Cepheid, Others Look Beyond Respiratory Infections in the Molecular POC Diagnostics Market

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Companies looking beyond the clinical lab in the molecular diagnostics market predominately target rapid test demand in primary care and critical care, chiefly respiratory infections. All CLIA waivers to date for molecular tests have been for respiratory infections (influenza, strep A, RSV), though equally ample and more promising markets for molecular point-of-care (POC) diagnostics market will be found in other areas - including women’s health/sexual health and high-burden diseases in the developing world. In its most recent earnings call for the first quarter of 2016, Cepheid referenced this conclusion of Kalorama Information in its recent report, The Market and Potential for Molecular Point of Care Diagnostics, in announcing its revised short-term market strategy for molecular POC diagnostics. Kalorama’s view, that women’s health testing stands to develop by 2020 into a greater molecular POC market than respiratory infections, resonated with Cepheid as its distributors had also begun to report strong interest at the POC level for associated tests.

Kalorama’s view, that women’s health testing stands to develop by 2020 into a greater molecular POC market than respiratory infections, resonated with Cepheid as its distributors had also begun to report strong interest at the POC level for associated tests.

All CLIA-waived molecular tests currently available in the U.S. market are for either influenza or strep A, and the market segment is set to grow even more crowded as most prospective platforms are lead by respiratory assays. Alere (Abbott) and Roche have already begun to sell CLIA-waived molecular tests on their respective Alere i and cobas Liat platforms; Cepheid expects to begin sales of its CLIA-waived GeneXpert Xpress flu-respiratory syncytial virus (RSV) test in the 2017 flu season. Several vendors, including Biocartis and Enigma plan to start their platforms’ CLIA-waived molecular test menu with respiratory assays. Still more plan to launch molecular flu assays behind the initial assay on their low-complexity molecular systems.

In hospital settings, well-known names could win orders for CLIA-waived molecular flu tests, but differentiation in an increasingly competitive product field will be difficult at the physician office laboratory (POL) and outpatient clinic level. Companies looking to launch efforts in the molecular POC space starting with respiratory infections such as flu will have to confront the market volatility and consolidation already experienced in rapid flu immunoassay tests (RIDTs) and likely to be encountered  by next-generation molecular tests.

In hospital settings, well-known names could win orders for CLIA-waived molecular flu tests, but differentiation in an increasingly competitive product field will be difficult at the physician office laboratory (POL) and outpatient clinic level.

In its earnings call for the first quarter of 2016, Cepheid noted the consistency in feedback from distributors and a conclusion of Kalorama Information’s latest report on molecular POC diagnostics regarding the strong market potential for molecular POC tests in women’s health and sexual health. In particular, CLIA-waived molecular Chlamydia/gonorrhea (CT/NG) assays were reported to be of strong interest among customers of Cepheid’s physician office lab (POL)/POC distributors. Kalorama Information projects CT/NG as a leading product market in molecular POC diagnostics in terms of realized sales and potential market volume in 2020. Notable entrants into the U.S. molecular POC diagnostics market Atlas Genetics and Xagenic are also targeting CT/NG testing through their first clinical market assays expected on the market by 2017.

Kalorama Information projects CT/NG as a leading product market in molecular POC diagnostics in terms of realized sales and potential market volume in 2020.

Investors were dismayed by Cepheid’s other announcement with its first quarter 2016 results: the launch of the Cepheid GeneXpert Omni will be delayed into 2017 to ensure the portability and accurate performance of all GeneXpert tests in the instrument’s I-CORE amplification-detection component. The initial planned menu for the GeneXpert Omni in HIV, tuberculosis (TB) and Ebola targets the developing world, where markets are very cost-sensitive and may not be widely receptive to molecular POC tests until 2017-2018. Interim target markets for Cepheid in molecular POC women’s health and sexual health testing are ultimately more appropriate through 2017-2018 given currently available demand in the developed world and the cost efficiency of rapid molecular tests such as CT/NG in clinical settings.

Interim target markets for Cepheid in molecular POC women’s health and sexual health testing are ultimately more appropriate through 2017-2018 given currently available demand in the developed world and the cost efficiency of rapid molecular tests such as CT/NG in clinical settings.

Kalorama Information’s The Market and Potential for Molecular Point of Care Diagnostics provides the current market, projected future sales and total available markets in 2020 for molecular POC diagnostics for flu, strep A, RSV, CT/NG, group B strep (GBS), HPV, HSV, vaginitis, HIV, TB, hepatitis, malaria and many other disease areas.