Be sure to check official websites, Facebook pages or contact numbers to make sure scheduled events are still happening.
CARDEN CIRCUS:Acrobats, aerialists, animals, daredevils and clowns will be among the performers at the Carden International Circus when it presents five shows Sept. 23-25 at the Pontchartrain Convention & Civic Center, 4545 Williams Blvd., Kenner. Tickets are $10 for children and $25 for adults at www.spectacularcircus.com.
CRAFT FAIR: Archbishop Chapelle High School’s 24th annual craft fair will be held from 9 a.m. to 4 p.m. Sept. 24 on the campus at 8800 Veterans Memorial Blvd., Metairie. With over 300 vendors, it will be the largest to date.
WHITE ELEPHANT SALE: Munholland United Women in Faith will be raising money for its mission partners with a white-elephant sale from 8 a.m. to 1 p. m. Saturday, Sept. 24, at Munholland United Methodist Church, 1201 Metairie Road. Clothing is not part of this sale, but there will be plenty of items for home and yard.
PLANT GIVEAWAYS: Two plant giveaways are coming up.
Keep UNO Beautiful and the Native Plant Initiative of Greater New Orleans will hold a plant giveaway beginning at 9 a.m. Saturday, Oct. 1, at the UNO Administration Building, 6650 Milneburg Road, New Orleans. For more information, contact Carol Lunn at (504) 280-7155 or [email protected]
, To read the original article from www.nola.com, Click here
The U.S. Food and Drug Administration (FDA) is warning patients and health care providers about the risks of false results with genetic non-invasive prenatal screening (NIPS) tests, sometimes called noninvasive prenatal testing or tests (NIPT). Results from NIPS tests can provide information about the possibility of a fetus having certain genetic abnormalities that could result in a child being born with a serious health condition.
While health care providers widely use NIPS tests, none have yet been authorized, cleared, or approved by the FDA. The accuracy and performance of NIPS tests have not been evaluated by the FDA and these tests can give false results, such as reporting a genetic abnormality when the fetus does not actually have one. NIPS tests are screening tests, which means the NIPS test may only tell you the risk of the fetus having certain genetic abnormalities. They are not diagnostic tests, which are generally used to more definitively confirm or rule out a suspected genetic abnormality.
The FDA is aware of reports that patients and health care providers have made critical health care decisions based on results from these screening tests alone and without additional confirmatory testing. Specifically, pregnant people have ended pregnancies based only on the results of NIPS tests. Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test. The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.
Given the increased use of these tests and concerns raised in recent media reports, the FDA is providing this information to educate patients and health care providers and to help reduce the inappropriate use of NIPS tests. The FDA recommends that patients discuss the benefits and risks of NIPS tests with a genetic counselor or other health care provider before deciding to get these tests. Patients should also discuss the results of NIPS tests with a genetic counselor or other health care provider before making any decisions about their pregnancy. Health care providers should be aware of the risks and limitations of using these screening tests and should not use the results from these tests alone to diagnose chromosomal (genetic) abnormalities or disorders.
Recommendations for Patients
Talk with a genetic counselor or other health care provider before deciding to have prenatal testing and to discuss which tests to use, including genetic screening tests such as NIPS tests. Genetic counselors and other health care providers can help you understand the benefits and risks of these tests.
Do not use the results of screening tests such as NIPS tests alone to make decisions about your pregnancy because the results of these tests may not accurately reflect whether your fetus has a genetic abnormality. Additional testing may require invasive procedures to obtain a sample, such as amniocentesis or chorionic villous sampling (CVS), which carry a small risk of miscarriage. The diagnostic confirmatory tests performed on these samples may not have been reviewed by the FDA.
Discuss the results of genetic prenatal screening tests and what the results may mean with a genetic counselor or other health care provider. They can help you decide whether to get additional testing to confirm results from a screening test.
A positive screening test result means that the fetus has a higher risk of having a genetic abnormality compared with the average risk. It does not mean that the fetus definitively has a genetic abnormality, or a condition caused by a genetic abnormality.
A negative screening test result means that the fetus has a lower risk of having a genetic abnormality compared with the average risk. It does not rule out the possibility that the fetus has a genetic abnormality, or a condition caused by a genetic abnormality.
The ability of a NIPS test to correctly tell whether a fetus is at risk for a genetic abnormality depends on how common or rare the genetic abnormality is and on underlying risk factors. Disorders caused by a microdeletion (small missing piece of a chromosome) are rare. Because these conditions are so rare, a positive result may be more likely to be from a healthy fetus than one that actually has the reported genetic abnormality.
Recommendations for Health Care Providers
Review the Recommendations for Patients with your pregnant patients.
In addition to technical issues, multiple biological factors can influence NIPS results. For example, in some cases, a positive NIPS test result may accurately detect a chromosomal abnormality, but that abnormality is in the placenta and not in the fetus. In these cases, the fetus may be healthy. Additional confirmatory diagnostic tests should be performed to determine whether or not the fetus is affected.
Discuss with your patients the benefits and risks of prenatal tests, including genetic screening tests such as NIPS tests.
Do not use the results of screening tests such as NIPS tests alone to diagnose chromosomal abnormalities or disorders.
Ensure your patients receive the appropriate follow-up testing and care, including genetic counseling, as needed.
Test Description and Background
Noninvasive prenatal screening (NIPS) tests analyze small fragments of fetal DNA, called cell-free DNA, that are circulating in a pregnant person’s blood with the goal of determining the risk that the fetus has certain genetic abnormalities. When used appropriately, these tests offer a non-invasive approach for prenatal screening and may provide useful information to assess the risk that a fetus has (or does not have) a genetic abnormality. It is important for patients and health care providers to be aware that these are screening tests, not diagnostic tests, and to understand the benefits, risks, and limitations of these tests.
Many laboratories that offer these tests claim the tests are “reliable” and “highly accurate,” offering “peace of mind” for patients. The FDA is concerned that these claims may not be supported with sound scientific evidence. False claims may cause patients as well as health care providers to believe the test results are reliable and can be used alone to make decisions about the pregnancy. In addition, because some of the genetic abnormalities and disorders are so rare, in cases such as detection of a microdeletion, there may be a high chance that a positive result is actually from a fetus that does not have the genetic abnormality reported by the test.
The NIPS tests currently being offered are marketed as laboratory developed tests (LDTs). Most LDTs, including NIPS tests, are offered without FDA review. While LDTs are medical devices under the Federal Food, Drug, and Cosmetic Act, the FDA has had a general policy of enforcement discretion for most LDTs since the Medical Device Amendments were enacted in 1976. That means that FDA does not generally enforce applicable regulatory requirements for most LDTs. The FDA is continuing to work with Congress on legislation to establish a modern regulatory framework for all tests, including LDTs.
Additional Information for Health Care Providers
The FDA recommends that health care providers also be aware of the positions of relevant professional societies, including the American College of Obstetricians and Gynecologists (ACOG), the Society for Maternal-Fetal Medicine (SMFM), and the American College of Medical Genetics and Genomics (ACMG):
These medical professional societies recommend that prenatal genetic screening should be discussed and offered to all patients regardless of their age or risk for a chromosomal abnormality.
Patient education is emphasized in order to support informed decision making about whether to accept or decline screening. Emphasis is placed on education surrounding the positive predictive value of NIPS tests and the appropriate use of cell-free DNA tests as screening and not diagnostic tests.
ACMG specifically recommends against testing for aneuploidies (missing or extra chromosomes) other than those involving chromosomes related to Down syndrome (21), Edwards syndrome (18) and Patau syndrome (13).
ACOG does not recommend the use of NIPS tests to detect microdeletions.
Published studies also strongly support the importance of performing confirmatory diagnostic testing to determine whether or not the fetus truly has a chromosomal abnormality following a positive screening test result. The scientific literature related to the use of NIPS tests from laboratories, including 25 peer-reviewed publications covering 13 studies evaluating more than 10,000 individuals undergoing NIPS, indicates that the NIPS tests evaluated generally perform well for ruling out disorders caused by chromosomal abnormalities. The scientific literature generally report high negative predictive values, greater than 99.9% when calculated, for the NIPS tests studied. This means that the fetus is very likely not to have a chromosomal abnormality if the test returns a negative result. However, the literature confirms that the reliability of positive screening results is limited, particularly for microdeletions. Reliability of positive screening results in these studies was best for Down syndrome, with a positive predictive value of about 90%, meaning that one in 10 positive results are not confirmed as Down syndrome. However, reliability of positive screening results was far lower for microdeletions, with the positive predictive value ranging from about 2% to 30%, depending on the condition. For example, Di George syndrome, which is caused by a microdeletion on chromosome 22, showed a positive predictive value of about 30%. This means that, out of 10 patients receiving a positive result for Di George syndrome on a screening test, it is not confirmed in 7 of those patients when diagnostic testing is performed with CVS or amniocentesis.
The FDA is informing the public of the risks related to the use of genetic prenatal screening and the potential harm if NIPS test results are not used and interpreted appropriately.
The FDA encourages test developers to provide accurate, clear, and complete information about the performance of their tests, how they should be used, and what the results may or may not mean. The FDA also encourages test developers to work with the FDA toward authorization, clearance, or approval of their tests.
The FDA will continue to closely monitor safety issues around the use of NIPS tests and is committed to protecting public health. The FDA will keep the public informed if significant new information becomes available.
Reporting Problems with Your Device
If you think you had a problem with a non-invasive prenatal screening (NIPS) test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.
Colorectal cancer is the third-most-common cancer in both men and women in the United States and is the second-most-common cause of death from cancer, behind only lung cancer. Because most cases of colon cancer take years to develop, we have an opportunity with regular screenings to not only catch cancer at an early, curable stage, but with colonoscopy, we can also remove the precancerous polyps and prevent cancer from developing.
As we commemorate Colorectal Cancer Awareness Month, I want to make sure everyone is aware of the latest guidelines on colorectal cancer screening. In 2021, the U.S. Preventive Services Task Force updated its recommendations on colon cancer screening to offer screening at age 45 for all average-risk adults. Part of the rationale to lower the age for screening is that despite improvements in the overall trends of colon cancer cases and deaths over the past few decades, we have seen as much as a 15% increase in the number of colorectal cancer cases in adults ages 40 to 49.
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While we say that the best screening option is whatever test has the highest likelihood of a patient completing it, there are two major testing approaches most often used in the U.S. that are supported by the highest-quality evidence: colonoscopy and stool-based testing.
The benefit of a colonoscopy is that it is both diagnostic and therapeutic. This means that whatever we find during the screening, such as precancerous polyps, we remove at the time of screening.
Stool-based testing strategies, such as an annual fecal immunochemical test (FIT) or a multitarget stool DNA test every three years, are also highly effective strategies. However, stool-based testing is considered a two-step strategy, because any positive test still requires a colonoscopy for follow up to remove any polyps. Less commonly used screening tests include flexible sigmoidoscopy, CT colonography or colon video capsule. These tests do not have as much evidence supporting their use and should be reserved for patients unable or unwilling to undergo colonoscopy or annual FIT testing.
When deciding which screening approach to use, patients should also consider their overall risk for colon cancer. Stool-based testing should only be used by “average-risk” patients, so anyone at higher risk for colon cancer based on a personal history of colon polyps, a family history of colon cancer or an underlying medical condition such as inflammatory bowel disease should not use a stool-based screening option and should instead undergo a colonoscopy. Depending on a patient’s risk factor, the age at which to start screening could be younger than 45, and this decision is best made with the input of a primary care physician or a gastroenterologist.
How UVa Cancer Center can help
The UVa Cancer Center — one of just 52 National Cancer Institute-designated comprehensive cancer centers in the U.S. and the only one in Virginia — offers exceptional screening and care for colorectal cancer. UVa provides the full range of colorectal cancer screening options for patients, including high-screening colonoscopy to patients, as well as diagnostic colonoscopy for patients with a positive stool test. Our gastroenterologists perform high-quality colonoscopy and offer advanced endoscopic options for patients with complicated adenomas.
For patients who need surgical care for colorectal cancer, U.S. News & World Report rates colon cancer surgery at UVa as “high performing” – the best possible rating. To learn more about colorectal cancer screening and treatment options at UVa, visit uvahealth.com/services/colon-health.
Dr. Esteban Figueroa is a gastroenterologist at UVa Health.
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Genetic testing scams are rapidly becoming one of the top major fraud schemes across the country.
Medicare beneficiaries are being targeted by unscrupulous telemarketers, door-to-door salesmen, and seemingly helpful people manning the booth at a local health fair who claim that Medicare will pay for it and the test will be free. Don’t fall for it and certainly don’t hand over your Medicare card or agree to pay if the test is not prescribed by your doctor. Remember, if it sounds too good to be true, it probably is.
EXAMPLES OF GENETIC TESTING FRAUD
•A company or individual offers you “free” or “at no cost to you” testing without a treating physician’s order. The company then bills Medicare (usually thousands of dollars) for a broad range of genetic tests that you did not request or possibly even receive.
•A company or individual uses “telemedicine” to offer testing to you over the phone and arranges for an unrelated physician or “teledoc” to order the test.
•A company or individual sends you a kit for genetic testing and asks that you return the test with your Medicare number.
•A company or individual tries to bill Medicare for pharmacogenomic tests (to determine how you metabolize drugs) that are neither covered by Medicare or apply to you.
Here are just a few questions to ask when encountering potential genetic testing scams along with answers that provide information and guidance about how to handle each situation.
Q. Did the person/provider offer you a genetic test to screen for cancer or another condition?
A. Decline the offer. With so much interest in genetic tests as early warning systems for cancer, it makes sense that beneficiaries and others would wonder if Medicare covers genetic testing as a screening and prevention benefit. The answer, with one exception, is no. Although Medicare covers many genetic tests for diagnostic use, it only covers one genetic test to screen for cancer.
Since October 2014, Medicare Part B has paid for the Cologuard test, manufactured by Exact Sciences Corp of Madison, Wisconsin, to screen specifically for colorectal cancer. Scammers often refer to these tests as hereditary cancer screenings, DNA screenings, cancer screenings, genetic testing, pharmacological testing, Alzheimer’s screenings, dementia screenings, heart disease screenings, gene mutation screenings, genetic marker screenings, etc. Regardless of what the person calls it remember Medicare does not cover genetic tests to screen for cancer — except for one colorectal cancer DNA screening test from “Cologuard.”
Q. Did the person/provider say that Medicare covers genetic tests at no cost to you?
A. The tests are usually described as being available and useful for a wide range of people regardless of their health condition. Scammers will try to tell you that a person’s insurance will cover the tests for “free.” They make this claim because Medicare pays for diagnostic lab tests according to a fee schedule, with no deductible or coinsurance costs for patients, but only when medically necessary. The tests are only medically necessary with a treating physician’s order. If Medicare denies the tests, you could be charged the entire amount, which could easily run $9,000 to $11,000.
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Q. Did the person/provider say that Medicare covers this as a preventative test?
A. As mentioned earlier, Medicare does not cover genetic tests to screen for cancer as a preventative benefit, with only one exception for a colorectal cancer DNA screening test.
Q. Did the person/provider tell you what they are doing the genetic test for or which cancers they are testing for?
A. Medicare does not cover genetic tests for beneficiaries who do not have any symptoms or diagnoses of cancer. Medicare rules specifically state the following:n “Tests for screening purposes that are performed in the absence of signs, symptoms, complaints, or personal history of disease or injury are not covered as explicitly authorized by statute.”
Q. Did the person/provider tell you who would be following up with you regarding the results? Did the provider read your results and, if needed, use them to set up a treatment plan?
A. Lab tests like this must be ordered by a treating physician. Medicare rules state:
“All diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests must be ordered by the physician who is treating the beneficiary, that is, the physician who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary’s specific medical problem. Tests not ordered by the physician who is treating the beneficiary are not reasonable and necessary.”
Q. Did the person/provider use scare tactics such as “your prescriptions could kill you” or “to prevent cancer,” claiming cancer and using the wrong prescription as the biggest killers of seniors?
A. If you have concerns about how your body is metabolizing your prescriptions or if you are at risk for cancer, you should talk with your health care provider, who should be aware of the prescriptions that you are on and your family’s medical history.
Your Pennsylvania Senior Medicare Patrol (SMP) is ready to provide you with the information you need to PROTECT yourself from Medicare fraud, errors, and abuse; DETECT potential fraud, errors, and abuse; and REPORT your concerns. SMPs and their trained volunteers help educate and empower Medicare beneficiaries in the fight against health care fraud. Your SMP can help you with your questions, concerns, or complaints about potential fraud and abuse issues. To receive local services in Pennsylvania visit or call (800) 356-3606.
(Joel Mekler is a certified senior adviser. Send him your Medicare questions at [email protected].)
What is genetic testing? It refers to medical testing to identify changes within chromosomes, genes or proteins encoded by these genes. The purpose is to confirm or exclude a genetic disorder, or to quantify the risk that an individual carries, will pass on, or will develop such a disorder.
Genetic testing within pregnancy is usually carried out on a routine basis to exclude a few conditions such as cystic fibrosis, Fragile X syndrome, sickle cell disease, Tay-Sachs disease and spinal muscular atrophy. Expanded genetic carrier modules are now becoming available that can detect >400 new diseases.
The indications for genetic counseling in pregnancy may include:
Family history of genetic disease or chromosomal anomaly; abnormal development; birth defect;
Abnormalities during newborn screening, or any developmental problem at birth or during childhood, for the children of any family member
Prior history of preterm birth, two or more miscarriages, stillbirth, or sudden infant death syndrome (SIDS), or child with any congenital anomaly or genetic disease
History of infertility
Abnormal images on the multiple marker screen or ultrasound scanning in early pregnancy
Mothers will be 35 years or older at the time of delivery
Exposure to agents that may affect the genes, such as medications or environmental toxins
Consanguinity of the parents
Certain ethnic backgrounds associated with specific genetic defects
The presence of any of these indications should lead to counseling on the genetic risk, based on which a decision to carry out genetic testing is made to identify the presence of such conditions.
Stages of genetic testing
Preimplantation genetic diagnosis (PGD)
PGD comprises the testing of cells from a very early embryo, obtained through in vitro fertilization (IVF), grown to the stage of uterine implantation in an external medium. These cells are subjected to genetic testing, following which the embryo is discarded or implanted.
This refers to the performance of genetic tests on a fetus when there is a risk of having a baby with genetically determined mental retardation or physical deterioration. It is extremely controversial because the only option to deal with the identified genetic issues in the offspring is by aborting the pregnancy.
In the case of some anomalies such as Down syndrome, the fetus is aborted on the basis of a feared mental deficit, which is not always the case. Also vexed is the right to abort a fetus simply because the sex is wrong.
This consists of measuring certain hormones (alpha-fetoprotein, human chorionic gonadotropin (hCG), unconjugated estriol, and inhibin) in the mother’s blood – the triple or quad screen, alias the multiple marker screen, alias the AFP plus) – coupled with an ultrasound scan to evaluate the thickness of the skin on the back of the baby’s neck – the nuchal translucency test. Increased fluid accumulation or a cystic appearance could signal trisomy 21, or congenital heart disease. It will pick up >90% of Down syndrome cases, and other chromosomal anomalies.
Cell-free DNA (cfDNA) screening or non-invasive prenatal testing (NIPT) targets the minute amounts of fetal DNA fragments circulating in the maternal blood, to identify patients at high risk for such abnormalities, assuming that the maternal and fetal genomes will be identical. This allows more sensitive detection of most of the trisomies commonly encountered and a lower false-positive rate.
This refers to procedures like amniocentesis and CVS, where a needle is used to draw out amniotic fluid or small amounts of placental tissue, respectively, under ultrasound guidance, for genetic testing. Percutaneous Umbilical Blood Sampling (PUBS, Cordocentesis, Fetal Blood Sampling) is another method used at 20 weeks of pregnancy or later, for special indications only.
Sometimes, the counseling helps parents understand their chances of transmitting an abnormal gene to the baby.
If the gene is one of a pair of which both are required for normal function, both parents must have and pass on a defective copy if the baby is to get the disease. If only one parent has one defective copy, he or she may pass it on to some of the babies, but has no symptoms. Such an individual is a carrier, and the baby also becomes a carrier.
If two carriers have a baby, in 25% of cases the offspring will receive one copy of the defective gene from each parent, and will develop the disease. This is a high risk for disease.
Some examples are sickle cell disease in several Black communities and many tribal communities in India, and the Tay-Sachs disease in Ashkenazi Jews. Carrier screening is suggested to check for the presence of such a gene in potential parents if they so desire.
At present, universal genetic testing is recommended to rule out cystic fibrosis and spinal muscular atrophy, while all women should be checked for the presence of hemoglobinopathies.
Genetic testing is controversial among many mothers to be, who do not wish to reject their babies on any pretext.
Secondly, screening tests based on blood markers are not 100% perfect, and the resulting risk is a potent source of stress on the parents. Even if the baby does inherit defective genes, it does not follow that symptoms will arise or that the child will develop severe disease, the results do not convey the risk of progressive disease.
Thirdly, genetic tests may bring to light existing or potential conditions that were previously unknown, uncovering unwelcome knowledge about the potential for each parent and their families to develop certain conditions, but without the possibility of avoiding or averting them. This is surely a source of great stress.
There is a further issue in that the family history revealed by these tests would typically be confidential, but is unselectively shared by the individual being tested, leading to a breach of medical confidentiality and personal privacy.
Conversely, if genes that could affect other family members directly or indirectly are discovered, would it not be the right of the physician or test recipient to inform those at risk? These are perplexing questions without clear answers.
There is also a high possibility that a genetic test showing a problem with the fetus may be used to discriminate against the parents or the fetus, or both.
The question of health equity in genetic testing also arises. Since it will be mostly the rich who have access to genetic testing, the percentage of babies with genetic anomalies may become skewed towards lower socioeconomic backgrounds. This is already the case, according to some experts.
Each test also has its risks, such as amniocentesis and chorionic villous sampling, that can cause pregnancy loss in a small but significant number of cases.
Cost-effectiveness may also be in question, as, according to one study, the costs of universal screening for cystic fibrosis in order to avoid the birth of one affected baby are many times higher than the costs of managing that one individual medically over a lifetime.
And finally, eugenics and social engineering risks may eventually win the day. Eugenics refers to “the practice of manipulating the genes of offspring through either breeding or genetic alteration.”
According to Leon Kass, “To be sure, my genetic vices are, as far as I know them, rather modest, taken individually -myopia, asthma and other allergies, bilateral forefoot adduction, bowleggedness and pessimism, plus some four to eight as yet undiagnosed recessive lethal genes in the heterozygous condition-but taken together, if diagnosable prenatally, I might never have made it.”
Most deaths today are still not due to genetic factors, but rather occur in so-called normal healthy people. By pursuing genetic testing in pregnancy, will we head towards a society of ‘perfect’ offspring, and conversely, one which has zero tolerance for those not ‘perfect’? Is this even achievable, and if so, desirable? It would probably be best to conclude that while technology advances, intensive efforts must be taken to avoid the unfair and discriminatory use of such technology.