Proteogenix is a corporation based in Portland, Oregon, United States, that develops and markets biomarker diagnostic tests for the detection of life-threatening pregnancy-related conditions. Proteogenix is currently developing non-invasive protein biomarker screening tests for intra-amniotic infection, premature birth, and Down syndrome, which combined cause 175,000 premature births each year in the United States alone.[1]
Miscarriage is the primary risk associated with PUBS and occurs in 1-2% of procedures. Additional possible complications are similar to those for amniocentesis and include blood loss at the puncture site, infection, and premature rupture of membranes. During the procedure, the mother may feel discomfort similar to a menstrual cramp.
PUBS is similar to amniocentesis, but instead of sampling the amniotic fluid which surrounds the fetus, PUBS examines fetal blood. An advanced imaging ultrasound determined the location for needle insertion into the placenta, and the needle is guided through the mother’s abdomen and uterine wall into the fetal vein of the umbilical cord, where a fetal blood sample is removed. The sample can then be sent for chromosomal analysis. The entire process lasts 45 minutes to an hour. Because the fetal vein is fragile early in pregnancy, PUBS is performed no earlier than 17 weeks into pregnancy.
PUBS testing has a turnaround time of about 72 hours and can detect chromosomal abnormalities, blood disorder, some metabolic disorders, infections, and some causes of structural problems.[1] PUBS has largely replaced fetoscopy, which has a much higher rate of miscarriage.
Percutaneous umbilical cord blood sampling (PUBS), also called cordocentesis, is a diagnostic genetic test that examines blood from the fetal umbilical cord to detect fetal abnormalities. PUBS provides a means of rapid chromosome analysis and is useful when information cannot be obtained through amniocentesis, CVS, or ultrasound (or if the results of these tests were inconclusive). This test carries a significant risk of complication and is typically reserved for pregnancies determined to be at high risk for genetic defect.
Current evidence indicates that diagnostic ultrasound is safe for the unborn child, unlike radiographs, which employ ionizing radiation. However, no randomized controlled trials have been undertaken to test the safety of the technology, and thus ultrasound procedures are generally not done repeatedly unless medically called for.
A 2006 study on mice exposed to ultrasound showed neurological changes in the exposed fetuses. Some of the rodent brain cells failed to migrate to their proper position and remained scattered in incorrect parts of the brain.[6]
It has been shown that Low Intensity Pulsed Ultrasound does have a localized effect on growth in human beings. The 1985 FDA-allowed maximum power of 180 milliwatts per square cm [7] is well under the levels used in theraputic ultrasound, but still higher than the 30-80 milliwatts per square cm range of the Statison V veterinary LIPUS device[8]. LIPUS has been shown to effect tissue growth in as little as 20 minutes of time with repeated daily applications. Adding to the similarity, LIPUS and medical ultrasound both operate in the 1 to 10MHz range.
While the benefits of medical ultrasound probably outweigh any risks, vanity uses such as making 3D ultrasound movies without a doctors order present an obviously unnecessary but unknown risk to a developing fetus. Clinical guidelines produced by the Society of Obstetricians and Gynaecologists of Canada recommend against the non-medical use of fetal ultrasound. [9]
In 1962, after about two years of work, Joseph Holmes, William Wright, and Ralph Meyerdirk developed the first compound contact B-mode scanner. Their work had been supported by U.S. Public Health Services and the University of Colorado. Wright and Meyerdirk left the University to form Physionic Engineering Inc., which launched the first commercial hand-held articulated arm compound contact B-mode scanner in 1963.[5] This was the start of the most popular design in the history of ultrasound scanners.
Obstetric ultrasound has played a significant role in the development of diagnostic ultrasound technology in general. Much of the technological advances in diagnostic ultrasound technology are due to the drive to create better obstetric ultrasound equipment. Acuson Corporation’s pioneering work on the development of Coherent Image Formation helped shape the development of diagnostic ultrasound equipment as a whole.
In some countries, routine pregnancy ultrasound scans are performed to detect developmental defects before birth. This includes checking the status of the limbs and vital organs, as well as (sometimes) specific tests for abnormalities. Some abnormalities detected by ultrasound can be addressed by medical treatment in utero or by perinatal care, though indications of other abnormalities can lead to a decision regarding abortion.
Perhaps the most common such test uses a measurement of the nuchal translucency thickness (”NT-test”, or “Nuchal Scan”). Although 91% of fetuses affected by Down syndrome exhibit this defect, 5% of fetuses flagged by the test are in fact normal.
Ultrasound may also detect fetal organ anomaly. Usually scans for this type of detection are done around 18 to 20 weeks of gestational age.
Obstetric ultrasound has become useful in the assessment of the cervix in women at risk for premature birth. A short cervix preterm is undesirable: At 24 weeks gestation a cervix length of less than 25 mm defines a risk group for preterm birth, further, the shorter the cervix the greater the risk.[3] It also has been helpful to use ultrasonography in women with preterm contractions, as those whose cervix length exceeds 30 mm are unlikely to deliver within the next week.[4]
The sex of the baby can usually be determined by ultrasound at any time after 16 weeks, often at the dating scan around 20 weeks into the pregnancy depending upon the quality of the sonographic machine and skill of the operator. This is also the best time to have an ultrasound done as most infants are the same size at this stage of development. Depending on the skill of the sonographer, ultrasound may suffer from a high rate of false negatives and false positives. This means care has to be taken in interpreting the accuracy of the scan.
Gestational age is usually determined by the date of the woman’s last menstrual period, and assuming ovulation occurred on day fourteen of the menstrual cycle. Sometimes a woman may be uncertain of the date of her last menstrual period, or there may be reason to suspect ovulation occurred significantly earlier or later than the fourteenth day of her cycle. Ultrasound scans offer an alternative method of estimating gestational age. The most accurate measurement for dating is the crown-rump length of the fetus, which can be done between 7 and 13 weeks of gestation. After 13 weeks gestation, the fetal age may be estimated by the biparietal diameter (the diameter of the head) and the length of the femur (the longest bone in the body). Dating is more accurate when done earlier in the pregnancy; if a later scan gives a different estimate of gestational age, the estimated age is not normally changed but rather it is assumed the fetus is not growing at the expected rate.[1]
Not useful for dating, the abdominal circumference of the fetus may also be measured. This gives an estimate of the weight and size of the fetus and is important when doing serial ultrasounds to monitor fetal growth.[1]