NEWBORN ECG SCREENING DEVICE

CARDIOVASCULAR

CLASS II

ECG screening tests on newborns are plagued by artifacts caused by incorrect positioning of adult size chest leads on a small torso, accidental limb lead reversal, and movement of the patient. QT Medical has developed a miniature newborn 12-lead ECG screening device, including a compact ECG recorder and a uniquely-shaped electrode strip created specifically for newborns. The system is initially targeting the screening of newborns for long QT syndrome at 2-4 weeks of life, but can replace standard ECG devices for any 12-lead ECG in newborns and infants.

EPIPACE, AN EPICARDIAL MICRO-PACEMAKER

CARDIOVASCULAR

CLASS III PRECLINICAL

Conventional cardiac pacemakers employ electrodes routed through the large veins and attached to the endocardial surfaces of the right heart. This approach is unsuitable for very small children and for adults with contra-indications to intravascular devices such as bacterial endocarditis and clotting disorders. This novel micropacer can be affixed to the epicardial surface in minimally invasive procedures via a catheter or cannula. The first such device was designed for percutaneous implantation into a fetus in utero to deal with rare but life-threatening bradycardia and hydrops. Subsequent designs allow implantation via pericardial catheter in both children and adults. While minimally invasive transvenous systems are currently under development by major medical device manufacturers, a minimally invasive epicardial system would greatly benefit the population of children and adults who currently require extensive surgery for epicardial pacemaker placement (due to inability to undergo transvenous pacemaker implantation). In addition, such a minimally invasive system can ultimately replace nearly all single-chamber pacemaker implantations due to the less invasive approach while at the same time offering more physiologic pacing (by pacing the left ventricle directly).

POLYVASCULAR, A STENT MOUNTED HEART VALVE

CARDIOLOGY

CLASS III PROTOTYPE

Congenital heart defects are the most common of all birth defects and remain amongst the leading causes of infant mortality in the developed world. Multiple types of congenital heart defects require valve replacement surgery. Pulmonary valves are usually replaced using cadaveric homograft valves, since mechanical valves have increased risk of thrombosis in the pulmonary position. Homograft pulmonary valves are not commonly available, particularly in sizes suitable for use in children. Moreover, these valves do not grow with the patient, becoming too small as the child grows. All these factors result in the need for repeated valve replacement surgeries. Therefore, there is an urgent need of solutions to limit the frequency of repeated valve replacement surgeries for these children. Polyvascular is developing an innovative stent mounted heart valve that does not contain any biologic tissue, limiting any immune sensitization and that can be delivered via cardiac catheterization, eliminating the need for open heart surgery. This heart valve is also expandable over time and will follow the child's growth, eliminating the need for multiple surgeries.

ARTERYS, A 4D BLOOD FLOW MRI IMAGING SYSTEM

CARDIOLOGY

CLASS II MARKETING

Structural and congenital heart diseases are typically diagnosed using lengthy procedures that are highly subjective. As a result, patients are often misdiagnosed, multiple diagnostic tests are performed, or patients get the incorrect treatment. Regular cardiac MRI can obtain a few blood flow measurements but it is typically not used because it is far too cumbersome and time consuming. There is a need for a non-invasive, fast and accurate method to diagnose those structural heart diseases. Arterys' solution is a simple single-click operation generating data in under 8 minutes. It combines MRI imaging data with a cloud based computation system that generates an accurate and comprehensive map of the heart. The cloud-based computational system minimizes upfront costs and hardware purchases.

PROTOTYPE

MIC, A DETERIORATION MONITOR FOR HLHS PATIENTS

CARDIOLOGY

CLASS II PROTOTYPE

Hypoplastic left heart syndrome (HLHS) is a birth defect that affects normal blood flow through the heart. As the baby develops during pregnancy, the left side of the heart does not form correctly. Hypoplastic left heart syndrome is one type of congenital heart defect. HLHS patients require three stages of palliative surgery to survive. There is high risk of mortality of around 13-15% between stage 1 and stage 2 palliative surgeries for patients with HLHS. There is currently no calibrated measure of risk to detect early deterioration of individual patients in real-time that could alert care teams and allow them to intervene before the situation becomes life threatening. This unique monitor, developed by Medical Informatics, provides a relative risk index algorithm for measuring the relative risk of deterioration 1 to 2 hours in advance of a deterioration event (such as a cardiac or respiratory arrest requiring CPR and/or intubation) in HLHS patients that have undergone the Norwood procedure (stage 1).

RESPIVICE, A PERSONALIZED VENTILATION MANAGEMENT SYSTEM

EAR, NOSE, AND THROAT

CLASS II CLINICAL

Endotracheal intubation is the most common supportive therapy applied in both adult and pediatric intensive care units. Performing endotracheal intubations particularly in children is complex leading to complications during placement, extubation and weaning such that clinicians could benefit a great deal from additional diagnostic tools to monitor respiratory performance data. The Respivice system will (1) optimize ventilator support during the acute phase of illness (2) improve efficiency of weaning the mechanical ventilator (3) prevent re-intubation related to UAO and (4) optimize the efficiency of non-invasive ventilation management. Hospitals are being paid a flat reimbursement rate based on diagnosis and level of complexity. Hence, longer lengths of time on the ventilator and potentially preventable complications such as upper airway obstruction will lead to longer hospital lengths of stay, and loss of revenue for the hospital. Respivice can improve the quality and efficiency of care thereby substantially reducing hospital length of stay and length of mechanical ventilation.

DETON, A RESPIRATORY INFECTION DIAGNOSTIC SAMPLE COLLECTION DEVICE

EAR, NOSE, AND THROAT

CLASS II CLINICAL

Tuberculosis (TB) is a major threat to global public health with 9M new actives cases per year. Despite the availability of a cure, 1.5M TB patients die every year because they are not diagnosed. Diagnosis of active TB infection requires sputum sample collection and over 3 million TB patients cannot produce a sample, of which many children. Children therefore require special care such as sputum induction and gastric aspiration. When the induction is not successful, a more expensive technique is performed, a bronchoalveolar lavage (BAL), using fiberoptic bronchoscopy. Those techniques are invasive, very unpleasant and a potential cause of infections. In developing countries, induction and BAL are not readily available and a significant number of patients unable to produce sputum remain undiagnosed. This new closed-system collection device provides a non‐invasive, simple and cost-effective alternative when sputum cannot be obtained. A palm-sized disposable device captures airborne bacteria directly from a cough which collects on a tablet surface, transferred into a buffer and analyzed via standard of care.

E-VENTILATOR, A DIGITAL VENTILATOR MANAGEMENT PROTOCOL

EAR, NOSE, AND THROAT

CLASS II CLINICAL

Ventilation management is the accumulation of multiple decisions. This type of iterative decision making is amenable to guidance using a medical treatment protocol. Medical treatment protocols facilitate consistent, evidence-based decisions for equivalent patient states and digital protocols improve adherence over paper protocols. E-Vent is an electronic decision support tool translated from an adult ventilator protocol that improves management of pediatric and adult patients with acute hypoxemic respiratory failure.

NEXT GENERATION CYSTIC FIBROSIS DIAGNOSTIC TEST

GENERAL HOSPITAL

CLASS II CLINICAL

Cystic fibrosis (CF) is a life-threatening genetic disease that primarily affects the lungs and digestive system. An estimated 30,000 children and adults in the United States (70,000 worldwide) have CF. CF is caused by mutations in a gene that produces a protein, called CFTR. The CFTR protein controls the flow of salt and water in and out of the cells of organs like the lungs and pancreas. CF is usually diagnosed by conducting a QPIT sweat test, which measures the amount of chloride in a person’s sweat. However, this test is only valid for patient with severe disease and does not take into account the spectrum of pathologies associated with variable degrees of CFTR dysfunction. This is particularly the case with adolescents, adults, and asymptomatic infants identified as being at risk for CF and presenting with milder symptoms of the disease. This new method is based on beta adrenergically induced sweat secretion. The rate of b-adrenergically stimulated sweating is used of diagnose CF disease and reflect the probability of underlying genotypes. B-adrenergic sweat secretion rates are assessed with an evaporimeter to provide an accurate, reliable and practical real-time assay over a range of CFTR functional activity in vivo. This new test will be a very valuable asset to diagnose CF disease and a possible biomarker for CF drug efficacy testing.

HYPOTHERMIA DEVICE

GENERAL HOSPITAL

CLASS II A PROTOTYPE

Hypothermia has traditionally been one of the most common treatments for tissue injury. As established by eleven controlled randomized trials, however, one of the most significant uses of hypothermia is for treating neonatal Hypoxic ischemic encephalopathy (HIE). When used to treat HIE, hypothermia can prevent one death or disability for every six treated newborns. This makes hypothermia treatment for HIE one of the most successful interventions in all of medicine. Despite these encouraging facts, 40-50% of babies with HIE die. Part of the problem is that systemic hypothermia is hard to implement in newborns since their immature thermo-regulation mechanisms, mostly depending on brown fat stores and non-shivering thermogenesis, make it difficult to maintain their temperature. Existing cooling devices are not designed to address the requirements of stability, transportability and efficiency required for the treatment of these delicate patients. Hypothermia Device is an intelligent brain and neck cooling device that has a state of the art temperature regulating element with a small footprint. The cooling devices are electronically controlled in order to produce rapid and efficient temperature transitions constrained by direct reading of temperatures at the skin (or scalp) to keep them within ranges that are safe to the patient. The Hypothermia Device has developed flexible and ergonomic cooling/heating pads to be placed in contact with the skin for a wide variety of applications for various human tissues (i.e. brain, neck, leg muscles, arm muscles, back muscles, joints, etc.).

AGC, AN INTELLIGENT SOFTWARE SOLUTION FOR INSULIN-PUMP

GENERAL HOSPITAL

CLASS II CLINICAL

Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow glucose to enter cells to produce energy. Despite active research, type 1 diabetes has no cure but it can be managed. Careful management of type 1 diabetes can reduce the risks of serious, even life-threatening complications. Currently, managing diabetes is relentless. Patients need to constantly measure their glucose level and take insulin accordingly. They are two technologies available on the market, the insulin pump and the continuous glucose monitor (CGM) sensor. Unfortunately there is no connection between those two technologies to create a virtual “artificial pancreas”, that would allow an automated glucose control for the patient. AGC (Automated Glucose Control) is a sophisticated computer program that can be used with current insulin pump systems pumps/CGM to provide automated, intelligent, personalized insulin therapy. Such a “closed-loop system” requires little, or possibly no, input from the user and provides real-time information discretely to the user’s smartphone application. Clinical studies have shown a 5-fold reduction in A1c using the AGC software.

SINGLESTICK, A VASCULAR ACCESS DEVICE

GENERAL HOSPITAL

CLASS II PROTOTYPE

Obtaining pediatric vascular access (peripheral IVs, central venous catheters, arterial lines, etc.) is difficult due to the children’s smaller vascular anatomy and pediatric CVC’s procedures are associated with a high complication rate of 23%. It is well known that delaying vascular access can lead to serious medical complications, especially during surgery and when medical resuscitation is necessary. These complications can be very dangerous and costly to the hospital. SingleStick, allows for real-time integrated imaging of the needle’s trajectory. The procedure to place a line remains the same but with the added benefit of imaging. This means that the practitioners will be able to see the vein they are trying to enter, as well as, avoid other anatomy they do not want to hit (i.e. arteries and lungs).

BEST DOSE, A DECISION SUPPORT SYSTEM FOR PERSONALIZED MEDICINE

GENERAL HOSPITAL

CLASS II CLINICAL

There are 1.5M preventable adverse drug events in the US that cost the healthcare system $4B annually. Best Dose is a decision support system for personalized medicine. It uses proprietary algorithms to control drug variability and individualized dosing. The software is operated by the clinician who is able to set clinical targets for an individual patient, including blood concentration of a drug that has been shown to be safe and effective. The program then combines the patient's personal medical information with a drug model to generate an optimal dose recommendation. The software will be integrated with hospital electronic medical records systems, allowing ease of use in the clinical environment.

NONINVASIX, A NEONATAL CEREBRAL CIRCULATION MONITOR

GENERAL HOSPITAL

CLASS II CLINICAL

Premature, very-low-birth-weight (VLBW; ≤1500 g) and low-birth-weight (LBW; 1500-2499 g) infants are at increased risk for long-term encephalopathy. 25-50% of the 63,000 VLBW infants born annually in the U.S. have major long-term cognitive or neurobehavioral deficits. Postnatal cerebral ischemia appears to play an important role in long-term cognitive sequelae. Unfortunately, there is currently no technique for easily, repeatedly and noninvasively monitoring or measuring cerebral circulatory adequacy in LBW or VLBW infants. Noninvasix uses a technology, called optoacoustics, which provides a noninvasive and direct monitor of cerebral venous blood oxygen saturation in the superior sagittal sinus (SSSSO2) through the open anterior fontanelle. The accurate monitoring of the adequacy of brain blood flow in very premature infants would permit prompt treatment when brain blood flow is inadequate and could improve long-term brain function.

FLUIDSYNC PUMP, AN IMPLANTABLE DRUG INFUSION MICROPUMP

GENERAL HOSPITAL

CLASS III PRECLINICAL

Currently, only two types of implantable drug infusion pumps are commercially available in the US – constant flow and programmable pumps. The size and weight are prohibitive in pediatric applications (typically the size of a hockey puck and weight of 100-200 g), while the accuracy is at best ±10% to 15% of the programmed flow rate. FluidSync is an implantable drug infusion micropump that allows both spatial and temporal control of drug delivery and will be the first pump miniaturized for use in pediatrics. The device utilizes microelectromechanical systems (MEMS) technologies to miniaturize device components in a precise and reproducible manner. This enables a 100% increase in volume efficiency of the overall device, a 50% reduction in size and weight, and five times better dosing accuracy compared to adult implantable pumps on the market today. This pump will introduce a revolutionary approach to treatment that directly provides therapeutic drug concentration in the intrathecal space over sustained periods to reach optimal efficacy.

TESI, A P-O-C CELL PROCESSING DEVICE FOR TREATING SMALL BOWEL SYNDROME

GASTROENTEROLOGY AND UROLOGY

CLASS III PRECLINICAL

Necrotizing enterocolitis (NEC) is a gastrointestinal disease that affects premature infants. The current standard of care requires surgical removal of necrotized tissue, which requires life-long management of nutritional insufficiencies (transplant and/or arterial line feeding) associated with short bowel syndrome. TESI is a device-based kit for processing salvaged small intestinal tissue during surgery to create bowel segments for implantation. A subset of cells is seeded on a biodegradable scaffold, which is implanted into the patient resulting in autologous tissue-engineered intestines. A proof of concept has been obtained in non-clinical models and pediatric scalability is being pursued in non-clinical studies.

MRU CLUSTERTM, A CLINICAL DECISION SUPPORT TOOL FOR DIAGNOSIS OF CKD

GASTROENTEROLOGY AND UROLOGY

CLASS II CLINICAL

Early detection of Chronic Kidney Disease (CKD) currently requires multiple time-consuming, costly tests with catheterizations and radiation exposure. MRI provides only anatomic data, nuclear medicine provides functional data, but requires ionizing radiation and nephron counts are invasive. Both anatomic and functional data are required to make the best treatment decisions. MRUcluster™ will enable earlier diagnosis of CKD by providing all 3 parameters safely in a single cost-effective quantitative MRI exam, while decreasing overall system cost. MRUcluster™ analyzes both anatomical and functional parameters of the kidney, including renal transit time, urinary excretion, renal blood flow, glomerular filtration rate, plasma flow or volume etc. The software uses a cluster-based method to analyze and automatically segment the 3D MRI kidney data on a pixel-by-pixel basis into clusters with similar functional activities. The software then uses these clusters, in combination with anatomical knowledge and logistic modeling to automatically segment the kidney for further evaluation. The software is ready for clinical validation.

BIORESORBABLE FISTULA PATCH

GASTROENTEROLOGY AND UROLOGY CLASS III CONCEPT

Hypospadias is a condition in which the opening of the urethra is on the underside of the penis, instead of at the tip. Hypospadias repairs are performed using local tissue, often resulting in fistula formation. Harvest and imposition of barrier layers have helped decrease urethrocutaneous (UC) fistulas but have not completely eliminated them. When hypospadias is severe, the fistula rate is greater than 50%. Even after UC fistula repairs, recurrence of fistulas range from 33 to 100%. The unique feature of this technology is the design of submicron pores in the matrix. Imposition of a bioabsorbable matrix layer with submicron pores above the repaired urethra as a barrier during wound healing will prevent formation of UC fistulas. With a bioabsorable matrix that promotes natural wound healing, fibrosis should not occur from the use of the scaffold and thus prevent future curvature of the penis. This technology could also be used with cleft palate repairs, another disease plagued with fistulization problems.

MODIFLOW, A NOVEL SPACER THAT OPTIMIZES DRUG DELIVERY

IMMUNOLOGY

CLASS II PROTOTYPE

Asthma is a widespread disease affecting more than 300 million individuals worldwide. The treatment in children is based upon an administration of a pressurized metered-dose inhaler added with a spacer. The efficiency of drug delivery to the patient is strongly affected by the transient airflow pattern inside the spacer device. ModiFlow is a unique spacer with an optimized inner geometry that improves the efficiency of medication delivery by minimizing turbulence in aerosolized drug delivery. ModiFlow can be either a standalone spacer or its inner design structure can be potentially incorporated into all existing spacers to improve their performance. The principals of flow modification used in ModiFlow have universality that is applicable in any device concerned with transfer of fluid, gas, or information. Potential targets include endotracheal tubes, oxygen masks, and attachments to nebulizer machines, enteral systems, infant bottles, IV systems, medial error prevention systems, and others.

VAXIMMUNE, A POINT OF CARE PATHOGEN DIAGNOSTIC KIT

IMMUNOLOGY

CLASS II

Infections transmitted from mother to baby present a significant health economic burden. Preterm Infants have a 35% risk of being infected by their mother with Ureaplasma bacteria, developing pneumonia and chronic lung disease (bronchopulmonary dysplasia or BPD). In the US and Canada, There are over 120,000 babies/year that are born before 33 weeks gestation and at least 42,000 develop Ureaplasma congenital pneumonia. Worldwide there are over 3.2 million preterm births <33 weeks gestation. While Treatment in the first 3 days of life with a commonly available antibiotic prevents BPD in 20 to 30% of patients, Ureaplasma pneumonia in preterm infants is largely an undiagnosed and untreated condition due to the lack of a diagnostic test available at the time of birth. Vaximmune is developing a POC diagnostic kit which detects Ureaplasma and other common bacterial infections at birth. This rapid diagnostic kit platform allows the clinician to make the right diagnosis at the right time and treat with the right antibiotic immediately.

PRECLINICAL

CLICK BRAIN, A CLINICAL DECISION SUPPORT TOOL TO EVALUATE BRAIN MR IMAGES

NEUROLOGY

CLASS II

The current standard of care using pediatric brain MRI for assessment of developmental disorders, neurological trauma and diseases is time-consuming, qualitative, and requires visual assessment of a multitude of 2D images. ClickBrain™ is a reimbursable, quantitative translational clinical decision support software that compares patients’ brain MRI morphometry to healthy normal subjects. ClickBrain™ is intended to significantly impact patient care by 1) increasing efficiency of interpretation and reporting, 2) promoting uniformity of interpretation regardless of radiologist experience level, thus reducing risk of misdiagnosis, and 3) enabling earlier diagnosis and quantitative longitudinal studies for treatment monitoring.

M.I.N.D DIAGNOSTIC, A NEUROPSYCHIATRIC DISORDERS DIAGNOSTIC SOFTWARE

NEUROLOGY CLASS II CLINICAL

Nearly 2 billion people worldwide and 100 million people in the US are affected by a brain or nervous system disorder including addiction, Alzheimer’s, depression, anxiety, schizophrenia, attention disorders, epilepsy, Parkinson’s disease, sensory disorders, and sleep disorders. Unfortunately, diagnosis is based on qualitative judgment of a patient’s clinical symptoms that typically only present themselves in late stages of disorders. Although some biomarkers have been developed for detection of a few neuropsychiatric disorders, they are limited to late stages and have poor sensitivity and specificity. This software will provide highly accurate diagnosis of many neuropsychiatric disorders, as well as comorbidity, based solely on measuring physiology and pathology of the brain using images obtained by magnetic resonance imaging (MRI). This software employs MRI-based algorithms, which use local variation in different morphological brain features that are sensitive to differences between healthy individuals and patients with diagnosed psychiatric illnesses.

TIMESTAMP, AN IMPROVED CSF FLOW IMAGING SOFTWARE

NEUROLOGY

CLASS II PROTOTYPE

Cerebrospinal fluid (CSF) flow can de obstructed due to a variety of medical conditions such as infections, meningitis, brain tumors, traumatic injuries etc. Because CSF is made continuously, medical conditions that block its normal flow will result in an over-accumulation of CSF. The resulting pressure of the fluid against brain tissue causes hydrocephalus. The incidence of pediatric hydrocephalous is about 1/1,000 births and early detection of CSF flow obstruction is a key component for proper treatment selection and diminution of downstream effects. Current techniques generate images that lose tissue/CSF contrast over the image capture process thereby complicating the radiologist's ability to identify CSF flow obstruction. TimeStamp is a new MRI-based image acquisition software that allows MRI images to maintain high image contrast for easier and faster interpretation by the radiologist.

NEURAL ANALYTICS, AN OBJECTIVE DIAGNOSTIC TOOL FOR TBI

NEUROLOGY

CLASS II

There is an urgent need for an accessible, objective diagnosis of acute mild traumatic brain injury (TBI). Between 1.6 and 3.8 million people each year suffer a mild TBI in the US alone. It is estimated that 60% of all TBIs go undiagnosed which can lead secondary neurological deterioration, in as many as 30% of undiagnosed patients. Neural Analytics, Inc. is developing a portable, easy to use device for reliable and objective mild TBI diagnosis in under ten minutes that can be used at the point of injury, such as athletic sidelines, battlefield, etc.

CLINICAL

PROTOTYPE

HANGAR HUSTLE, A GAME-BASED COGNITIVE ASSESSMENT TEST

NEUROLOGY

CLASS I PROTOTYPE

Attention deficits affect millions of people in the US; the percent of children 3-17 years of age with ADHD is 9.5% and the prevalence of ADHD in the U.S. adult population is approximately 4.4%. Beyond the personal costs to relationships, education, employment, is the economic cost to the nation in accidents, lost productivity, and additional healthcare services. Expeditious assessment means earlier access to treatment that will reduce the personal and economic impact of cognitive impairments. Blue Marble has developed an innovative game-based assessment tool designed to measure various forms of attention, working memory and executive functions in the course of video game play. This tool is intended to replace current paper-based or computerized assessment that are cumbersome, time consuming and non-engaging for the patient. Using this new technology will reduce the per-patient cost for assessment and will therefore stretch resources farther to serve more people.

SELF-AWARE HYDROCEPHALUS SHUNT

NEUROLOGY CLASS II

Hydrocephalus is characterized by the excess accumulation of cerebrospinal fluid (CSF) in the lateral ventricles. Standard treatment is to place an invasive CSF shunt to drain the excess fluid. However, shunts are plagued by high failure rate amounting to a staggering 40% failure rate in the first year of use to 85% within ten years irrespective of the specific type of hardware used or the insertion method. The primary cause of failure is obstruction of the inlet ports in the proximal catheter placed in the ventricles. There is currently no reliable non-invasive method to detect shunt failure which is a progressive process. This device provides a non-invasive, wirelessly-operated multi-sensor module that is compatible with standard shunt sets to enable a self-aware hydrocephalus shunt. Two sensor types are used to enable detection of (1) shunt obstruction, (2) flow of CSF, and (3) intracranial pressure. Electronic monitoring of shunts will reduce mortality and secondary injuries and thereby reduce costs associated with emergency room admission and eliminated the use of ineffective diagnostic tests that are currently employed. The wirelessly interrogated shunt will enable, for the first time, an objective method for diagnosing shunt dysfunction as well as a means for real-time monitoring of hydrocephalus-shunt hydrodynamics to enable both better patient care and correlation of treatment to disease progression.

MAR TEST, AN AUTISM SPECTRUM DISORDERS DIAGNOSTIC ASSAY

NEUROLOGY CLASS II

Autism is a behavioral disorder, and the incidence has increased dramatically in recent years. It is currently estimated that 1 in 68 live births or over 60,000 children in the US each year will be diagnosed with Autism Spectrum Disorder (ASD). Studies have shown that with early intensive behavioral intervention (EIBI) starting by age 2 or 3, up to 50% of these children will be able to attend mainstream schools. Unfortunately, the current average age of diagnosis is 4.5 years, well past the critical window of opportunity for effective intervention Autoantibody biomarkers have been discovered in the blood of a significant percentage of mothers with autistic children. This subtype of autism, Maternal Antibody Related Autism (MAR), may account for at least 23% of the total cases of autism. The MAR test would be offered to "at risk" women such as women, who already had a child with autism, mothers of young children who are developmentally delayed and women who are over 35 years and are contemplating a pregnancy.

PROTOTYPE

CLINICAL

NEUROBLASTOMA PROGNOSTIC ASSAY

PATHOLOGY

CLASS II CLINICAL

Neuroblastoma, an embryonal tumor of the peripheral sympathetic nervous system, is one of the most common solid tumors in children, with approximately 45% of patients presenting with metastatic disease at diagnosis. Only 45% of those with high-risk metastatic neuroblastoma are cured with current treatments that include intensive chemotherapy and immunotherapy. Having a new means to identify individuals at extremely high-risk for disease progression and to assess response to therapy would be valuable for disease management. This 14-gene prognostic assay identifies high and ultra-high risk groups and a highly sensitive and specific 5-gene response assay to quantify circulating and bone marrow tumor cells in patients with neuroblastoma. These tests represent an integrated disease management platform that may be particularly useful in adapting and evaluating treatments, and in predicting outcome in children with neuroblastoma. A novel method for recovering high quality RNA from viable fresh and frozen specimens was established for use in these tests. This platform, with modifications, may also be useful in adults with cancer.

MEDULLOBLASTOMA DIAGNOSTIC ASSAY

PATHOLOGY

CLASS II

Medulloblastoma is the most common malignant pediatric brain tumor. Approximately 30% of patients remain incurable and current radiation therapy containing treatment protocols cause significant adverse long-term neurocognitive effects and endocrine dysfunction. In order to increase survival rates and reduce adverse sequelae, there is a need of early detection methods and refined patient stratification. This 31-gene diagnostic assay allows accurate identification of medulloblastoma subgroups and examines the expression of inflammation-related genes with respect to each subgroup. Treatment for medulloblastoma is currently conducted with a multi-modality approach (surgery, radiation therapy and chemotherapy) and the modality is heavily dependent on tumor staging and risk group categorization. The molecular classification of medulloblastoma using this platform will greatly improve current clinical risk stratification and therefore help with choosing the more efficient treatment for the patient.

CLINICAL