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Monogram Biosciences Introduces New Co-Receptor Tropism Assay, Trofile, Access Program
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August 20, 2007
Dear Friends,
On August 6, 2007, the FDA approved Selzentry (maraviroc), the first in a new oral class of HIV medicines in more than ten years. This important new approach to treating HIV stops the virus before it enters uninfected CD4 cells by blocking the CCR5 co-receptor, one of two viral entry points.
The FDA points out several important considerations in Selzentry's indication label:
- Selzentry has been approved for use in combination with other antiretroviral agents for treatment-experienced adult patients who have HIV-1 strains resistant to multiple antiretroviral agents
- Selzentry is indicated for patients infected with CCR5-tropic HIV-1
- The drug's antiviral efficacy has not been demonstrated in patients with dual/mixed or CXCR4-tropic HIV-1
- Tropism testing and treatment history should guide the use of Selzentry
With Selzentry's approval, Monogram has launched our latest HIV diagnostic, the Trofile co-receptor tropism assay. Trofile is a highly accurate patient-selection tropism assay that determines which co-receptor an individual's HIV strain uses to enter healthy CD4 cells. Trofile was used to select patients for the pivotal trials leading up to maraviroc's approval, and is being used in all clinical trials of CCR5 antagonists currently in development. Trofile is the only co-receptor tropism assay currently available.
Because Trofile is necessary to select which patients should be prescribed Selzentry, access to the assay is paramount. We take very seriously our charge to make Trofile available so that anyone living with HIV will have the ability to determine whether they are a candidate for Selzentry.
To that end, we have been working directly with insurers and payors to provide reimbursement as quickly as possible. Because this technology is so new, many insurance plans are in the process of setting new policies in order to cover the test. Monogram will work with each patient regarding coverage and reimbursement. For those without insurance, there are multiple programs in place in order to help gain access to Monogram's assays. Information is available through Monogram's Gateway Line at 1-877-436-6243.
Trofile results are reported to the treating physician, and typically take about 14 days from the date Monogram receives a patient's blood sample. Trofile does not replace other laboratory tests. Because Selzentry is to be used in combination with other antiretroviral agents, Trofile's results should be used in conjunction with those of other tests to evaluate an optimized background therapy.
Trofile is now accessible in advance of Selzentry's availability in the pharmacy, so those patients who are good candidates for Selzentry can begin treatment as soon as possible. Trofile can be ordered directly through Monogram Biosciences at a list price of $1,960. Coverage for molecular tests can take time. Monogram will work with all physicians and patients and take receipt of patient samples as we work with each payor to determine coverage and reimbursement. We understand the need for broad access in HIV care and believe our sample collection and billing model meets the concerns of all patients.
We will have more information about Trofile and its use coming your way shortly as well as online at: www.trofileassay.com. Provided there is strong enough interest within the community, we will be hosting a virtual tropism meeting for HIV treatment advocates, allowing you to remotely log on, ask questions and learn more about Trofile, HIV tropism, and what they mean for those living with and treating HIV. If you have any questions in the meantime, please don't hesitate to contact our Virology team at 1-800-777-0177.
Yours truly,
William Young
CEO, Monogram Biosciences
About Trofile
Trofile is a patient selection co-receptor tropism assay that determines which co-receptor a patient's HIV strain or strains use for viral entry- CCR5, CXCR4, or a combination of CCR5 and CXCR4. These "cellular gateways" that a particular HIV strain uses to gain entry into a healthy CD4+ cell is known as the patients "tropism". Trofile amplifies a patient's HIV genome (from their blood sample) to make HIV particles specific to that individual patient. The resultant HIV particles are then used to infect CCR5- and CXCR4-expressing cell lines. Once the virus infects the cell and undergoes its single round of replication, a reporter gene expresses its indicator gene (luciferase), giving a visible signal-thus identifying the patient's viral tropism. Viral load must be at least 1000 copies/mL to determine a patient's viral tropism.
About Monogram Biosciences, Inc.
Monogram is advancing individualized medicine by discovering, developing and marketing innovative products to guide and improve treatment of serious infectious diseases and cancer. The Company's products are designed to help doctors optimize treatment regimens for their patients that lead to better outcomes and reduced costs. The Company's technology is also being used by numerous biopharmaceutical companies to develop new and improved antiviral therapeutics and vaccines as well as targeted cancer therapeutics. More information about the Company and its technology can be found on its web site at www.monogrambio.com.
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