News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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UCLA Researchers Develop Lens-Free Smartphone Microscope, Pathologists May Be Able to Take the Clinical Pathology Laboratory Just About Anywhere

In a trial, the lens-free microscope invention from the UCLA California Nano Systems Institute enabled a board-certified pathologist to detect cancers and other cellular abnormalities at 99% accuracy

One of our favorite innovators is at it again, this time with a device that could eventually allow pathologists to use a device coupled with a smartphone to view cancer and other abnormalities at the cellular level.

At UCLA, Professor Aydogan Ozcan, Ph.D. is already well known for having invented attachments that use a smartphone’s camera to create a tiny, lens-free microscope. Now Ozcan, who is the Chancellor’s Professor of Electrical Engineering and Bioengineering at the UCLA Henry Samueli School of Engineering and Applied Science, has created an inexpensive smartphone device that produces holographic images of tissue samples that allow pathologists to view cancer and other abnormalities at the cellular level, according to a December 17, 2014, Science Translational Medicine (STM) article. (more…)

Genomic Study Reveals Role of Human Papillomavirus in Cervical Cancer and Identifies Novel Therapeutic Targets for the Disease

Findings may help physicians tailor cervical cancer therapies to specific gene mutations and improve the accuracy of diagnostic screening tests for this disease

New scientific knowledge about the role of human papillomavirus (HPV) in the growth of cervical cancer is creating excitement within the medical community. Among other things, these findings could encourage more widespread vaccination against HPV. That in turn would lead to reduced Pap smear testing by pathology laboratories over time.

For these reasons, cytopathologists and cytotechnologists will be particularly interested in the research findings that were published as a first-ever, international genomic study of cervical cancer, which was published online December 25, 2013, at Nature.com. Researchers discovered that the location where HPV integrates itself into the human genome, is where it causes amplified gene expression that promotes and elevates mutated gene activity that may cause cervical cancer to develop. (more…)

Agreement on Use of Genetic Information from 61-Year-Old Cervical Cancer Cells Sets New Ethical Privacy Standards for Clinical Pathology Laboratories

Family of Henrietta Lacks, who died in 1951, will have a say in the research use of the  HeLA cancer cells

Patient privacy rights involving genetic information has gone to a new level. Pathologists and clinical laboratory managers will want to understand the legal precedents and new standards established in an unprecedented agreement between the family of a woman who died in 1951 and the growing research establishment studying her cervical cancer cells following her death.

It is a human interest story that attracted global media attention this summer. The immortal cancer cells of Henrietta Lacks—known in research laboratories as “HeLA” cells—are finally coming under legal protection after more than 60 years of travelling the globe.

It was 1951 when Lacks died of an aggressive form of cervical cancer, but her cancer cells were grown without consent of relatives and have been used worldwide in cancer research since her death. Lacks’ living relatives sought and recently obtained a legal agreement with the National Institutes of Health (NIH) to protect their DNA privacy, according to a story published in USA Today. (more…)

LabCorp Stops Selling OvaSure Ovarian Cancer Test after FDA Letter

Facing pressure by the Food and Drug Administration over its OvaSure test for ovarian cancer, Laboratory Corporation of America announced last Friday in a Securities and Exchange Commission filing that it had stopped sales of the test. The dispute between the FDA  and the nation’s second largest laboratory company will be closely watched for insights into how the FDA regulates “home brew” assays.

In the October 20, 2008 issue of The Dark Report, an intelligence briefing provides an assessment on the issues of concern to the FDA about the OvaSure test for detection of ovarian cancer. It was these concerns which led the federal agency to send an initial letter and then a warning letter to LabCorp in recent months.

The current troubles swirling around the OvaSure assay represent two unfolding trends in laboratory medicine-and healthcare in general. One is the trend for new healthcare technology to have a demonstrated clinical benefit, along with a reasonable cost to achieve the improvement in clinical outcomes. Two is the repeated statements by the FDA that it sees the need for tighter oversight of diagnostic assays which incorporate molecular technologies.

The first trend came into play shortly after LabCorp, last June, began selling the OvaSure test as one method to detect cervical cancer. A number of physicians quickly criticized this decision. They argued that data from the clinical trials used to evaluate the OvaSure technology was not comprehensive enough to appropriately support how LabCorp recommended that physicians use the OvaSure test to detect cervical cancer. It didn’t take long before certain women’s health advocates also chimed in with criticism of LabCorp’s marketing of the OvaSure test. These criticisms were similarly rooted in a belief that the data from the clinical studies did not fully support the marketing claims for the test.

As to the second trend, the FDA seems to have noticed these public criticisms. It sent a letter to LabCorp late in the summer describing its concerns. Apparently, the FDA was not satisfied by whatever response was provided by LabCorp, because the agency then sent a warning letter to LabCorp earlier this month. In this correspondence, the FDA again questioned the adequacy of the clinical data used to support the manner in how the OvaSure test is marketed. The federal agency also, in its letters, noted that LabCorp was purchasing components of the test from Yale University and was thus not compliant with aspects of the home brew requirements.

By its actions, LabCorp has obviously decided that the best response to the FDA’s stop letter is to cease sale of the OvaSure test. This story has several chapters yet to come, depending on whether LabCorp wants to pursue its case with vigor and whether the FDA takes additional steps to rein in other home brew assays that many laboratories currently offer in today’s clinical marketplace.

For medical laboratories, there are two useful lessons to draw from the flow of events to date. First, a new laboratory test coming to market will have a much easier time gaining acceptance by physicians and payers if that test has strong clinical data to support its clinical efficacy, as well as its cost effectiveness.

Second, the FDA has once again served notice that it is concerned about home brew assays. This is not auspicious for the nation’s molecular testing laboratories, since any additional regulations will make it tougher for these laboratories to offer “home brew” assays to clinicians. It would also make it tougher for labs to gain additional knowledge about how home brew assays perform in clinical use.

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Is New Cervical Cancer Test Better Than a Pap Smear?

Intense research into cervical cancer detection and treatment has yielded significant progress in the past decade. One common cause of such cancer is the human papillomavirus (HPV). New developments involving HPV have produced thin-layer Pap smears, HPV testing, and HPV vaccines. Now, researchers in Italy are reporting a new twist in HPV screening and detection. In research published in the journal Lancet Oncology, Guglielmo Ronco, a cancer epidemiologist at the Centre for Cancer Prevention in Turin, reported that a new way to test for cervical cancer is more accurate than a pap smear alone and identified more dangerous lesions.

Clinicians can improve the specificity of DNA tests for HPV by testing for the presence of a protein that is over-expressed in cervical cancer cells, the new research shows. The molecular test tends to give more false positives, increasing the number of unneeded referrals for colposcopy, Ronco and colleagues reported online in the journal Lancet Oncology. (Carozzi F, et al “Use of p16-INK4A overexpression to increase the specificity of human papillomavirus testing: a nested substudy of the NTCC randomised controlled trial” Lancet Oncology 2008; DOI: 10.1016/S1470-2045(08)70208-0.)

DNA tests for HPV are more likely to pick up cases of high-grade cervical intraepithelial neoplasia (CIN) than conventional cytology, Ronco and colleagues reported. Since the molecular method gives more false positives, it tends to increase the number of unneeded referrals for colposcopy, Dr. Ronco and colleagues reported. To improve specificity, the researchers considered the cyclin-dependent kinase inhibitor p16-INK4A (p16), which is considered to be a marker of HPV infection, according to a report on the findings at www.medpagetoday.com.

Since only a small percentage of women who have an HPV infection actually develop cancer, the challenge for researchers is to identify those who have the highest risk for developing the disease. By testing for a the presence of P16, the researchers said they had identified a biomarker showing cell changes that indicated whether a woman was likely to have pre-cancerous lesions, Ronco and colleagues reported. “The marker shows there was some sort of disruption by the HPV virus,” Ronco said.

“Our data show that in HPV-positive women, p16-INK4A over-expression is strongly associated with the presence of histologically confirmed CIN2+, suggesting that it actually is a marker of progression,” Dr. Ronco said. “This study supports the application of triage by P16INK4A immunostaining in HPV-positive women,” he added.

Data from the U.S. National Cancer Institute show that an estimated 11,000 women in the United States would be diagnosed with this type of cancer and nearly 4,000 would die from it last year. Cervical cancer strikes nearly half a million women each year worldwide, claiming a quarter of a million lives. Studies show 26% of women aged 14 to 59 will contract HPV.

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