CHICAGO Among the 600-plus companies exhibiting at the American Association for Clinical Chemistry's (AACC; Washington) annual meeting at McCormick Place last 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 Diagnostics & Imaging Week. 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%," he said.

"It[s 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) HPV test for the human papillomavirus 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," Gombrick 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 "fractional histological 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.

Millipore (Billerica, Massachusetts), a provider of solutions to clinical labs and a wide range of other products, showed off a newly released product on the McCormick Place exhibit floor.

At the meeting, Millipore reported what it called the first laboratory water purification system for the clinical diagnostic market that removes alkaline phosphatase, Mikael Cleverstam, worldwide clinical and OEM business manager, told D&IW.

"By using an Elix Clinical system with a BioPak final filter, clinical chemists and analyzer operators can obtain significantly higher levels of performance for immunoassays," the company said. "The proliferation of bacterial species in pure water can create interferences because of bacterial ALP released."

Millipore said that compared with standard clinical feedwater sources, the combination of the BioPark filter on an Elix Clinical system effectively removes ALP from purified water. The company said that ALP has been identified as a "key contaminant" in clinical laboratories which interferes with clinical assays, resulting in a higher risk of "poor or inconsistent test results" leading to "increased costs" and "labor inefficiencies."

"This ultrafiltration method stabilizes baselines and reduces the frequency of calibrations," which in turn, the company said, is designed to increase efficiency and reduce downtime. "For the medical technologist, this decreases sanitation costs that generate more stabilized assay results."

The BioPak filter should be replaced about every three months, Cleverstam said.

Millipore said other clinical products may soon include the BioPak filter for improved performance.

The company in mid-July completed its acquisition of Serologicals (Norcross, Georgia), a move that it said "extends Millipore's core life sciences capabilities into new high-growth market segments." The companies' boards approved the acquisition in April.

Included in the combined company's portfolio of products and services will be an "expanded stronghold" in drug discovery products and services, antibodies, cell biology reagents and stem cell research. It also will have an "increased presence and process expertise in monoclonals and recombinant proteins," Millipore said.

As a result of the acquisition, Millipore will have 5,800 employees worldwide with two primary operating divisions: Bioscience and Bioprocess, creating a $1.4 billion company focused on life science tools.

Millipore also provides solutions to laboratories operating in the area of pharmaceuticals, academia and government research laboratories.

In other news from the AACC meeting:

Abbott Molecular (Des Plaines, Illinois) previewed its new automated molecular diagnostics system, the m2000, which is based on real-time PCR technology for detecting and monitoring infectious diseases. The m2000 system is pending 510(k) clearance. Abbott said it also has submitted a premarket approval application to the FDA for a viral load test for HIV-1 for use on the system.

ARUP Laboratories (Salt Lake City), a national clinical and anatomic pathology reference laboratory, said it has entered into a services agreement with Mednet Services, a laboratory network and billing services information technology company in order to expand ARUP's menu of services available to regional and local hospital-affiliated laboratories in the areas of direct and network-based outreach services.

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.

PerkinElmer (Boston) reported that it has entered into two multi-year 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, told 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.

Protedyne (Windsor, Connecticut), a designer of industrial automation, said that it has integrated its new Radius benchtop robotic system with Roche Diagnostics' (Indianapolis) LightCycler 480 Real-Time PCR System to create an automated high-throughput solution for real-time polymerase chain reaction assays.

Protedyne's Radius is a new benchtop robotic system using the "principles of industrial automation" and designed to offer a high level of flexibility, reproducibility and process control for busy laboratories.