Clinica Article

(republished with permission: article link: http://www.clinica.co.uk/marketsector/ivds/Arrayit-hopes-to-thwart-silent-killer-with-first-ovarian-cancer-blood-test-186598?autnID=/contentstore/clinica/codex/ed36c0ae-01b9-11df-8bb3-bbf166501cad.xml

Arrayit hopes to thwart "silent killer" with first ovarian cancer blood test

By Madeline Armstrong

January 15, 2010

Ovarian cancer is dubbed the "silent killer" because its unspecific symptoms often mean that patients are diagnosed with late-stage disease with a poor prognosis. Madeleine Armstrong spoke exclusively to Mark Schena, president of Arrayit, a company that is planning to change this with what it hopes will be the first ovarian cancer screening test, OvaDx

Ovarian cancer is the fifth leading cause of cancer death in women and the most deadly gynaecological cancer. It is often diagnosed at an advanced stage, meaning that the prognosis for most patients is grim – the five-year survival rate for late-stage disease is only around 20%. However, if it is diagnosed and treated while in its early stages, this could rise to over 90%.

Currently, only 20% of cases of the disease are diagnosed at an early stage. One of the problems with trying to increase this figure is that ovarian cancer symptoms are unspecific and common in many women without the disease. These include abdominal pain, discomfort or bloating, urinary frequency and abnormal vaginal bleeding.

Currently, there is no diagnostic test to screen for the disease: Vermillion and Quest Diagnostics' OVA1 is used to help determine whether women with a pelvic mass are likely to have ovarian cancer; while LabCorp has stopped selling its blood test OvaSure, which was designed to detect early-stage disease in high-risk women, after being criticised by the US FDA for launching it without regulatory approval (www.clinica.co.uk, November 13 2008).

CA125 is a known biomarker for ovarian cancer, but its use is limited by the fact that it may also be elevated in other cancers and benign conditions such as endometriosis. Its role in the early diagnosis of ovarian cancer is therefore controversial, and it is probably more useful for monitoring patients for recurrence rather than as a screening tool.

Microarray specialist Arrayit plans to remedy this situation with an ovarian cancer blood test, OvaDx, which is in late-stage development. The Sunnyvale, California firm is currently refining the test, and hopes to submit it to the US FDA in the second quarter. Approval could follow by as early as the fourth quarter of 2010. "We hope to get it reviewed on an expedited basis, as there is such an unmet need," Arrayit's president, Mark Schena, told Clinica. The company plans to CE mark the test for sale in Europe after US approval.

OvaDx is different than other available tests because it could be used for screening programmes in the general population, similarly to Pap screening for cervical cancer, which has dramatically reduced mortality from that disease. Like cervical cancer, ovarian cancer is quite easy to treat in its early stages, Dr Schena explained. "The procedure to remove an ovarian mass is relatively noninvasive. It's not quite an outpatient process, but for early-stage disease it's very close to that."

Arrayit hopes that its test could "nip ovarian cancer in the bud". It can detect an ovarian tumour that is around half a centimetre in diameter, Dr Schena said. In comparison, late-stage tumours (stage III/IV) can weigh from half a kilogram to several kilograms.

OvaDx only requires a few drops of blood, so could be added to a regular health check. "We would recommend that high-risk women and those over a certain age be tested annually, while average-risk younger women could be tested every few years," he said. Arrayit is currently looking into the age limit for yearly testing, but thinks the threshold would probably be around 50 years.

The test is based on over 100 protein biomarkers that are upregulated during the body's immune response to a tumour. "The test works by measuring markers produced by the immune system in response to early-stage ovarian cancer," Dr Schena explained.

In studies that have been carried out to date, in up to 1,000 patients, there have been no false-positive results, he said. "There have been several false negatives, but we expect this to be very low once we've refined the test." Although this means there is a slight risk of missing cases of cancer, Dr Schena pointed out that this was better than the current alternative – nothing.

As for the risk that a false positive could lead to unnecessary surgery, he was adamant that this would not be the case: "We would recommend that any positive result with OvaDx be confirmed with another technique such as ultrasound. Until then, patients should not undergo any treatment or surgery." Ultrasound would also help pinpoint the location of the mass and its size to aid surgical procedures.

Arrayit is also working on tests for the early diagnosis of other diseases such as Parkinson's and prostate cancer. But in the meantime it is "very excited about bringing this rather revolutionary ovarian cancer test to the market", Dr Schena said.

It might not be the only one: earlier this month, MabCure started a trial to evaluate monoclonal antibodies in ovarian cancer, which it hopes will be used for early diagnosis (www.clinica.co.uk, January 7). The company did not release many details about its diagnostics, and it appears to be in early-stage development.

Whether either or both tests succeed, it looks like there will soon be a screening test for ovarian cancer – potentially silencing the silent killer.