University of Chicago Clinical Trial Utilizes Sysmex Inostics Highly Effective HPV-SEQ Test to Measure HPV-DNA from Blood of Neck and Throat Cancer Patients

Baltimore, MD (ots) - Sysmex Inostics, a global leader in the liquid biopsy
revolution for oncology, announces the use of their HPV-SEQ test in the
prospective University of Chicago clinical trial,1 "Pilot Study of Chemotherapy
for HPV-Associated Oropharyngeal Cancer."

"The ability to reliably detect HPV-DNA in plasma at such low frequency shows
HPV-SEQ could be a promising non-invasive biomarker test for effectively
assessing treatment response, appropriately de-intensifying treatment using
real-time dynamic HPV quantification, and monitoring HPV-positive OPC patients'
post-treatment," said Dr. Nishant Agrawal, Professor of Surgery at the
University of Chicago. "Therefore, the HPV-SEQ test has the potential to be an
important tool for oncologists in treating patients with HPV-associated head and
neck cancer," he concluded.

Current standard therapy used to treat OPC patients is associated with acute and
long-term toxicities from chemotherapy, radiation, and surgery.2 In the trial,
Dr. Agrawal and team will dynamically assess the level of cfHPV-DNA in patients'
blood and use this information to de-intensify treatment which would improve
therapeutic outcome while minimizing treatment associated toxicity.

Sysmex Inostics senior director of medical affairs, Fred Jones, noted, "The
University of Chicago trial is a strong step forward in showing the clinical
utility of HPV-SEQ test as a tool in treating patients with HPV-associated head
and neck cancer. We look forward to the results of the trial."

HPV associated OPC has increased dramatically over the last decade. In the
United States HPV is thought to cause 70% of oropharyngeal cancers, back of the
throat, including the base of the tongue and tonsils.3

Approximately 10 percent of men and 3.6 percent of women in the U.S. have HPV in
their mouths and HPV infection is more commonly found with older age. While most
people clear the infections on their own within a year or two, in some people
HPV infection persists.4 Patients with HPV-driven disease respond better to
treatment and demonstrate a more favorable prognosis, compared to patients with
HPV negative head and neck cancer.

HPV-SEQ, Sysmex Inostics ultra-sensitive quantitative, CLIA-validated, blood
test for the detection of cell-free HPV 16/18 DNA (cfHPV-DNA), will be used in
the trial to monitor personalized treatment and de-escalation of HPV positive
oropharyngeal cancer (OPC) patients. HPV-SEQ, which can detect as few as 5 HPV
16/18 molecules in a background of 20,000 wild-type molecules (0.025% allele
frequency), empowers this ground-breaking trial. The protocol was published in