FDA approves first ever diagnostic test for Mycoplasma genitalium

The US Food and Drug Administration (FDA) approved the first-ever diagnostic test to aid in the diagnosis of sexually transmitted Mycoplasma genitalium infection. The Aptima Assay from Hologic Inc, is the only FDA-approved test to detect this under-recognized but increasingly common sexually transmitted infection (STI).

First discovered in the early 1980s, M. genitalium was listed as an emerging public health threat by the U.S. Centers for Disease Control and Prevention (CDC) in 2015. Currently, it is responsible for causing approximately 15 to 30 percent of persistent or recurrent urethritis cases in men in the United States and 10 to 30 percent of cervicitis cases in women.

This slow-growing pathogen is difficult to detect by traditional laboratory testing methods. In the absence of FDA approved diagnostic test, the STI is often misdiagnosed and treated with wrong antibiotics resulting in persisting infection and widespread transmission.

“Although Mycoplasma genitalium is typically more common than gonorrhea, there is very little public awareness of this rising sexually transmitted infection, which can cause serious and potentially devastating health problems,” said Damon Getman, Ph.D., senior principal research scientist and director of research at Hologic in a press release.

The Aptima Assay is a nucleic acid amplification test, which detects M. genitalium in urine samples and urethral, penile meatal, endocervical or vaginal swab collected in a clinical setting, such as a doctor’s office or clinic.

In the clinical study involving 11,774 samples, the Aptima test correctly identified M. gen. in approximately 90 percent of vaginal, male urethral, male urine and penile samples. It also correctly identified the presence of the pathogen in female urine and endocervical samples 77.8 percent and 81.5 percent of the time.

The test also has a high negative predictive value and correctly identified the negative samples 97.8 to 99.6 percent of the time. Vaginal swabs are the preferred samples to perform the test, but urine samples can be used as alternative sample types.

The assay is immediately available at clinical laboratories, physicians and healthcare providers can immediately order the tests by reaching out to the labs. Hologic further anticipates that most insurance plans will cover the testing for M. genitalium.

The Aptima Mycoplasma genitalium Assay was reviewed through the de novo premarket pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.  The FDA exercises special controls over the individual tests approved by the de novo premarket route to ensure the safety and effectiveness of the tests.

The newest M. genitalium assay joins the comprehensive list of men and women’s health assays by Hologic that include sexual and cervical health, and virology testing.

FDA press release

Hologic press release

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FDA clears first ever test to analyze the nutrients in Human Breast Milk

The U.S. Food and Drug Administration recently permitted marketing of a diagnostic test that analyzes nutrients in breast milk. The test will help healthcare providers in managing the specific nutritional needs of newborns and young infants at risk for growth failure due to prematurity or other medical conditions.

Developed and marketed by a Swedish company Miris, the Miris HMA - Human Milk Analyzer reports the fats, carbohydrates, proteins, and energy content of the milk within 60 seconds using 1-3 cc of the milk. 

“For the first time, doctors have access to a test to help analyze the nutrients in breast milk. While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected,” said Courtney Lias, Ph.D. director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health in a press release.

“Breast milk provides many health benefits to infants, and for many babies, it can meet their early nutritional needs. But some infants — including those who may be born preterm or have certain health conditions — may need additional nutrients in order to support their optimal growth,” she further added.

“Knowing the macronutrient content of the breast milk may help the health care team and parents make informed decisions on how to fortify the breast milk based on the individual needs of the infant,” explains FDA in the recent press release.

The Miris Human Milk Analyzer can be purchased only through prescription and is for use by trained personnel at clinical laboratories. The device uses approved Infrared transmission spectroscopy to analyze accurately the total solids and energy content contained in the milk along with quantitative measurement of fat, protein and total carbohydrate in a single run.

The device does not use any chemicals and is small, portable and easy to use. The results can be easily transferred to a computer.

The FDA reviewed the Miris Human Milk Analyzer test through the De Novo premarket review pathway and clearance was based on comparable results obtained by analysis of 112 samples of human milk tested by the Miris analyzer and by independent methods. Both methods were equally effective at determining levels of protein, fat, and carbohydrates in the milk.

Certain conditions may limit the ability of the test to accurately determine the milk content like some medications taken by a nursing mother. FDA advises the healthcare provider to use the test results of Miris Human Milk Analyzer along with clinical parameters of the baby in formulating the nutritional plan for the infant and in informed decision making.

FDA has also put in place specific criteria called “special controls” to ensure the accuracy and reliability of the test results and to aid in the nutritional management of certain infants. These “special controls” along with general control helps maintain the specificity and accuracy of this type of tests.

Here is a short overview of how the Miris HMA - Human Milk Analyzer works.

Product page

FDA press release

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FDA approves sarecycline for the treatment of moderate to severe acne

The US Food and Drug Administration (FDA) today approved sarecycline (Seysara, Almirall) for treating the inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

Seysara™ is specifically designed antibiotic for dermatologic use in four decades. The drug has narrow -spectrum of activity explicitly targeting acne and rosacea specific pathogens (P. acnes, Staphylococcus aureus) and has limited activity against aerobic gram-negative gastrointestinal organisms compared to minocycline and doxycycline.

Its anti-inflammatory property is a plus to treat the inflammation associated with skin lesions of acne, and long half-life enables convenient once a day dosing.

The approval follows the encouraging results of two replicative, Phase III, randomized, multicenter, double-blind, placebo-controlled studies that compared sarecycline to placebo. Sarecycline was administered in the dose of 1.5 mg/kg/day for 12 weeks. The studies looked at nearly 2000 patients aged 9 years and above and found the drug to be significantly effective in bringing down the inflammation as early as 3 weeks of starting treatment.

"As dermatologists, we are always seeking ways to improve the management of our patients' disease. The results of the studies are encouraging, with statistically significant efficacy vs. placebo as early as 3 weeks. I am looking forward to having this as an option for my patients when it becomes available in 2019," Leon Kircik, MD, who participated in clinical trials for Seysara.

Allergan has U.S. rights to the development and commercialization of Seysara and has assigned such rights to Almirall SA, while Paratek retains all ex-U.S. rights.

Common side effects noted were nausea, headache, and nasopharyngitis, but the discontinuation rates because of side effects were as low as 1.4%.

The drug is contraindicated in patients with hypersensitivity to any of the tetracyclines and may cause permanent tooth discoloration if used during the tooth development phase. It should only be used when indicated to avoid development of antimicrobial resistance and should be discontinued in the event of  Clostridium difficile-associated diarrhea (antibiotic-associated colitis), or intracranial hypertension occur.

According to GlobalData analysis acne vulgaris (acne) is one of the most common dermatological conditions, affecting around 90% of the world’s population at some point in their lifetime. Other major classes of drugs used for the treatment of acne are retinoids, anti-androgens, antibiotics, and benzoyl peroxide.

Sarecycline will face competitions from two late-stage pipeline drugs with antibiotic properties: Foamix Pharmaceuticals’ FMX-101 and Dermira’s olumacostat glasaretil. Along with these drugs, Sarecycline will provide newer treatment options for patients with acne vulgaris.

New Release 

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FDA approves elagolix (Orilissa), the first and only oral treatment for endometriosis pain

The U.S. Food and Drug Administration (FDA) today approved ORILISSA™ (elagolix), the first and only oral gonadotropin-releasing hormone (GnRH) antagonist especially useful in the management of women with moderate to severe endometriosis pain— announced AbbVie and Neurocrine Biosciences.

Orilissa represents the first FDA approved oral treatment for endometriosis in over a decade and is expected to be available in U.S. retail pharmacies in early August 2018.

The drug is available in two oral dosages-150 mg once daily and 200 mg twice daily, taken with or without food roughly at the same time every day.

The FDA approval is supported by the results of 2 of the largest, randomized, double-blind, placebo-controlled phase 3 trials conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. Women either received 150 mg, 200 mg (952 women) or a placebo (734 women) and were evaluated at the end of 3 months.

Of the women in the treatment arm, 475 received a 150-mg daily dose, while and 477 received a 200-mg twice-daily dose.

Clinical trial results demonstrate that Orilissa significantly reduced all the 3 types of pain commonly associated with endometriosis— daily menstrual pelvic pain, non-menstrual pelvic pain, and pain with sex (p <0.001). Furthermore, women on 200 mg dose showed a significant reduction in dyspareunia as compared to placebo.

The most significant side effect observed with elagolix is dose-dependent decreases in bone mineral density; limiting the treatment to either 150 mg daily for up to 24 months or 200 mg twice daily for up to 6 months.

Bone mineral density loss is not entirely reversible on stopping the treatment. Other adverse effects are reported in 5% of patients and include hot flashes/night sweats, headache, and nausea, difficulty sleeping, an absence of periods, anxiety, joint pain, depression and mood changes.

"ORILISSA represents a significant advancement for women with endometriosis and physicians who need more options for the medical management of this disease," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. "The approval of ORILISSA demonstrates AbbVie's continued commitment to address serious diseases and unmet needs."

"Endometriosis is often characterized by chronic pelvic pain that can impact women's daily activities," Hugh Taylor, MD, study investigator from Yale University School of Medicine in New Haven, Connecticut, said in the release. "Women with endometriosis may undergo multiple medical treatments and surgical procedures seeking pain relief, and this approval gives physicians another option for treatment based on a woman's specific type and severity of endometriosis pain."

AbbVie is going to role in an application for the approval of elagolix in Uterine Fibroids too; the drug has already shown promising results in initial trials conducted by the drug manufacturer.

AbbVie press release

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FDA approves Senhance Surgical Robotic System to facilitate minimally invasive surgery

FDA today approved Senhance Systems, by TransEnterix, Inc., a medical device company that is pioneering the use of robotics to improve minimally invasive surgery.

Robotically-assisted surgical device (RASD) is a type of computer assisted surgical system, which helps surgeon to control, view and move the surgical devices through small ports of minimal invasive surgery in a variety of surgical procedures. It specifically has gynecological and colorectal applications.

The system enables the surgeon to sit in a console or a cockpit of some sort, which provides him or her with a 3D, high-definition view of the surgical field and allows for the control of the system’s 3 robotic arms. At the end of each of the 3 arms are mounted surgical instruments that are based on traditional laparoscopic instrument designs. This increases the surgeon’s comfort and reduces strain.

The system allows the surgeon to “feel” the stiffness of tissue during operation with its force feedback technology. It also features eye-tracking to allow for comparative movement of instruments to standard operations. It facilitates highly efficient operations with minimal additional docking time or change to technique.

 It allows for the visualization and endoscopic manipulation of human tissue, such as grasping, cutting, blunt and sharp dissections, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery," according to the FDA. 

“Minimally invasive surgery helps reduce pain, scarring and recovery time after surgery,” said Binita Ashar, M.D., director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health. “RASD technology is a specialized innovation in minimally invasive surgery designed to enhance the surgeon’s access and visualization within confined operative sites.” 

The clearance was based on results of a pilot study in which 150 patients underwent various gynecological operations with the Senhance System. The clinical outcomes were compared with outcomes of nearly 8000 surgeries in real world settings using another RASD.

In addition to gynecological surgeries, 45 colorectal sureries were also performed by Senhance system and compared to outcomes of other real-world surgeries.

Based on the study results, real world evidence and simulations, the FDA concluded that the  Senhance System is substantially equivalent to the da Vinci Si IS3000 device for gynecological and colorectal procedures.

Here is a  video of Senhance Surgical Systems. 


Senhance Surgical Robotic System - Functional Overview from TransEnterix, Inc on Vimeo.

CompuFlo precise computer-controlled Epidural anesthesia system won clearance from the FDA.

Milestone Scientific, Inc., a company based at Livingston, New Jersey, has designed CompuFlo® Epidural instrument that uses dynamic pressure sensing (DPS) to help anesthesiologists to quantitatively determine and document the pressure at the needle tip in real-time.

The computerized system provides visual and audible feedback of the pressure which enables the anesthetist to correctly identify the epidural space and significantly reduce complications in real-time, according to Milestone.

Leonard Osser, Chief Executive Officer of Milestone Scientific commented, "We are delighted to receive marketing clearance from the FDA, which is considered globally to be the regulatory gold standard in premarket review."

The clearance was based on results of the COMPASS Study (CompuFlo Assessment Study), which was a prospective, randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of epidural space verification with the CompuFlo Epidural Instrument.

The study enrolled 400 patients, of whom 240 required epidurals as a relief from chronic pain and 160 patients were women, requiring epidural for pain management in labor and delivery.

The technique also showed the same efficacy in 21 obese patients with BMI > 31.

The application benefits of Milestone's CompuFlo-based Epidural Injection System are numerous and well defined, and include:

• materially reducing, and possibly eliminating, existing medical risks and complications associated with administering epidurals
• improving patient safety and comfort
• reducing liability to medical care providers/institutions
• reducing malpractice clams and related insurance premiums for anesthesiologist

The CompuFlo Epidural with Dynamic Pressure Sensing Technology is contraindicated in patients with prior back surgery in lumbar area, skin condition in their lumbar region greater than 4 sq cm and to infuse medication.

Media Courtesy: Milestone Scientific, Inc.