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Mizuho Survey Finds Strong Uptake of MDx in Prenatal, Women's Health Test Markets

NEW YORK (GenomeWeb News) – Molecular diagnostics is gaining traction among clinicians and were the second-most popular type of test performed in the second quarter, according to a survey released today by investment bank Mizuho Securities.

In the survey of 262 physicians and laboratory personnel for clues about trends in clinical labs, Mizuho found that molecular testing made up 25 percent of all tests performed during the second quarter of this year, trailing only immunochemical tests, which made up 36 percent of all test conducted.

Other types of tests included other (12 percent), healthcare-associated infections (9 percent), cellular (9 percent), cytology (5 percent), and human papillomavirus (4 percent).

In addition, molecular testing volume grew the most during the second quarter, up 3 percent compared to the first quarter of the year. In a report discussing the survey, analyst Peter Lawson called the quarter-over-quarter growth in molecular testing a positive for Cepheid, Gen-Probe, which is being acquired by Hologic, and Qiagen.

In the third quarter, though, healthcare-associated infection and point-of-care tests are expected to see the highest growth, up 2 percent sequentially, which should benefit Cepheid, Becton Dickinson, and Alere, he said.

The survey, which consisted of about 30 questions, focused on trisomy testing and women's health. For the former, respondents were most familiar with Sequenom, which wasn't surprising given its first-mover status. The San Diego-based company launched its MaterniT21 Plus test in October.

Its test was also cited as the molecular-based trisomy test most likely to be used during the next six months "by a wide margin," Lawson said. But with new tests already on the market, or about to hit the market, from companies such as Verinata Health, Ariosa Diagnostics, Natera, and Lifecodexx, the longer-term view for Sequenom is cloudier, he noted.

Overall, respondents performed or referred invasive testing methods, such as amniocentesis, on a larger basis than molecular-based trisomy testing, 33 percent vs. 24 percent, but Lawson said, molecular testing shows "strong uptake."

Among vendors that provide prenatal testing, Genzyme Genetics, now part of Laboratory Company of America, was rated the best-in-class, followed by PerkinElmer's NTD Labs and Sequenom, which tied for second.

The survey also asked clinicians about their HPV and cervical testing habits and found positive trends for genotyping: 43 percent of HPV volumes were genotyped, respondent said, which was higher than expected, according to Lawson. Respondents added that in five years, they expect to genotype 57 percent of HPV volumes.

In addition to a trend toward genotyping, respondents noted a desire for faster testing for HPV and chlamydia/gonorrhea, and in settings where a physician would have control over testing. More than 70 percent of respondents said they would offer a point-of-care test for HPV, CT/GC if such a test were available.

In cervical cancer screening, the survey found that the interval after negative results lengthened to 2.4 years from 2.2 years a year ago. Physicians said they also believe the interval will hit 3 years within the next 1.7 years, which is down from 2.5 years observed in an earlier Mizuho survey.

Lawson said that BD, Hologic, and Qiagen have reported increased intervals, as well, indicating a maturing market.

Lastly, Mizuho asked physicians about their spending habits during the next year and found that Illumina remains the vendor most likely to benefit from any increase in spending. PerkinElmer, Thermo Fisher Scientific, and Agilent Technologies had better results compared to the past four quarters, Lawson said, while Gen-Probe had the largest decline, which he attributed to its pending sale to Hologic.

The survey was conducted between June 18 and July 9. About 58 percent of the 262 individuals who were surveyed completed each question. About 40 percent of respondents were physicians and pathologists, 33 percent were scientists, and 14 percent were lab directors or managers.

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