNEWS,” he said, “yet developers of such tests, heavily invested in science and technology, risk losing sight of the steps they need to take to assure the success of their assay with physicians.”
“For all the emphasis on assay development, diagnostics remains a sales and marketing business. If you don’t do that effectively, everything else will be for naught,” he said.
“No matter how interesting your science may be, developers need to understand why it should be adopted clinically,” said Krenitsky.
Issues that a clinical lab needs to confront linked to the sales and marketing of a test are critical.
“Is this test reimbursed? That will always be the first question physicians will ask,” he said.
“But what the doctors really want to know is whether this test is going to play a role in altering their decision about how to treat a patient,” he said.
“These physicians are busy taking care of hundreds of patients across a range of diseases every day and are not always up to date on the new advances in genomic or proteomic science,” he said.
“A successful diagnostic will give physicians answers in a clear and concise way, information that is actionable,” he said.
A test that delivers consistent results that are repeatable and relevant to decision making will build greater physician confidence.
Developers of diagnostics also need to think about client service to make it easy for a physician to order the test, so that the physician understands how the results of that test will come back, what the results of the test are going to look like, and how to interpret those results.
“Physicians will always have questions about the results of a test, especially at the genesis of a new test launch,” said Krenitsky.
“This is where the value of a responsive organization like Enzo Clinical Labs comes into play. Physicians know they can call and that one of our physicians, or Client Service Specialists, will be available to answer their questions,” he said.
“This is a critical value-added service, the ability to discuss with a colleague the interpretation of the results and what it means to determining a course of patient care,” he said.
“This type of diagnostic test is completely different from a companion diagnostic that is linked with an FDA approved drug having an intended use statement and a full set of dosage instructions,” he said.
Today, the early integration at Enzo Biochem of lab services with its division for development of diagnostic assays appears to be nothing less than visionary.
These unique capabilities enable Enzo to capitalize firsthand on its extensive advanced molecular and cytogenetic capabilities and the broader trends in predictive and personalized diagnostics.
Krenitsky said the Clinical Lab division has consistently provided a growth engine with revenues supporting the high risk ventures that have built an enviable portfolio of intellectual property for Enzo technology platforms and products.
“Currently we are heavily invested in the development of novel molecular tests that simply enhance patient care,” he said.
He cites the Colon Sentry™ pre-screening assay for colorectal cancer risk assessment, developed with GeneNews, as a benchmark example for the types of tests Enzo will be advancing.
“It provides physicians with an additional data point about a patient, strong evidence to recommend a colonoscopy, and potentially lead to earlier detection of colorectal cancer,” he explained.
“This powerfully supports the health economic discussion with a potential to save tremendous amounts of money downstream. And it affects a very significant patient population,” he said.
Assays for breast cancer and cervical cancer screening exemplify other products Enzo has developed with partner companies.
With 650 employees, Enzo Biochem has generated revenues in excess of USD 100 million last year leaving an impressive global footprint for its Life Sciences and Therapeutics divisions.
Enzo Clinical Labs remains anchored in the greater New York region, serving medical communities in New Jersey and Eastern Pennsylvania and is now reaping the benefits of an extensive transformation of operations that included expanding facilities and growing its offering of both esoteric and genetic testing.
“The transformation last year from a pure clinical lab to a diagnostics company offering a broader menu of tests remains paramount as to why we are now seeing double digit growth with higher margins,” said Krenitsky.
“We are reaping the first benefits of this business strategy with a growth curve suggesting we can expect even greater advances,” he said.
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