Medical Device Daily

CHICAGO – Among the 600-plus companies exhibiting at the American Association for Clinical Chemistry 's (AACC; Washington) annual meeting at McCormick Place this week, Diamics (Novato, California) CEO and Chairman Peter Gombrich was not shy about saying that his company has developed “a replacement for the Pap smear.”

The problem with the Pap smear, which has been available for decades, is that it is a “very, very subjective test,” Gombrich told Medical Device Daily. In a meta-analysis of Pap smears completed by Duke University (Durham, North Carolina), he said the specificity can run from as unimpressively as 30% to “as good as 70% to 80%.”

“Its accuracy would depend upon how good the person who is doing the test is – or how they're feeling at the particular time or hour they're doing it,” Gombrich said.

Even Digene 's (Gaithersburg, Maryland) Pap smear, which also tests for the human papillomavirus (HPV), does not tell physicians what they need to know, because “even if you're HPV-positive, it does not mean you're going to get cervical cancer.

“So, if you're negative of HPV, the probability of you [getting cervical cancer] is very, very, very slim, but if you're positive it means nothing,” Gombrich said, noting that in the FDA approval for Digene's HPV test, if it returns with a positive, the FDA requires only that another Pap smear be completed.

Instead, Diamics has developed both a collection device for cervical tissue and its C-Map system, a molecular imaging system. The springloaded device is inserted into the cervix and captures tissue which is then loaded into the C-Map system, maintaining the “integrity of exactly where . . . the sample” came from in the cervix.

That sample Diamics calls a “fractionaly histological sample,” because it “maintains the clusters and clumps” in the sample. The collection device acquires tissue from the endocervical area and the area leading from the vagina to the cervix.

Gombrich said the sample is then read on a fully automated scanner, a process that can take place in either a lab or in a physician's office.

The C-Map device creates a map of where the tissue was collected inside the cervix, so if abnormalities are found, the physician can be redirected to that site for immediate treatment.

“The [system] does anywhere from 40 to 70 slides at one time, and what it does is it looks for dysplasia . . . if there is dysplasia, it gives me a map of exactly where it came from in the cervix,” Gombrich said.

Thus far, the accuracy of the test has been shown to have a sensitivity of 98% and specificity of 90%.

“What we have now is a more accurate test, and what's more is I can do this [at] from one-half to one-third of the cost of the regular Pap smear,” Gombrich said.

The system is now being tested at five sites, including in the U.S., Chile and India. Those trial sites are expected to be completed in the second quarter of 2007, at which point the data will be submitted to the FDA. However, Diamics will begin selling the system outside the U.S. in the second quarter, with the expectation of bringing in revenue that quarter.

In other news at AACC, PerkinElmer (Boston) reported that it has entered into two multiyear research collaborations with Johns Hopkins University (Baltimore) and the University of Birmingham in the UK to establish the groundwork for developing tools and technology for the discovery of biomarkers leading to diagnostics and personalized medicine.

Specifically, the collaboration will be with Daniel Chan at Johns Hopkins and Philip Johnson at the University of Birmingham. Mary Lopez, strategic collaborations leader in molecular medicine, described them to MDD as being on the “cutting edge” of their fields.

The PerkinElmer BioExpressions platform is designed as a solution for high-throughput biomarker discovery and identification. Its carrier protein-based biomarker enrichment technology is a “new method [for] finding low abundance disease-related biomarkers.”

bioMerieux (Durham, North Carolina) reported at AACC the launch of analyte-specific reagents (ASR) for Mycoplasma pneumoniae and Chlamydophila pneumoniae, or chlamydia.

Each NucliSens ASR contains a primer/probe mix designed for individual pathogen amplification and detection using bioMerieux's nucleic acid sequence-based amplification combined with molecular beacon technology.