In accordance to its targeted timeline, Cepheid CPHD recently launched its Xpert BCR-ABL Ultra test commercially outside the U.S. The company will initiate shipment of this test as a CE-IVD product from the ongoing week. The launch successfully reflects Cepheid’s efforts to expand its Xpert test menu in the international markets.
Notably, this quantitative assay allows physicians to thoroughly monitor the efficacy of treating patients suffering from chronic myelogenous leukemia (CML), with tyrosine kinase inhibitors (TKIs).
Interestingly, this news surfaced only a day after Cepheid’s rapid influenza and RSV assay – the Xpert Flu+RSV Xpress test – won the U.S. FDA 510(k) marketing approval and the Clinical Laboratory Improvement Achievements (CLIA) waiver. With the company currently offering a menu of 23 Xpert tests overseas and 18 in the domestic market, this consecutive pair of news reflects significant development in the company’s target to expand the numbers to 41 and 37 respectively by 2017-18.
Mostly found in adults, CML is a type of cancer that causes genetic change in an early version of myeloid cells – which produce red blood cells, platelets, and most types of white blood cells. This genetic transformation generates an abnormal gene called BCR-ABL, which causes myeloid cells to turn into CML cells.
Although CML is a fairly slow-growing cancer, as per American Cancer Society’s estimates, CML cases during 2015 are set to touch about 6,660. Of these, 1,140 patients have life risk.
TKI – a well-known pharmaceutical drug that targets BCR-ABL genes – is used for standard treatment of CML patients. Recent data revealed that for a subset of CML patients with consistently deep molecular response, TKI therapy may be avoided altogether, without the fear of further recurrence of the disease.
Cepheid’s Xpert BCR-ABL Ultra effectively measures the level of this molecular responsiveness in CML patients, thus allowing physicians to determine whether a patient needs further TKI treatment. The commercial availability of this test will boost optimal treatment of CML patients in the international market.
Prior to this, no single test for BCR-ABL had regulatory approval for commercial availability. With Cepheid’s Xpert BCR-ABL Ultra as the first in its league, we expect the company’s test revenues to shoot up considerably, going forward.
Moreover, the launch of Xpert BCR-ABL Ultra is expected to support the mission of the Max Foundation – a global organization aimed at providing oncology care – to allow hematologists to optimize clinical outcomes and patients to maximize their potential.
With the global molecular diagnostics market expected to reach $8.7 billion by 2019, owing to a growing aging population and rise in cancer cases; we expect the launch of Cepheid’s speedy and accurate Xpert BCR-ABL Ultra test to boost the company’s profit line, going ahead.
Currently, Cepheid carries a Zacks Rank #4 (Sell). Some better-ranked medical products stocks are Masimo Corporation MASI, Natus Medical Inc. BABY and Steris Plc STE. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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