Pap Smear Cytopathologists Should Review DNA Sequencing for HPV Genotyping like Cardiologists use EKG to Ensure Diagnostic Accuracy, Says Noted Pathologist

HARTFORD, Conn.–(BUSINESS WIRE)–Internationally recognized American pathologist Sin Hang Lee, MD, in a
recent keynote address told conference attendees that Pap smear
cytopathologists should review DNA sequencing for HPV genotyping “in a
similar way that cardiologists use EKG.” Doing so, he said, would result
in a “revolutionary improvement in increased diagnostic accuracy for
physicians and patients.”

Pap smear cytopathologists must begin practicing evidence-based medicine
for cervical cancer prevention in this era of molecular personalized
medicine, Dr. Lee said in a speech entitled “Turn Cytopathology’s Crisis
into Opportunity” at the International Cytopathology Conference in
Toronto on August 31, 2015.

Dr. Lee told attendees that each positive human papillomavirus (HPV)
test report should be accompanied by a signature DNA sequence fully
matched with a GenBank standard sequence as the physical evidence, “like
the EKG in a cardiologist’s report,” to confirm the genotype of the
virus detected. DNA sequencing is the gold standard for HPV genotyping.

Only persistent infection evidenced by finding the same HPV genotype in
repeated cervical samples is associated with cancer risk. However, said
Dr. Lee, an extremely sensitive HPV test is needed to reduce the chance
of false negative results if an HPV test is relied upon for cervical
cancer detection. The PowerPoint slides of Dr. Lee’s presentation are
posted for public viewing on the website of Milford Molecular

Dr. Lee also advised that when a Pap smear shows a high-grade squamous
intraepithelial lesion (HSIL), the report must contain a copy of the
microphotograph image of the premalignant cells as physical evidence
based on which a cytopathologist’s diagnosis is made because Pap smear
cytology classification is highly subjective and not always reproducible.

Cytopathology is a profession created to implement Pap smear as a
screening tool for cervical cancer prevention with great success. But
DNA testing is found to be much more sensitive in detecting HPV
infection, a necessary factor in the pathologic process which may lead
to cervical cancer development in a very small fraction of HPV-infected
patients. Most HPV infections are cleared spontaneously within one year.
Referring all one-time HPV-positive women without Pap smear cytology to
colposcopic biopsy is causing too many unnecessary, traumatic and
harmful procedures on women at great cost to society, said Dr. Lee.

“Pap smear cytology is more accurate in distinguishing a premalignant or
malignant process from other benign conditions and cannot be replaced by
HPV tests as suggested by some experts working as consultants to the HPV
industry,” said Dr. Lee.

Dr. Lee is the director of Milford Molecular Diagnostics laboratory. He
has developed the extremely sensitive and reliable DNA sequencing-based
HPV genotyping tests for cervical screening. This technology is now
being used for molecular diagnosis of Lyme disease and related
borreliosis. The website is


For Milford Medical Diagnostic Laboratory:
Kevin Moore, 203-788-8497