By Turna Ray
Myriad Genetics is getting into the companion diagnostics business, and at least one of its Rx/Dx collaborations is with AstraZeneca, company officials told investors last week. Additionally, the company is planning to expand its business into Europe and is strategizing to further penetrate the asymptomatic hereditary cancer market -- the proportion of women who don't have breast, ovarian or colorectal cancers, but have a strong family history of the diseases.
"We're working with pharmaceutical companies on two very exciting classes of drugs -- PARP inhibitors and PTEN inhibitors. And we're looking [to develop] companion diagnostics to these new classes of drugs," Myriad Genetics CEO Peter Meldrum said during the company's investor day last week. "We're working with AstraZeneca on the PARP inhibitors and we're also working on PTEN inhibitors."
According to AstraZeneca's pipeline, the company is investigating the PARP inhibitor olaparib in Phase II studies in breast and ovarian cancer, which are areas of diagnostics expertise for Myriad. New drug application filing dates for olaparib are slated for 2012 in BRCA-mutated breast cancer and in 2014 for serious ovarian cancer.
While not disclosing the specific drugs for which Myriad is developing companion diagnostics, Meldrum noted that if these compounds were to be approved by the US Food and Drug Administration, "that could be a significant benefit for the company in the future."
Although this is the first time Myriad has discussed its Rx/Dx collaboration agreement with AstraZeneca, the drug developer has been actively inking relationships with diagnostics firms in the personalized medicine space. Earlier this year, AstraZeneca announced it was working with Dako to develop companion diagnostic tests for its oncology drugs.
Myriad is also planning to establish a presence in Europe by the end of 2012, according to Meldrum. While he estimated that the European diagnostic market represents about 75 percent of the size of the US market, "today only about 5 percent of our revenues come from Europe," he said, emphasizing that there is significant market opportunities on the other side of the pond.
It is important to note that many European countries operate under a single-payor system, which has significantly different revenue implications for diagnostics firms and means that the company's tests will be subject to cost-effectiveness analysis in order to determine if governments will pay for a particular test.
A Physician's Perspective
Citing the American College of Obstetricians and Gynecologists' updated screening guidelines last year, Meldrum said that the company is planning to heighten marketing of BRACAnalysis testing to breast imaging centers and OBGYN offices.
ACOG last year updated its guidelines to recommend that OBGYNs evaluate patients for their risk of hereditary breast and ovarian cancer and that those who have a familial risk for the diseases should be "referred for further assessment to a clinician with expertise in genetics."
These recommendations present the basis for Myriad's push into the asymptomatic hereditary cancer market. According to the company, given that there are around 13 million men and women in the US at risk for hereditary cancers, Myriad's portfolio of predictive tests, including BRACAnalysis and its Colaris test for hereditary colorectal and uterine cancer, could present a $20 billion market opportunity in a 30-year timeframe.
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Speaking during Myriad's investor day, Richard Frieder, medical director at the Cancer Risk Assessment and Prevention Center of Santa Monica, acknowledged that all patients presenting to his practice are screened for their risk of hereditary breast, ovarian, and colorectal cancer. In 2007, Frieder was recruited by Myriad to join the company's physicians group and he has spoken about incorporating the company's hereditary cancer tests into his practice in medical forums.
Frieder explained that while he's not advocating that all women should be tested on BRACAnalysis and Colaris, they should at least be screened for their risk for breast, ovarian, colorectal, and uterine cancer based on a personal and family history. Frieder noted that out of the 100 patients he sees weekly in his practice, he usually ends up testing "a couple of people" on BRACAnalysis and Colaris.
The practicing OBGYN conducted a study in his own practice, in which he tested 105 patients on BRACAnalysis and Colaris with a family history of breast, ovarian or colorectal/uterine cancer. Of those tested, eight patients were found to have genetic mutations predisposing them to such diseases.
Frieder did not shy away from discussing the $67,000 in annual revenues his practice netted from additional procedures and office visits related to patient testing. Of the 105 patients in his study, 91 decided to visit his practice for a check-up twice a year, rather than coming just for their annual OBGYN visit. "There is additional revenue here," from incorporating hereditary genetic cancer screening into physicians' practices, he acknowledged.
Not screening all patients at OBGYN practices could open physicians up to liability, Frieder warned. He further urged doctors in the primary care setting to genetically counsel their patients themselves.
Frieder's advice to doctors on genetic counseling is in line with Myriad's view on the matter. The company has previously encouraged doctors to do genetic counseling in their own practices, and only refer "complex" cases to outside genetic counselors [see PGx Reporter 02-10-2010].
In Frieder's view, for the most part, primary care doctors deliver the same level of genetic counseling as genetics experts. Furthermore, in his own experience, referring patients to genetics centers often results in the patient not following up with outside counselors, which increases the liability for the primary care physician should patients have a negative test result down the line.
Myriad employs genetics experts who train doctors in conducting genetic counseling in their own practices. However, the company says its counselors do not engage in discussions with patients.
In selling BRACAnalysis, Myriad's 300-person sales team (which could grow in the coming months) is mainly focused on targeting the 50,000 OBGYNs in the US. "We've chosen to deploy a sales force to call on the OBGYN market because it's a relatively concentrated market," Myriad Genetic Laboratories President Mark Capone said during the investor meeting. He added that the 160,000-physician primary care space is a more diffused market, and as such, the company is not using its sales force to market its tests to that group.
"The good news is that ... [for] anybody that falls through the cracks in the primary care setting, there are a couple of places where we can go to access those patients in a very effective way," Capone said. "One is breast imaging centers and the other is in gastrointestinal centers."
Myriad announced earlier this year that it was partnering with Mammography Reporting System to "increase the identification of patients at high risk of hereditary breast cancer." MRS, a provider of breast procedure information systems that services 2,400 mammography centers in the US, claims that approximately 8 million mammogram patients are tracked with its software each year. Under the partnership with MRS, Myriad said that it is hoping for "greater penetration into the asymptomatic market -- women who do not have breast or ovarian cancer but have a family history" [see PGx Reporter 01-10-2010].
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In terms of marketing efforts for its hereditary cancer testing portfolio, which includes both BRACAnalysis and Colaris, Myriad plans to continue promoting the tests through its ongoing direct-to-consumer advertising campaign. Myriad is also engaging in marketing through social networking sites, but company officials did not elaborate on those strategies.
Approximately 8,800 OBGYNs have ordered hereditary cancer testing from Myriad, and the company's sales team has called on 9,000 OBGYNs, officials said.
"What we've been able to show is that when we call on OBGYNs with frequency they are able to integrate hereditary cancer testing into their practice," Capone noted, adding that the company is far from saturating the OBGYN market.
According to Meldrum, the company is working with ACOG on new guidelines for Colaris. "If those new guidelines are adopted, we think that it will drive sales for our Colaris product as well," he said.
Additionally, Myriad is also conducting economic studies with BRACAnalsyis and Colaris to try to show a positive health economic impact from expanding the testing criteria supported by professional societies and testing more people than traditional guidelines suggest.
In addition to BRACAnalysis, Myriad's flagship product, the company's portfolio contains seven other tests, including OnDose to measure exposure to 5-FU and TheraGuide 5-FU, to predict toxicity to chemotherapy; Colaris for hereditary colorectal and uterine cancer; a test for adnomatous polyposis colon cancer syndromes, called Colaris AP; a predictive test for hereditary skin cancer, Melaris; a test to measure the status of the PTEN gene, called Prezeon; and the recently launched Prolaris for prostate cancer recurrence.
Myriad aims to launch at least one new diagnostic product each year. For 2010, in addition to Prolaris, the company is also planning to launch a genetic predisposition test for pancreatic cancer in the fall, company officials said.
Prolaris is a 46-gene prognostic test that quantitatively determines the risk of prostate cancer recurrence in patients who have undergone a prostatectomy [see PGx Reporter 03-03-2010]. With 200,000 men in the US diagnosed with prostate cancer each year, and 80,000 prostatectomies performed, the company is estimating that Prolaris, with a $3,400 price tag, presents a $600 million annual opportunity.
Peter Carroll, deputy director at the Yale Cancer Center, said during the investor update last week that the biomarkers in the 46-gene test could be "game changing" in terms of how prostate cancer recurrence is managed in the US, particularly with regard to improving physicians' ability to differentiate between indolent and progressive prostate cancers.
In Carroll's view, Prolaris could potentially help reduce overtreatment of prostate cancer in the US. If ongoing studies validate the utility of the test, Carroll said he would recommend it to patients presenting to the University of Texas' Cancer Therapy & Research Center.
Myriad also updated its commercialization plans for OnDose, which measures patients' exposure to 5-FU so doctors can more accurately dose colorectal cancer patients on the chemotherapy and reduce toxicities associated with treatment. According to the company, there are approximately 175,000 cancer patients per year that receive 5-FU in the US. The test costs $300 per determination, with doctors typically making between eight and 13 measurements with the test in a six-month course of 5-FU.
OnDose will be studied in a prospective trial slated to begin this quarter, which could provide additional data on the clinical utility of the test. The study will compare outcomes when OnDose testing is used to dose four cycles of chemotherapy versus when body surface area measurements are used to dose therapy.