The Observatory

Feb. 21, 2017

Cervical Cancer

Is the annual number of cases of cervical cancer worldwide.

Is the annual number of deaths caused by cervical cancer worldwide.

Is the number of cases of cervical cancer in the U.S. each year.

Is the number of deaths caused by cervical cancer in the U.S. each year.

21-65 years
Is the age range for routine Pap smears and cervical cancer screening.

65 years plus
Is the age when screening guidelines state women do not need testing, if they have had three healthy tests over the previous decade.

65 years plus
Is the age many women are dying from cervical cancer.

Is the rate of prevention, cervical cancer is a preventable disease.



NIH to expand critical catalog for genomics research. The National Institutes of Health (NIH) plans to expand its Encyclopedia of DNA Elements (ENCODE) Project, a genomics resource used by many scientists to study human health and disease. Funded by the National Human Genome Research Institute (NHGRI), part of NIH, the ENCODE Project is generating a catalog of all the genes and regulatory elements—the parts of the genome that control whether genes are active or not—in humans and select model organisms. With four years of additional support, NHGRI is building on a longstanding commitment to developing freely available genomics resources available for use by the scientific community.

Since launching in 2003, ENCODE has funded a network of researchers to develop and apply methods for mapping candidate functional elements in the genome, and to analyze the enormous database of generated genomic information. The data and tools generated by ENCODE are organized by two groups: a data coordinating center, which houses the data and provides access to the resource through an open-access portal; and a data analysis center, which synthesizes the data into an encyclopedia for use by the research community.

Pending availability of funds, NHGRI plans to commit up to $31.5 million in fiscal year 2017. With this funding, ENCODE will expand the scope of its efforts to include characterization centers, which will study the biological role that candidate functional elements may play and develop methods to determine how they contribute to gene regulation in a variety of cell types and model systems. Additionally, the project will enhance the ENCODE catalog by developing a way to incorporate data provided by the research community, and it will use biological samples from research participants who have explicitly consented for unrestricted sharing of their genomic data.

New Assays

FDA permits marketing of first newborn screening system for rare metabolic disorders. The FDA has permitted marketing of the Seeker System (Baebies, Inc.) for the screening of four rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed to detect Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher, and Fabry. It is the first newborn screening test  for these disorders to be approved by the FDA for marketing.

LSDs are a group of rare, inherited metabolic disorders in which enzymes (proteins) that normally eliminate unwanted substances in the body’s cells are not at normal levels or functioning properly. According to the U.S. Department of Health and Human Services’ Advisory Committee on Heritable Disorders in Newborns and Children, these disorders occur in approximately 1 in 1,500 to no more than 1 in 185,000 newborns and children, depending on the disorder. If not detected and treated in a timely manner, these disorders may cause organ damage, neurological disability, or death.

Several states currently mandate LSD screening in all newborns. However, until now there were there were no FDA-authorized devices for screening of these disorders. Availability of the Seeker System provides laboratories with a screening tool that has been reviewed by the FDA for clinical and analytical validity.

The Seeker System, consisting of the Seeker LSD Reagent Kit- IDUA|GAA|GBA| GLA and Seeker Instrument, works by measuring the activity level of proteins required for healthy lysosomal storage found in dried blood samples collected from the prick of a newborn’s heel 24 to 48 hours after birth. The Seeker Instrument is a device that automates the analysis of dried blood spots. Reduced enzyme activity of proteins associated with any of the four LSDs detected by the kit may indicate presence of a disorder. Results showing reduced enzyme activity must be confirmed using other testing methods, such as biopsies and genetic and other laboratory tests.

Risks that are associated with use of the screening system include false negative findings.


Research supports expanded use of cell free DNA prenatal testing. A DNA-based prenatal blood test used to screen pregnancies for Down syndrome and similar chromosome abnormalities in high-risk women has moved a step closer to use in the general pregnancy population. Researchers at Women & Infants Hospital of Rhode Island have published a study in Genetics in Medicine that shows that this non-invasive test can be effectively and appropriately offered to all pregnant women, regardless of maternal age or risk factors, through primary obstetrical care providers.

The research, “The clinical utility of DNA-based screening for fetal aneuploidy by primary obstetrical care providers in the general pregnancy population,” was funded by a grant from Natera, Inc., and the DNAFirst test was primarily based on Natera’s Panorama offering.

The study aimed at determining the knowledge and satisfaction of women who chose the DNAFirst screening test as part of routine prenatal care. Of the approximately 2,700 women in Rhode Island who chose screening, a subset with specific test and demographic characteristics was contacted. These women participated in a 15-minute structured telephone interview about their experience.

Infectious Diseases

CDC publishes final rule for control of communicable diseases. The Centers for Disease Control and Prevention (CDC) has published the final rule for the Control of Communicable Diseases, which includes amendments to current domestic (interstate) and foreign quarantine regulations for the control of communicable diseases. These amendments have been made in response to public comments received regarding the notice of proposed rulemaking published on August 15, 2016. This final rule improves the CDC’s ability to protect against the introduction, transmission, and spread of communicable diseases while ensuring due process. This rule became effective on February 21st, 2017.  The final rule is published on the Office of the Federal Register’s website.

HHS/CDC published a Notice of Proposed Rulemaking (NPRM) on August 15, 2016, and received 15,800 public comments from individuals, stakeholders, and other interested parties during the 60-day comment period. These comments covered a range of topics, including concerns regarding agreements between the CDC and persons subject to federal public health orders; forced vaccination or medical treatment; the CDC’s constitutional and statutory authority for carrying out quarantine and isolation; data collection from aircraft and vessel operators; people being quarantined for non-quarantinable illnesses; due process; electronic monitoring and surveillance of persons subject to federal public health orders; the proposed definition and requirement for airline and vessel operators to report an “ill person”; public health risk assessments being made by non-medically trained personnel; payment for hospital and other expenses for persons subject to federal public health orders; and the proposed definition of “indigent.”

The Final Rule:

  • Outlines the provisions to reflect input received from individuals, industry, state and federal partners, public health authorities, and other interested parties.
  • Does not authorize compulsory medical testing, vaccination, or medical treatment without prior informed consent.
  • Requires the CDC to advise individuals subject to medical examinations that such examinations will be conducted by an authorized health worker and with prior informed consent.
  • Includes strong due process protections for individuals subject to public health orders, including a right to counsel for indigent individuals.
  • Does not expand the CDC’s authority beyond what is granted by Congress, nor does it alter the list of diseases subject to federal isolation or quarantine, which is established by an Executive Order of the President.
  • Limits to 72 hours the amount of time that an individual may be apprehended pending the issuance of a federal order for isolation, quarantine, or conditional release.
    Provides the public with explicit information about how and where the CDC conducts public health risk assessments and manages travelers at U.S. ports of entry.

Blood Banking

RFID-enabled blood tracking system now in hospital phase. BloodCenter of Wisconsin has launched a pilot program at Children’s Hospital of Wisconsin using radio frequency identification technology (RFID) to digitally track blood usage and inventory. Children’s Hospital of Wisconsin is the first pediatric hospital in the country to use RFID in the area of transfusion medicine.

The project involves the use of specialized RFID tags applied to blood bags prior to shipment to hospitals. These tags can be tracked automatically as the blood moves through the hospital, and to the point at which it is used to treat patients. This process allows for real-time information designed to help healthcare professionals optimize the availability of their blood supply.

The use of RFID allows for the sharing of blood component inventory data easily and quickly between blood centers and hospitals. The RFID technology electronically tracks the blood from the time it leaves BloodCenter of Wisconsin, to the hospital’s transfusion service area, and on to use of the products. Children’s Hospital and BloodCenter can jointly look at the movement of products to better inform immediate need and inventory status.

BloodCenter of Wisconsin spearheaded the use of RFID technology in non-pediatric transfusion medicine environments in 2006 under a National Institutes of Health grant.

Industry News

AACC partners with NEJM Group to launch AACC Learning Lab. The American Association for Clinical Chemistry (AACC) last month announced the launch of AACC Learning Lab. Developed through a collaboration with NEJM Group—the publisher of the New England Journal of Medicine—and Area9 Learning, Learning Lab is designed to help laboratory medicine experts expand their knowledge and enhance their ability to find answers to challenging patient health problems.

This online learning platform combines laboratory medicine content with adaptive technology used by NEJM Knowledge+ and developed by Area9 Learning. The Learning Lab can be used by those preparing for certification exams and seeking continuing education. Covering all disciplines of laboratory medicine, the material provided by AACC Learning Lab is divided into five program areas: clinical chemistry, hematology and coagulation, transfusion medicine, microbiology, and molecular diagnostics. Each program area consists of approximately 20 courses that address different topics in that discipline and are prepared by distinguished experts, many of whom are AACC members.


Continuous glucose monitoring lowers blood sugar. Significantly decreased blood sugar levels over time—and increased well-being. These are two key results of a long-term study at Sweden’s Sahlgrenska Academy of continuous glucose monitoring in persons with type 1 diabetes.

“This is one of few new treatments in recent decades which significantly reduces blood sugar levels for persons with type 1 diabetes, who are dependent on insulin injections,” notes Marcus Lind, Associate Professor of Diabetology at the department of molecular and clinical medicine.

A total of 161 people took part in the study, each one in need of insulin injections several times per day in order to keep their blood sugar levels in check. They were randomly selected in different rounds either to use traditional equipment, and prick their finger at least four times per day in order to measure the sugar levels, or to use a device which measures the blood sugar continually via a thin filament under the skin on the stomach. A separate unit kept in the pocket would beep or vibrate when the sugar level was too high or too low.

The study lasted 16 months, and the patients used each method over a six-month period, with a four-month “washout period” without assisted treatment between each round. “The principal question was whether there would be a difference in the average blood sugar levels. What we saw was that when patients used this continual blood sugar measurement, they had a lower blood sugar level on average—something which is considered significant in reducing the risk of complications with type 1diabetes,” Lind explains.

The blood sugar value, measured using the marker HbA1c, which gives a mean value over a three-month period, dropped by five millimole per mole, a leap which can be considered justification for giving wider access to the treatment.

Previous studies of the technology have been more focused on the verification, over shorter periods, of blood sugar values produced by continual measurement. The fact that the mean sugar levels have been shown to actually decrease is something that can protect the patient group.

The study also shows an increase in treatment satisfaction and well-being. Those factors are important in themselves, and they also improve the chances of the treatment working in the long term.